A Multi-Center Study of Nonmyeloablative Conditioning With TBI or Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies With Post Grafting Immunosuppression With Tacrolimus and Mycophenolate Mofetil
Phase 2
N/A
74 Years
N/A
74 Years
Open (Enrolling)
Both
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Eosinophilic Leukemia, Chronic Neutrophilic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Burkitt Lymphoma, Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Contiguous Stage II Adult Lymphoblastic Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma, Contiguous Stage II Mantle Cell Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, de Novo Myelodysplastic Syndromes, Essential Thrombocythemia, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Adult Burkitt Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Noncontiguous Stage II Adult Lymphoblastic Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Peripheral T-cell Lymphoma, Polycythemia Vera, Post-transplant Lymphoproliferative Disorder, Previously Treated Myelodysplastic Syndromes, Primary Myelofibrosis, Prolymphocytic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Multiple Myeloma, Relapsing Chronic Myelogenous Leukemia, Secondary Myelodysplastic Syndromes, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Stage I Adult Burkitt Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Mixed Cell Lymphoma, Stage I Adult Diffuse Small Cleaved Cell Lymphoma, Stage I Adult Immunoblastic Large Cell Lymphoma, Stage I Adult Lymphoblastic Lymphoma, Stage I Adult T-cell Leukemia/Lymphoma, Stage I Childhood Anaplastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Lymphoblastic Lymphoma, Stage I Chronic Lymphocytic Leukemia, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Grade 3 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Multiple Myeloma, Stage I Mycosis Fungoides/Sezary Syndrome, Stage I Small Lymphocytic Lymphoma, Stage II Adult T-cell Leukemia/Lymphoma, Stage II Childhood Anaplastic Large Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Lymphoblastic Lymphoma, Stage II Chronic Lymphocytic Leukemia, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Multiple Myeloma, Stage II Mycosis Fungoides/Sezary Syndrome, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Adult T-cell Leukemia/Lymphoma, Stage III Childhood Anaplastic Large Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Lymphoblastic Lymphoma, Stage III Chronic Lymphocytic Leukemia, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Multiple Myeloma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Adult T-cell Leukemia/Lymphoma, Stage IV Childhood Anaplastic Large Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Lymphoblastic Lymphoma, Stage IV Chronic Lymphocytic Leukemia, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Mycosis Fungoides/Sezary Syndrome, Stage IV Small Lymphocytic Lymphoma, Testicular Lymphoma, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia, Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies, Waldenström Macroglobulinemia
Both
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Eosinophilic Leukemia, Chronic Neutrophilic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Burkitt Lymphoma, Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Contiguous Stage II Adult Lymphoblastic Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma, Contiguous Stage II Mantle Cell Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, de Novo Myelodysplastic Syndromes, Essential Thrombocythemia, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Adult Burkitt Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma, Noncontiguous Stage II Adult Lymphoblastic Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Peripheral T-cell Lymphoma, Polycythemia Vera, Post-transplant Lymphoproliferative Disorder, Previously Treated Myelodysplastic Syndromes, Primary Myelofibrosis, Prolymphocytic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Multiple Myeloma, Relapsing Chronic Myelogenous Leukemia, Secondary Myelodysplastic Syndromes, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Stage I Adult Burkitt Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Mixed Cell Lymphoma, Stage I Adult Diffuse Small Cleaved Cell Lymphoma, Stage I Adult Immunoblastic Large Cell Lymphoma, Stage I Adult Lymphoblastic Lymphoma, Stage I Adult T-cell Leukemia/Lymphoma, Stage I Childhood Anaplastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Lymphoblastic Lymphoma, Stage I Chronic Lymphocytic Leukemia, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Grade 3 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Multiple Myeloma, Stage I Mycosis Fungoides/Sezary Syndrome, Stage I Small Lymphocytic Lymphoma, Stage II Adult T-cell Leukemia/Lymphoma, Stage II Childhood Anaplastic Large Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Lymphoblastic Lymphoma, Stage II Chronic Lymphocytic Leukemia, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Multiple Myeloma, Stage II Mycosis Fungoides/Sezary Syndrome, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Adult T-cell Leukemia/Lymphoma, Stage III Childhood Anaplastic Large Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Lymphoblastic Lymphoma, Stage III Chronic Lymphocytic Leukemia, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Multiple Myeloma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Adult T-cell Leukemia/Lymphoma, Stage IV Childhood Anaplastic Large Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Lymphoblastic Lymphoma, Stage IV Chronic Lymphocytic Leukemia, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Mycosis Fungoides/Sezary Syndrome, Stage IV Small Lymphocytic Lymphoma, Testicular Lymphoma, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia, Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies, Waldenström Macroglobulinemia
Trial Information
A Multi-Center Study of Nonmyeloablative Conditioning With TBI or Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies With Post Grafting Immunosuppression With Tacrolimus and Mycophenolate Mofetil
PRIMARY OBJECTIVES:
I. To estimate the incidence of grade III/IV graft-versus-host disease (GVHD) after
conditioning with 200 cGy total-body irradiation (TBI) alone or Fludarabine (fludarabine
phosphate)/200 cGy TBI followed by tacrolimus (Tac)/mycophenolate mofetil (MMF)
immunosuppression in patients with hematologic malignancies.
II. To estimate the incidence of chronic extensive GVHD.
SECONDARY OBJECTIVES:
I. To estimate the incidences of graft rejection.
II. To estimate overall survival 1-year after conditioning.
III. To evaluate the incidences of grades II-IV acute GVHD.
IV. To evaluate the rates of disease progression and/or relapse-related mortality.
V. To estimate the rate and duration of steroid use for the treatment of chronic GVHD.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I (nonmyeloablative conditioning with fludarabine phosphate and TBI): Patients receive
fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo TBI on day 0.
ARM II (nonmyeloablative conditioning with TBI): Patients undergo TBI on day 0.
All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and
receive tacrolimus orally (PO) every 12 hours on days -3 to 180, with taper on day 56, or
tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days
0-28 or mycophenolate mofetil IV if unable to tolerate PO.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years,
and then annually thereafter.
Inclusion Criteria:
- Patient must be not eligible for conventional allogeneic hematopoietic cell
transplantation (HCT) and must have disease expected to be stable for at least 100
days without chemotherapy; patients with hematologic malignancies treatable with HCT
or with a B cell malignancy except those curable with autologous transplant will be
included; patients not eligible for active disease specific protocols, may be
enrolled in this protocol
- Diffuse large B cell non-Hodgkin lymphoma (NHL) and other aggressive Lymphomas not
eligible for conventional myeloablative HCT or after autologous HCT
- Low grade NHL- with < 6 months duration of complete response (CR) between courses of
conventional therapy
- Mantle cell NHL- may be treated in first CR
- Chronic lymphocytic leukemia (CLL)- must have either
- 1) failed to meet NCI Working Group criteria for complete or partial response
after therapy with a regimen containing FLU (or another nucleoside analog, e.g.
2-CDA, pentostatin) or experience disease relapse within 12 months after
completing therapy with a regimen containing FLU (or another nucleoside analog);
- 2) failed FLU-CY-Rituximab (FCR) combination chemotherapy at any time point; or
- 3) have "17p deletion" cytogenetic abnormality; patients should have received
induction chemotherapy but could be transplanted in 1st CR
- 4) patients with a diagnosis of CLL (or small lymphocytic lymphoma) or a
diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), to T-cell CLL
or PLL
- Hodgkin Lymphoma (HL)- must have received and failed frontline therapy; patients must
have failed or were not eligible for autologous transplant
- Multiple myeloma (MM)- following a planned autologous transplant or equivalent
high-dose therapy without a graft, or following a failed prior autograft
- Acute myeloid leukemia (AML)- must have < 5% marrow blasts at the time of transplant
- Acute lymphoblastic leukemia (ALL)- must have < 5% marrow blasts at the time of
transplant
- Chronic myelogenous leukemia (CML)- patients will be accepted beyond CP1 if they have
received previous myelosuppressive chemotherapy or HCT, and have < 5% marrow blasts
at time of transplant
- Myelodysplastic syndromes/myeloproliferative disorders (MDS/MPD)- must have received
previous myelosuppressive chemotherapy or HCT and have < 5% marrow blasts at time of
transplant
- Waldenstrom's Macroglobulinemia- must have failed 2 courses of therapy
- Myelosuppressive chemotherapy must be discontinued three weeks prior to conditioning
with the exception of hydroxyurea or imatinib
- Patients < 12 years old must be approved by both the participating institutions'
patient review committee such as the Patient Care Conference (PCC) at the FHCRC and
the FHCRC principal investigator
- Patient who refused to be treated on a conventional HCT protocol; for this inclusion
criterion, transplants must be approved by both the participating institution's
patient review committee such as the Patient Care Conference (PCC) at the FHCRC and
the FHCRC principal investigators
- Patients with human leukocyte antigen (HLA)-matched related donors
- Patients with renal failure are eligible; however, patients with renal compromise
(serum creatinine > 2.0) will likely have further compromise in renal function and
may require hemodialysis (which may be permanent) due to the need to maintain
adequate serum tacrolimus levels
- DONOR: Related donor who is HLA genotypically identical at least at one haplotype and
may be phenotypically or genotypically identical at the allele level at HLA-A, -B,
-C, -DRB1, and -DQB1
- DONOR: Donor must consent to G-CSF administration and leukapheresis
- DONOR: Donor must have adequate veins for leukapheresis or agree to placement of
central venous catheter (femoral, subclavian)
Exclusion Criteria:
- Eligible for a high priority curative autologous transplant
- Patient with rapidly progressive, aggressive NHL unless in minimal disease state
- Patients with chronic myelomonocytic leukemia (CMML)
- Life expectancy severely limited by diseases other than malignancy
- Any current central nervous system (CNS) involvement with disease refractory to
intrathecal chemotherapy
- Presence of circulating leukemic blasts (in the peripheral blood) detected by
standard pathology for patients with AML, ALL or CML
- Fertile men or women unwilling to use contraceptives during and for up to 12 months
post treatment
- Female patients who are pregnant or breastfeeding
- Human immunodeficiency virus (HIV)-positive patients
- Patients with active non-hematologic malignancies (except non-melanoma skin cancers);
this exclusion does not apply to patients with non-hematologic malignancies that do
not require therapy
- Patients with a history of non-hematologic malignancies (except non-melanoma skin
cancers) currently in a complete remission, who are less than 5 years from the time
of complete remission, and have a > 20% risk of disease recurrence; this exclusion
does not apply to patients with non-hematologic malignancies that do not require
therapy
- Fungal pneumonia with radiological progression after receipt of amphotericin
formulation or mold-active azoles for greater than 1 month
- Karnofsky score < 50 for adult patients
- Lansky-Play Performance Score < 50 for pediatric patients
- Symptomatic coronary artery disease or ejection fraction < 35% or other cardiac
failure requiring therapy (or, if unable to obtain ejection fraction, shortening
fraction of < 26%); ejection fraction is required if age > 50 years or there is a
history of anthracycline exposure or history of cardiac disease; patients with a
shortening fraction < 26% may be enrolled if approved by a cardiologist
- Poorly controlled hypertension
- Diffusing capacity of the lung for carbon monoxide (DLCO) < 30%, total lung capacity
(TLC) < 30%, forced expiratory volume in one second (FEV1) < 30% and/or receiving
supplementary continuous oxygen; the FHCRC PI of the study must approve enrollment of
all patients with pulmonary nodules
- Liver function abnormalities: Patients with clinical or laboratory evidence of liver
disease would be evaluated for the cause of liver disease, its clinical severity in
terms of liver function, and the degree of portal hypertension; patients will be
excluded if they are found to have fulminant liver failure, cirrhosis of the liver
with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis,
esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy,
uncorrectable hepatic synthetic dysfunction evinced by prolongation of the
prothrombin time, ascites related to portal hypertension, bacterial or fungal liver
abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3
mg/dL, and symptomatic biliary disease
- Patients with active bacterial or fungal infections unresponsive to medical therapy
- DONOR: Age less than 12 years
- DONOR: Identical twin
- DONOR: Pregnancy
- DONOR: Infection with HIV
- DONOR: Known allergy to filgrastim (G-CSF)
- DONOR: Current serious systemic illness that would result in increased risk for G-CSF
mobilization and harvest of peripheral blood stem cells (PBSC)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of grade III/IV GVHD
Outcome Time Frame:
Day 180 post-transplantation
Safety Issue:
No
Principal Investigator
David Maloney
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Authority:
United States: Food and Drug Administration
Study ID:
1898.00
NCT ID:
NCT00089011
Start Date:
April 2004
Completion Date:
Related Keywords:
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Blastic Phase Chronic Myelogenous Leukemia
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Burkitt Lymphoma
- Childhood Chronic Myelogenous Leukemia
- Childhood Diffuse Large Cell Lymphoma
- Childhood Immunoblastic Large Cell Lymphoma
- Childhood Myelodysplastic Syndromes
- Childhood Nasal Type Extranodal NK/T-cell Lymphoma
- Chronic Eosinophilic Leukemia
- Chronic Neutrophilic Leukemia
- Chronic Phase Chronic Myelogenous Leukemia
- Contiguous Stage II Adult Burkitt Lymphoma
- Contiguous Stage II Adult Diffuse Large Cell Lymphoma
- Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
- Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
- Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
- Contiguous Stage II Adult Lymphoblastic Lymphoma
- Contiguous Stage II Grade 1 Follicular Lymphoma
- Contiguous Stage II Grade 2 Follicular Lymphoma
- Contiguous Stage II Grade 3 Follicular Lymphoma
- Contiguous Stage II Mantle Cell Lymphoma
- Contiguous Stage II Marginal Zone Lymphoma
- Contiguous Stage II Small Lymphocytic Lymphoma
- Cutaneous B-cell Non-Hodgkin Lymphoma
- de Novo Myelodysplastic Syndromes
- Essential Thrombocythemia
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Hepatosplenic T-cell Lymphoma
- Intraocular Lymphoma
- Nodal Marginal Zone B-cell Lymphoma
- Noncontiguous Stage II Adult Burkitt Lymphoma
- Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
- Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
- Noncontiguous Stage II Adult Lymphoblastic Lymphoma
- Noncontiguous Stage II Grade 1 Follicular Lymphoma
- Noncontiguous Stage II Grade 2 Follicular Lymphoma
- Noncontiguous Stage II Grade 3 Follicular Lymphoma
- Noncontiguous Stage II Mantle Cell Lymphoma
- Noncontiguous Stage II Marginal Zone Lymphoma
- Noncontiguous Stage II Small Lymphocytic Lymphoma
- Peripheral T-cell Lymphoma
- Polycythemia Vera
- Post-transplant Lymphoproliferative Disorder
- Previously Treated Myelodysplastic Syndromes
- Primary Myelofibrosis
- Prolymphocytic Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Recurrent Childhood Grade III Lymphomatoid Granulomatosis
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic Lymphoma
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Multiple Myeloma
- Relapsing Chronic Myelogenous Leukemia
- Secondary Myelodysplastic Syndromes
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- Stage I Adult Burkitt Lymphoma
- Stage I Adult Diffuse Large Cell Lymphoma
- Stage I Adult Diffuse Mixed Cell Lymphoma
- Stage I Adult Diffuse Small Cleaved Cell Lymphoma
- Stage I Adult Immunoblastic Large Cell Lymphoma
- Stage I Adult Lymphoblastic Lymphoma
- Stage I Adult T-cell Leukemia/Lymphoma
- Stage I Childhood Anaplastic Large Cell Lymphoma
- Stage I Childhood Large Cell Lymphoma
- Stage I Childhood Lymphoblastic Lymphoma
- Stage I Chronic Lymphocytic Leukemia
- Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage I Grade 1 Follicular Lymphoma
- Stage I Grade 2 Follicular Lymphoma
- Stage I Grade 3 Follicular Lymphoma
- Stage I Mantle Cell Lymphoma
- Stage I Marginal Zone Lymphoma
- Stage I Multiple Myeloma
- Stage I Mycosis Fungoides/Sezary Syndrome
- Stage I Small Lymphocytic Lymphoma
- Stage II Adult T-cell Leukemia/Lymphoma
- Stage II Childhood Anaplastic Large Cell Lymphoma
- Stage II Childhood Large Cell Lymphoma
- Stage II Childhood Lymphoblastic Lymphoma
- Stage II Chronic Lymphocytic Leukemia
- Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage II Multiple Myeloma
- Stage II Mycosis Fungoides/Sezary Syndrome
- Stage III Adult Burkitt Lymphoma
- Stage III Adult Diffuse Large Cell Lymphoma
- Stage III Adult Diffuse Small Cleaved Cell Lymphoma
- Stage III Adult Immunoblastic Large Cell Lymphoma
- Stage III Adult Lymphoblastic Lymphoma
- Stage III Adult T-cell Leukemia/Lymphoma
- Stage III Childhood Anaplastic Large Cell Lymphoma
- Stage III Childhood Large Cell Lymphoma
- Stage III Childhood Lymphoblastic Lymphoma
- Stage III Chronic Lymphocytic Leukemia
- Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage III Grade 1 Follicular Lymphoma
- Stage III Grade 2 Follicular Lymphoma
- Stage III Grade 3 Follicular Lymphoma
- Stage III Mantle Cell Lymphoma
- Stage III Marginal Zone Lymphoma
- Stage III Multiple Myeloma
- Stage III Mycosis Fungoides/Sezary Syndrome
- Stage III Small Lymphocytic Lymphoma
- Stage IV Adult Burkitt Lymphoma
- Stage IV Adult Diffuse Large Cell Lymphoma
- Stage IV Adult Diffuse Mixed Cell Lymphoma
- Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
- Stage IV Adult Immunoblastic Large Cell Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Stage IV Adult T-cell Leukemia/Lymphoma
- Stage IV Childhood Anaplastic Large Cell Lymphoma
- Stage IV Childhood Large Cell Lymphoma
- Stage IV Childhood Lymphoblastic Lymphoma
- Stage IV Chronic Lymphocytic Leukemia
- Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage IV Grade 1 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Mantle Cell Lymphoma
- Stage IV Marginal Zone Lymphoma
- Stage IV Mycosis Fungoides/Sezary Syndrome
- Stage IV Small Lymphocytic Lymphoma
- Testicular Lymphoma
- Untreated Adult Acute Lymphoblastic Leukemia
- Untreated Adult Acute Myeloid Leukemia
- Untreated Childhood Acute Lymphoblastic Leukemia
- Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
- Waldenström Macroglobulinemia
- Congenital Abnormalities
- Primary Myelofibrosis
- Blast Crisis
- Burkitt Lymphoma
- Neoplasms
- Graft vs Host Disease
- Hodgkin Disease
- Immunoblastic Lymphadenopathy
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myeloid, Accelerated Phase
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Leukemia, Neutrophilic, Chronic
- Leukemia, Prolymphocytic
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphomatoid Granulomatosis
- Lymphoproliferative Disorders
- Waldenstrom Macroglobulinemia
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Mycoses
- Mycosis Fungoides
- Myelodysplastic Syndromes
- Preleukemia
- Polycythemia
- Polycythemia Vera
- Sezary Syndrome
- Thrombocythemia, Essential
- Lymphoma, B-Cell
- Lymphoma, Large-Cell, Immunoblastic
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, T-Cell, Peripheral
- Hypereosinophilic Syndrome
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, B-Cell, Marginal Zone
- Lymphoma, Extranodal NK-T-Cell
- Lymphoma, Mantle-Cell
- Thrombocytosis
Name | Location |
|---|---|
| LDS Hospital | Salt Lake City, Utah 84143 |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
| Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
| Veterans Administration Center-Seattle | Seattle, Washington 98108 |
