Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Reduced-intensity Preparative Regimen
Phase 2
N/A
70 Years
N/A
70 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 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), Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Acute Myelomonocytic Leukemia (M4), Childhood Anaplastic Large Cell Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Contiguous Stage II Adult Lymphoblastic Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, de Novo Myelodysplastic Syndromes, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Juvenile Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell 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, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, 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 Anemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Refractory Anemia With Ringed Sideroblasts, Refractory Chronic Lymphocytic Leukemia, Refractory Cytopenia With Multilineage Dysplasia, Refractory Hairy Cell Leukemia, Refractory Multiple Myeloma, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Splenic Marginal Zone 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 Hodgkin Lymphoma, Stage I Adult Immunoblastic Large Cell Lymphoma, Stage I Adult Lymphoblastic Lymphoma, Stage I Childhood Anaplastic Large Cell Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Lymphoblastic Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, 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 Marginal Zone Lymphoma, Stage I Multiple Myeloma, Stage I Mycosis Fungoides/Sezary Syndrome, Stage I Small Lymphocytic Lymphoma, Stage II Adult Hodgkin Lymphoma, Stage II Childhood Anaplastic Large Cell Lymphoma, Stage II Childhood Hodgkin Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Lymphoblastic Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Multiple Myeloma, Stage II Mycosis Fungoides/Sezary Syndrome, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Childhood Anaplastic Large Cell Lymphoma, Stage III Childhood Hodgkin 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 Marginal Zone Lymphoma, Stage III Multiple Myeloma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage III Small Lymphocytic 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 Hodgkin Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Childhood Anaplastic Large Cell Lymphoma, Stage IV Childhood Hodgkin 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, 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 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), Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Acute Myelomonocytic Leukemia (M4), Childhood Anaplastic Large Cell Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Contiguous Stage II Adult Lymphoblastic Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, de Novo Myelodysplastic Syndromes, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Juvenile Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell 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, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, 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 Anemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Refractory Anemia With Ringed Sideroblasts, Refractory Chronic Lymphocytic Leukemia, Refractory Cytopenia With Multilineage Dysplasia, Refractory Hairy Cell Leukemia, Refractory Multiple Myeloma, Relapsing Chronic Myelogenous Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Splenic Marginal Zone 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 Hodgkin Lymphoma, Stage I Adult Immunoblastic Large Cell Lymphoma, Stage I Adult Lymphoblastic Lymphoma, Stage I Childhood Anaplastic Large Cell Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Lymphoblastic Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, 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 Marginal Zone Lymphoma, Stage I Multiple Myeloma, Stage I Mycosis Fungoides/Sezary Syndrome, Stage I Small Lymphocytic Lymphoma, Stage II Adult Hodgkin Lymphoma, Stage II Childhood Anaplastic Large Cell Lymphoma, Stage II Childhood Hodgkin Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Lymphoblastic Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Multiple Myeloma, Stage II Mycosis Fungoides/Sezary Syndrome, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage III Adult Immunoblastic Large Cell Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Childhood Anaplastic Large Cell Lymphoma, Stage III Childhood Hodgkin 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 Marginal Zone Lymphoma, Stage III Multiple Myeloma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage III Small Lymphocytic 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 Hodgkin Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Childhood Anaplastic Large Cell Lymphoma, Stage IV Childhood Hodgkin 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, Waldenström Macroglobulinemia
Trial Information
Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Reduced-intensity Preparative Regimen
PRIMARY OBJECTIVES:
I. Estimate probability of one year survival.
II. Demonstrate equivalent or improved engraftment rates with a non-anti-thymocyte globulin
(ATG) based conditioning regimen. Patients will be considered graft failure/rejections
provided they meet any of the criteria listed below:
- Absence of 3 consecutive days with neutrophils >= 500/ul combined with host CD3
peripheral blood chimerism >= 50% at day 42
- Absence of 3 consecutive days with neutrophils >= 500/ul under any circumstances at day
55
- Death after day 28 with neutrophil count < 100/ul without any evidence of engraftment
(< 5% donor CD3)
- Primary autologous count recovery with < 5% donor CD3 peripheral blood chimerism at
count recovery and without relapse
SECONDARY OBJECTIVES:
I. Six month non-relapse mortality.
II. Overall incidence of graft failure/rejection. Patients will be considered graft
failure/rejections provided they meet any of the criteria listed below:
- Absence of 3 consecutive days with neutrophils >= 500/ul combined with host CD3
peripheral blood chimerism >= 50% at day 42
- Absence of 3 consecutive days with neutrophils >= 500/ul under any circumstances at day
55
- Death after day 28 with neutrophil count < 100/ul without any evidence of engraftment
(< 5% donor CD3)
- Primary autologous count recovery with < 5% donor CD3 peripheral blood chimerism at
count recovery and without relapse.
III. Kinetics of chimeric reconstitution.
IV. Incidence of neutrophil engraftment by day 42.
V. Incidence of platelet engraftment by six months.
VI. Incidence of grade II-IV and III-IV acute graft-versus-host disease (GvHD) for each arm
at day 100.
VII. Incidence of one year chronic GvHD for each arm.
VIII. Incidence of clinically significant infections at 6 months, 1 year, 2 years for each
arm.
IX. Probability of one and two year survival.
X. Incidence of one and two year relapse or disease progression.
XI. Fred Hutchinson Cancer Research Center (FHCRC) patients: Kinetics of immune
reconstitution, with both functional and quantitative assays.
XII. FHCRC patients: Examination of possible immunologic factors leading to emergence of a
dominant unit.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -6
to -2 and cyclophosphamide IV on day -6. Patients undergo a lower dose of total-body
irradiation (TBI) on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day
0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on
days -3 to +180 and mycophenolate mofetil IV or orally (PO) every 8 hours on days -3 to +96.
ARM II:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate and cyclophosphamide as in Arm
I. Patients undergo a higher dose of TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion as in
Arm I.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine and mycophenolate mofetil as in
Arm I.
After completion of study treatment, patients are followed periodically for up to 2 years.
Inclusion Criteria:
- Patients > 70 may be considered if Performance Status > 80% and Comorbidity Score < 3
- Adequate cardiac function defined as absence of decompensated congestive heart
failure, or uncontrolled arrhythmia and:
- Left ventricular ejection fraction >= 35% or
- Fractional shortening > 22%
- Adequate pulmonary function defined as diffusion capacity of carbon monoxide (DLCO) >
30% predicted, and absence of oxygen (O2) requirements
- Adequate hepatic function
- Patients with clinical or laboratory evidence of liver disease will be evaluated for
the cause of liver disease, its clinical severity in terms of liver function,
histology, and the degree of portal hypertension
- Adequate renal function defined as creatinine =< 2.0 mg/dl (adults) or creatinine
clearance > 40 ml/min (pediatrics)
- All adults with a creatinine > 1.2 or a history of renal dysfunction must have
estimated creatinine clearance > 40 ml/min
- Performance status score: Karnofsky (for adults) >= 60; Lansky (for children) score
>= 50
- If recent mold infection, e.g., Aspergillus, must be cleared by infectious disease
- Second hematopoietic cell transplant: Must be >= 3 months after prior myeloablative
transplant
- Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia: Must have < 5% morphologic
marrow blasts in an evaluable marrow (> 25% of normal cellularity for age) collected
less than one month prior to start of conditioning; patients persistently aplastic
for greater than one month since completing last chemotherapy are also eligible with
the approval of the principal investigator (PI) or designee
- Chronic myelogenous leukemia: All types, except refractory blast crisis; chronic
phase patients must have failed or been intolerant to Gleevec or other tyrosine
kinase inhibitors; at time of transplant, patients must have < 5% blasts in an
evaluable marrow (> 25% of normal cellularity for age) by morphology within the bone
marrow
- Myelodysplastic syndrome (MDS): Any subtype; morphologic blasts must be less than 5%
in an evaluable marrow (> 25% of normal cellularity for age); if blasts are 5% or
more, patient requires induction chemotherapy pre-transplant to reduce blast count to
=< 5%; patients who have a hypocellular marrow in the absence of excess blasts that
is related to the underlying disease or as a result of treatment for MDS may also be
eligible with the approval of the principal investigator (PI) or designee
- Large-cell lymphoma and aggressive T-cell lymphoma: With chemotherapy sensitive
disease that has failed autologous transplant or patients who are ineligible for an
autologous transplant; chemotherapy sensitive disease is defined as >= 50% reduction
in the size of the tumor with the chemotherapy regimen immediately preceding
transplant
- Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Must be refractory
to fludarabine or fail to have a complete or partial response after therapy with a
regimen containing fludarabine (or another nucleoside analog, e.g. cladribine
[2-CDA], pentostatin) or experience disease relapse within 12 months after completing
therapy with a regimen containing fludarabine (or another nucleoside analog)
- Hodgkin Disease: Must have received and failed frontline therapy
- Follicular lymphoma, marginal zone B-Cell lymphoma, lymphoplasmacytic lymphoma,
mantle-cell lymphoma, and indolent T-cell lymphomas: Must have progressed with the
most recent remission duration being < 6 months
- Follicular lymphoma, marginal zone B-Cell lymphoma, lymphoplasmacytic lymphoma,
mantle-cell lymphoma, and indolent T-cell lymphomas: Patients with bulky disease
should be considered for debulking chemotherapy before transplant; patients with
refractory disease are eligible, unless they have bulky disease and an estimated
tumor doubling time of less than one month
- Multiple Myeloma: Must have received prior chemotherapy; consolidation of
chemotherapy by autografting prior to nonmyeloablative HCT is permitted
- Myeloproliferative syndromes
- DONOR: Unit selection is based on the cryopreserved total nucleated cell (TNC) dose
and matching at HLA-A, B antigen level and DRB1 allele level typing; while HLA-C
antigen/allele level typing is not considered in the matching criteria, if available,
may be used to optimize unit selection
- DONOR: The patient and the cord blood unit(s) must be matched for at least 4 of 6
loci as defined above
- DONOR: Selection of two umbilical cord blood (UCB) units is allowed to provide
sufficient cell dose
Exclusion Criteria:
- Patients with fulminant liver failure, cirrhosis with evidence of portal hypertension
or bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding
esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic
dysfunction evidenced by prolongation of the prothrombin time will be excluded
- Patients with ascites related to portal hypertension, bacterial or fungal abscess,
biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3mg/dL, and
symptomatic biliary disease will be excluded
- Patients with an available 5-6/6 human leukocyte antigen (HLA)-A, B, DRB1 matched
sibling donor
- Pregnancy or breastfeeding
- Evidence of human immunodeficiency virus (HIV) infection or known HIV positive
serology
- Uncontrolled viral or bacterial infection at the time of study enrollment
- Active or recent (prior 6 month) invasive fungal infection without infectious disease
(ID) consult and approval
- Active central nervous system malignancy
- DONOR: Any cord blood units with < 1.5 x 10^7 total nucleated cells per kilogram
recipient weight
- DONOR: Any cord blood units without the full maternal testing and negative results
for hepatitis A, B, C, HIV, and human T-lymphotropic virus (HTLV-1) viruses
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:
Probability of overall survival
Outcome Time Frame:
At 1 year
Safety Issue:
No
Principal Investigator
Colleen Delaney
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Authority:
United States: Institutional Review Board
Study ID:
2239.00
NCT ID:
NCT00723099
Start Date:
June 2008
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 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)
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
- Blastic Phase Chronic Myelogenous Leukemia
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Acute Myelomonocytic Leukemia (M4)
- Childhood Anaplastic Large Cell Lymphoma
- Childhood Diffuse Large Cell Lymphoma
- Childhood Immunoblastic Large Cell Lymphoma
- Childhood Myelodysplastic Syndromes
- Chronic Myelomonocytic Leukemia
- Chronic Phase Chronic Myelogenous Leukemia
- Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
- Contiguous Stage II Adult Lymphoblastic Lymphoma
- Contiguous Stage II Grade 1 Follicular Lymphoma
- Contiguous Stage II Grade 2 Follicular Lymphoma
- de Novo Myelodysplastic Syndromes
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Juvenile Myelomonocytic Leukemia
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Nodal Marginal Zone B-cell 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
- Previously Treated Myelodysplastic Syndromes
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- 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 Anemia
- Refractory Anemia With Excess Blasts
- Refractory Anemia With Excess Blasts in Transformation
- Refractory Anemia With Ringed Sideroblasts
- Refractory Chronic Lymphocytic Leukemia
- Refractory Cytopenia With Multilineage Dysplasia
- Refractory Hairy Cell Leukemia
- Refractory Multiple Myeloma
- Relapsing Chronic Myelogenous Leukemia
- Secondary Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndromes
- Splenic Marginal Zone 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 Hodgkin Lymphoma
- Stage I Adult Immunoblastic Large Cell Lymphoma
- Stage I Adult Lymphoblastic Lymphoma
- Stage I Childhood Anaplastic Large Cell Lymphoma
- Stage I Childhood Hodgkin Lymphoma
- Stage I Childhood Large Cell Lymphoma
- Stage I Childhood Lymphoblastic Lymphoma
- Stage I Childhood Small Noncleaved Cell Lymphoma
- 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 Marginal Zone Lymphoma
- Stage I Multiple Myeloma
- Stage I Mycosis Fungoides/Sezary Syndrome
- Stage I Small Lymphocytic Lymphoma
- Stage II Adult Hodgkin Lymphoma
- Stage II Childhood Anaplastic Large Cell Lymphoma
- Stage II Childhood Hodgkin Lymphoma
- Stage II Childhood Large Cell Lymphoma
- Stage II Childhood Lymphoblastic Lymphoma
- Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage II Multiple Myeloma
- Stage II Mycosis Fungoides/Sezary Syndrome
- Stage III Adult Diffuse Large Cell Lymphoma
- Stage III Adult Diffuse Mixed Cell Lymphoma
- Stage III Adult Diffuse Small Cleaved Cell Lymphoma
- Stage III Adult Hodgkin Lymphoma
- Stage III Adult Immunoblastic Large Cell Lymphoma
- Stage III Adult Lymphoblastic Lymphoma
- Stage III Childhood Anaplastic Large Cell Lymphoma
- Stage III Childhood Hodgkin 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 Marginal Zone Lymphoma
- Stage III Multiple Myeloma
- Stage III Mycosis Fungoides/Sezary Syndrome
- Stage III Small Lymphocytic 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 Hodgkin Lymphoma
- Stage IV Adult Immunoblastic Large Cell Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Stage IV Childhood Anaplastic Large Cell Lymphoma
- Stage IV Childhood Hodgkin 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
- Waldenström Macroglobulinemia
- Congenital Abnormalities
- Anemia
- Anemia, Refractory
- Anemia, Refractory, with Excess of Blasts
- Blast Crisis
- Neoplasms
- Hodgkin Disease
- Immunoblastic Lymphadenopathy
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Hairy 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, Myelomonocytic, Acute
- Leukemia, Myelomonocytic, Chronic
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphomatoid Granulomatosis
- Waldenstrom Macroglobulinemia
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Mycoses
- Mycosis Fungoides
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Sezary Syndrome
- Lymphoma, B-Cell
- Lymphoma, Large-Cell, Immunoblastic
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, Large-Cell, Anaplastic
- Lymphoma, B-Cell, Marginal Zone
- Lymphoma, Extranodal NK-T-Cell
- Anemia, Aplastic
- Lymphoma, Mantle-Cell
- Leukemia, Myelomonocytic, Juvenile
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| LDS Hospital | Salt Lake City, Utah 84143 |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
| VA Puget Sound Health Care System | Seattle, Washington 98101 |
| Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
| Colorado Blood Cancer Institute | Denver, Colorado 80218 |
