or
forgot password

Cellular Infusions in Patients With Recurrent or Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplant


N/A
N/A
76 Years
Open (Enrolling)
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

Thank you

Trial Information

Cellular Infusions in Patients With Recurrent or Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplant


OBJECTIVES:

Primary

- Determine if the complete response rate exceeds 10% in patients with recurrent or
persistent hematologic malignancies treated with donor lymphocyte infusion.

Secondary

- Estimate the complete response rate in these patients.

- Assess the toxicity of donor lymphocyte infusion in these patients.

OUTLINE: Patients receive up to four donor lymphocyte infusions at least 1 month apart in
the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host
disease.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Has undergone allogeneic stem cell transplantation (ASCT) for hematologic malignancy
at least 30 days ago

- No failure to engraft following transplant

- No active acute or chronic graft-versus-host disease (GVHD)

- Minimal GVHD allowed

- Persistent or relapsed disease after ASCT, including 1 of the following:

- Chronic myelogenous leukemia (CML), meeting any of the following criteria:

- Molecular relapse (may be treated with imatinib mesylate after transplant),
as defined by any of the following:

- ASCT was non-T-cell depleted, a negative bcr/abl was documented by PCR
post-transplant, and bcr/abl is now detectable by 2 consecutive PCR
determinations > 30 days apart

- ASCT was non-T-cell depleted and bcr/abl is detectable by PCR at any
time after day 180 post-transplant

- Cytogenetic relapse after 3-6 months of imatinib mesylate

- Relapsed chronic phase, accelerated phase, or blastic phase CML after 3-6
months of imatinib mesylate

- Must currently be in chronic phase or accelerated phase CML only

- Patients with blastic phase CML must attain a second chronic phase

- Acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic
syndromes, meeting any of the following criteria:

- Molecular relapse, as evidenced by < 5% blasts in the bone marrow and the
patient's leukemia-specific molecular abnormality detectable by PCR

- Cytogenetic relapse, as evidenced by < 5% blasts in the bone marrow and the
patient's leukemia-specific chromosome abnormality detectable by standard
cytogenetics at any time after day 60 post-transplant

- Hematologic relapse, as evidenced by > 20% blasts in bone marrow or soft
tissue recurrence

- Must be treated with chemotherapy after transplant, but before study
donor lymphocyte infusion (DLI)

- Multiple myeloma

- Relapsed disease or recurrence of M-protein after thalidomide or other
salvage treatment

- Prior post-transplant documentation of disappearance of M-protein by
immunofixation

- Residual or progressive disease

- Rising M-protein level at any time post-transplant (measured at 3-month
intervals)

- Original M-protein detectable at 6 months post-transplant

- Immune protein electrophoresis (IPEP) is required to show that M-component
is the same on day 60 post-transplant as pre-transplant

- Residual (> 5%) plasma cells in bone marrow

- Relapsed non-Hodgkin lymphoma or Hodgkin lymphoma

- Relapse or progression of disease must be evidenced within 3 months prior
to donor lymphocyte infusion by physical exam, radiographic studies, or
molecular studies

- Tumor should be re-biopsied to determine histology

- If Epstein-Barr virus (EBV) lymphoma is suspected, peripheral blood must be
assayed for EBV genome (i.e., EBV DNA testing by PCR) within the past 30
days

- EBV infection with associated pancytopenia

- Persistent or refractory pancytopenia with EBV genome detected by PCR in
the peripheral blood

- Refractory pancytopenia is defined as pancytopenia that is poorly
responsive to growth factors and/or transfusions

- EBV lymphoproliferative disorder

- Clonal lymphadenopathy that is refractory to standard therapy with
acyclovir and immunoglobulin (DLI may be given with rituximab)

- Not a candidate for repeat ASCT

- Chimerism status is not required for determining eligibility for DLI

- Patients eligible for allogeneic ASCT, but for whom DLI is offered as the first
option, should have full donor chimerism at relapse or after therapy for relapsed
disease

- Patients with relapsed underlying disease after transplant who achieved remission
after chemotherapy are allowed

- No CNS recurrence that is not cleared by standard chemotherapy

- CNS remission status must be maintained for 2 weeks

- Original hematopoietic progenitor stem cell donor must be available for cell donation

- No syngeneic donors

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- Life expectancy ≥ 8 weeks

- Creatinine < 3 mg/dL

- ABO/Rh and CMV IgG/IgM status known

- No HIV1 and HIV2 antibody

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months (males) or
6 months (females) after completion of study treatment

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine if response rate exceeds 10%

Outcome Time Frame:

Every 2 weeks

Safety Issue:

No

Principal Investigator

Philip L. McCarthy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000564827

NCT ID:

NCT00534118

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • accelerated phase chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • childhood chronic myelogenous leukemia
  • previously treated myelodysplastic syndromes
  • recurrent adult acute lymphoblastic leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • 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)
  • recurrent adult acute myeloid leukemia
  • recurrent childhood acute myeloid leukemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
  • recurrent adult Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • 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 immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic 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 small lymphocytic lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • Waldenstrom macroglobulinemia
  • recurrent childhood grade III lymphomatoid granulomatosis
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • childhood diffuse large cell lymphoma
  • childhood immunoblastic large cell lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • de novo myelodysplastic syndromes
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • splenic marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • cutaneous B-cell non-Hodgkin lymphoma
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263