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

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

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Trial Information

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



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


- 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

Inclusion Criteria


- 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

- Residual or progressive disease

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

- 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

- 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

- 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


- 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


- See Disease Characteristics

Type of Study:


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:


Principal Investigator

Philip L. McCarthy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Institutional Review Board

Study ID:




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



Roswell Park Cancer Institute Buffalo, New York  14263