Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant



Status:Completed
Conditions:Cancer, Blood Cancer, Lymphoma, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any - 76
Updated:11/11/2018
Start Date:October 1, 2003
End Date:July 26, 2018

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

RATIONALE: Giving an infusion of donor lymphocytes may be able to kill cancer cells in
patients with hematologic cancer that has come back after a donor stem cell transplant.

PURPOSE: This clinical trial is studying how well donor lymphocyte infusion works in treating
patients with recurrent or persistent hematologic cancer after donor 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.

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
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