Non Hodgkin Lymphoma Clinical Trial
Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant
Summary
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.
Full Description
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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Buffalo New York, 14263, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.