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.

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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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

39

Study ID:

NCT00534118

Recruitment Status:

Completed

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

39

Study ID:

NCT00534118

Recruitment Status:

Completed

Sponsor:


Roswell Park Cancer Institute

How clear is this clinincal trial information?

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