N/A
N=39
Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant
Leukemia · Lymphoma · Multiple Myeloma and Plasma Cell Neoplasm · Myelodysplastic Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00534118 ↗Enrolled (actual)
39
Serious AEs
63.0%
Results posted
Aug 2020
Primary outcome: Primary: Complete Remission Rate — 8; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- donor lymphocytes (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Remission Rate |
8; 6 | — |
| PRIMARY Duration of Complete Response in Months (Maximum 12) |
10.1; 9 | — |
| SECONDARY Acute Graft-versus-host Disease |
0; 4 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00534118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.