Mode
Text Size
Log in / Sign up
N/A N=39 Treatment

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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search