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Phase 2 N=77 Treatment

Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Accelerated Phase Chronic Myelogenous Leukemia · Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities · Adult Acute Myeloid Leukemia With Del(5q) · Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) · Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

Enrolled (actual)
77
Serious AEs
33.3%
Results posted
Aug 2019
Primary outcome: Primary: Percentage of Patients Who Are Able to Receive at Least One DLI Treatment — 36 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
therapeutic allogeneic lymphocytes (Biological); laboratory biomarker analysis (Other)
Age
Pediatric, Adult, Older Adult · 14+ yrs
Sex
All
Sponsor
University of Chicago
Primary completion
Aug 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
36
SECONDARY
Progression Free Survival (PFS)
43
SECONDARY
Overall Survival (OS)
59.7
SECONDARY
Rate of Acute GVHD (aGVHD) With Any Grade
41.8; 41.8
SECONDARY
Rate of Chronic GVHD (cGVHD)
26.6; 26.6
SECONDARY
Treatment-related Mortality
12.1

Summary

This pilot phase II trial studies how well giving donor T cells after donor stem cell transplant works in treating patients with hematologic malignancies. In a donor stem cell transplant, the donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect.

Eligibility Criteria

Inclusion Criteria

  • INCLUSION CRITERIA PRIOR TO TRANSPLANT:
  • The clinical trial will be offered to all high risk (defined 3 below) patients with hematologic malignancies who require stem cell transplants as part of their standard of care using matched related or unrelated donors
  • Patients with high risk myeloid or lymphoid malignancies at stem cell transplant following American Society for Blood and Marrow Transplantation (ASBMT) criteria, including but not limited to conditions listed; these criteria apply BEFORE cyto-reductive therapy given within 28 days of planned conditioning:
  • Refractory acute myelogenous or lymphoid leukemia
  • Relapsed acute myelogenous or lymphoid leukemia
  • Myelodysplastic syndromes with 5% or more blasts
  • Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase
  • Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant
  • High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen
  • DONORS: Matched related or unrelated donor stem cell transplant (SCT) matched at human leukocyte antigen (HLA) A- B, C, and DRB1 by molecular methods; 7 of 8 matched donor acceptable for related donors
  • T-cell depletion with anti-thymocyte globulin (ATG) (rabbit or horse) or at least 30 mg of alemtuzumab total in the conditioning regimen
  • Immune suppression; planned post-transplant immune suppression should include tacrolimus or cyclosporin monotherapy (i.e., calcineurin inhibitor or CN) for alemtuzumab regimens and a second immune suppressant for ATG treated patients; other agents may be used if CN intolerance or toxicity occurs post-transplant
  • Zubrod performance status (PS) 0-2 or equivalent Karnofsky PS
  • Eligible for allogeneic transplant in the treating physicians' judgment and by institutional standards
  • ELIGIBILITY TO RECEIVE DLI POST-TRANSPLANT:
  • Donor lymphocytes available or able to be collected
  • No evidence of disease by standard morphology; minimal residual disease or molecular evidence of disease will not exclude
  • Absolute neutrophil count >= 500/μl
  • Platelet count >= 20, 000/μl without transfusion for 7 days
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) = = 2.0 mg/dL
  • SGOT and SGPT >= 5 x ULN; liver biopsy preferred for such patients
  • Bilirubin >= 3 x ULN (unless Gilbert's syndrome)
  • Diffusing capacity of the lung for carbon monoxide (DLCO) < 50% corrected for hemoglobin
  • Left ventricular ejection fraction or shortening fraction < 40%
  • Unlikely to be able to procure additional donor lymphocytes
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01839916). 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.

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