Phase 2
N=77
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)
Bottom Line
View on ClinicalTrials.gov: NCT01839916 ↗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
| Outcome | Result | p-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
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.