Clinical trial · Interventional
Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Pilot Study of Prophylactic Dose-Escalation Donor Lymphocyte Infusion After T Cell Depleted Allogeneic Stem Cell Transplant in High Risk Patients With Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (64)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Del(5q) | Acute Myeloid Leukemia with del(5q) | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (DLI)
- description
- Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: therapeutic allogeneic lymphocytes
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
- timeFrame
- Up to 2 years
Secondary outcomes (5)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 2 years
- description
- Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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) =\< 5 x upper limit of normal (ULN) * Bilirubin =\< 3 x ULN * No evidence of grade II or higher acute GVHD or chronic GVHD at initiation of first DLI * No systemic corticosteroids or immunosuppressive drugs (topical acceptable); replacement steroids for adrenal insufficiency are not excluded Exclusion Criteria: * EXCLUSION CRITERIA PRIOR TO TRANSPLANT: * Pregnant or lactating females * Hepatitis B with positive viral load prior to transplant conditioning or hepatitis C virus * Human immune deficiency virus * Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent * Creatinine \>= 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
References
Publications (0)
Data not yet available