Clinical trial · Interventional
Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia
A Study to Determine the Safety and Efficacy of Using CD8-High Density Microparticles (CD8-HDM) to Deplete CD8+ Cells From Donor Lymphocyte Infusion in Order to Reduce Graft-versus-Host Disease (GvHD) Without Compromising an Anti-Leukemia Effect in Patients With Chronic Myeloid Leukemia Given HLA-Identical Sibling Peripheral Blood Stem Cell Transplants After Non-Myeloablative Conditioning
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study never opened
Summary
Brief summary (as posted)
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's normal tissues. Donor lymphocytes that have been treated in the laboratory may prevent this from happening. PURPOSE: Randomized phase II trial to study the effectiveness of donor lymphocytes to prevent graft-versus-host disease in patients who are undergoing peripheral stem cell transplantation for chronic myeloid leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| in vitro-treated peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven chronic myeloid leukemia (CML) in first chronic phase or with cytogenetic but not hematologic evidence of acceleration (clonal evolution) Availability of 6 antigen (A, B, and DR loci) HLA identical sibling donor Eligible for randomization to donor lymphocyte infusion (DLI) if: Residual Ph+ cells by cytogenetics or FISH or hematologic or clinical evidence of CML AND No graft versus host disease requiring immunosuppressive therapy within the past 2 weeks AND Evidence of donor hematopoiesis after completion of transplantation Ineligible for randomization to DLI if: Blast transformation of CML OR Prior interferon alfa for relapse after completion of transplantation PATIENT CHARACTERISTICS: Age: 50 to 70 Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 3 mg/dL Renal: Creatinine less than 2 mg/dL Cardiovascular: Cardiac ejection fraction greater than 40% Pulmonary: DLCO greater than 45% predicted Other: No active infection Not pregnant Negative pregnancy test No hypersensitivity to nickel No hypersensitivity to mouse proteins Human antimouse antibody positivity allowed if no allergic history HIV negative HTLV antibody negative PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent hematopoietic growth factors other than filgrastim (G-CSF) No other biologic therapy (e.g., interferon alfa) for 6 months after completion of study therapy Chemotherapy: No other chemotherapy for 6 months after completion of study therapy Concurrent hydroxyurea allowed for CML relapse Endocrine therapy: Concurrent methylprednisolone allowed if grade II or worse GVHD develops Radiotherapy: No radiotherapy for 6 months after completion of study therapy Surgery: Not specified
References
Publications (0)
Data not yet available