Clinical trial · Interventional
Donor Lymphocyte Infusion After Stem Cell Transplant in Treating Patients With Haematological Cancers
Multicenter Randomized Phase II Study to Evaluate the Efficacy of Prophylactic Transfer of CD4 Lymphocytes After T-cell Depleted Reduced Intensity HLA-Identical Sibling Transplantation for Haematological Cancers
- 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)
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. 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) that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving alemtuzumab before transplant and cyclosporine after transplant, may stop this from happening. PURPOSE: This randomized phase II trial is studying donor lymphocyte infusion after stem cell transplant in preventing cancer relapse or cancer progression in patients with follicular lymphoma, small lymphocytic non-Hodgkin lymphoma, or chronic lymphocytic leukemia.
Conditions
Conditions (5)
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 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD4 DLI | Other | — | UNRESOLVED |
| No DLI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- CD4 DLI
- description
- Patients will receive trial product manipulated CD4 DLI post transplant as trial treatment.
- interventionNames
- Other: CD4 DLI
- type
- OTHER
- label
- No DLI
- description
- Patients will receive no DLI post transplant as trial treatment.
- interventionNames
- Other: No DLI
Primary outcomes (1)
- measure
- Progression-free survival at 1 year post-transplant
- timeFrame
- during the study and end of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
At registration (pre-transplant) * Haematological cancer which can be ONE OF the following: * Non-Hodgkin's lymphoma (NHL) in CR or PR * Hodgkin's lymphoma (HL) in CR or PR * Chronic (Pro-)lymphocytic leukaemia (CLL/PLL) in CR or PR * Plasma cell myeloma (PCM) in CR, VGPR or PR * Acute myeloid leukaemia (AML) in CR * Acute lymphoblastic leukaemia (ALL) in CR * Myelodysplastic syndrome (MDS) \< 10% blasts in bone marrow * Chronic myelomonocytic leukaemia (CMML) \< 10% blasts in bone marrow * Have undergone disease reassessment within 8 weeks prior to registration * HLA-identical sibling transplant to be performed using one of the following reduced intensity alemtuzumab-containing conditioning regimens: * Fludarabine-busulphan-alemtuzumab * Fludarabine-melphalan-alemtuzumab * BCNU-etoposide-cytarabine-melphalan (BEAM)-alemtuzumab * CCNU-etoposide-cytarabine-melphalan (LEAM)-alemtuzumab * Aged ≥18 years, and \<70 years * Written informed consent Exclusion Criteria * Women who are pregnant or breast-feeding * Life expectancy of \<8 weeks * Currently taking part in any other interventional clinical research study (involving any IMP, ATMP or cellular therapy) * Organ dysfunction: Creatinine \>200μmol/l, Bilirubin \>50μmol/l, or AST/ALT \> 3x ULN Post-transplant * Active acute GvHD * Prior grade II-IV GvHD * Relapse or progressive disease * Primary or secondary graft failure * Other cellular therapies * Requirement for ongoing immunosuppression
References
Publications (0)
Data not yet available