Donor Lymphocyte Infusion After Stem Cell Transplant in Treating Patients With Haematological Can… (NCT01240525) | Clinical Trial Compass
UnknownPhase 2
Donor Lymphocyte Infusion After Stem Cell Transplant in Treating Patients With Haematological Cancers
United Kingdom114 participantsStarted 2011-11
Plain-language summary
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.
Who can participate
Age range18 Years – 69 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Progression-free survival at 1 year post-transplant