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 range
18 Years – 69 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival at 1 year post-transplant