|
Health Condition(s) or Problem
|
Graft Versus Host Disease; Leukemia; Lymphoma; Myeloma; Myelodysplastic Syndrome
|
|
Lay 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.
(from ClinicalTrials.gov)
|
|
Who can enter the trial
|
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 the
fludarabine-melphalan-alemtuzumab conditioning regimen line therapy
- 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
|
|
Who cannot enter the trial
|
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 the
fludarabine-melphalan-alemtuzumab conditioning regimen line therapy
- 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 will happen
|
Other; CD4 DLI; Patients will receive CD4 DLI between day 70 to 100 post transplant; CD4 DLI; Other; No DLI; Patients will not receive DLI as trial treatment; No DLI
|
|
Primary aim
|
Progression-free survival at 1 year post-transplant
|
|
Secondary Aim
|
Proportion of patients attaining multi-lineage full donor chimerism in peripheral blood; End of study; No; Incidence of infection requiring inpatient treatment; during the study and end of study; Yes; Rate of reconstitution of T-cell subsets and viral-specific immunity; End of study; No; Cumulative incidence of non-relapse mortality at 1 year; End of study; No; Overall survival and non-relapse mortality; End of study; No; Incidence, grade, or pattern of graft-versus-host disease; during the study and end of study; Yes
|
|
Participant Information Sheet
|
Sorry, not currently available
|
|
Website
|
http://www.ctc.ucl.ac.uk/TrialDetails.aspx?TrialID=54
|
|
Recruitment Status
|
Recruiting
|
|
Nation
|
England, Scotland
|
|
Location
|
London, Birmingham, Bristol, Cambridge, Glasgow, Leeds, Leicester, Manchester, Nottingham, Sheffield, Southampton
|