Donor Lymphocyte Infusion After Stem Cell Transplant in Treating Patients With Haematological Cancers
NCT ID: NCT01240525
Last Updated: 2019-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
114 participants
INTERVENTIONAL
2011-11-30
2019-11-30
Brief Summary
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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.
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Detailed Description
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Primary
* To evaluate the effect of prophylactic transfer of donor CD4 cells after T-cell depleted reduced-intensity HLA-identical sibling transplantation upon the risk of relapse or progression in patients with haematological cancers (e.g. NHL, HL, CLL/PLL, PCM, AML, ALL, MDS or CMML depending on the disease status).
Secondary
* To evaluate the effect of prophylactic transfer of donor CD4 cells upon the risk of graft-versus-host disease (GvHD) in these patients.
* To evaluate the effect of prophylactic transfer of donor CD4 cells upon the rates of conversion to full donor chimerism in peripheral blood in these patients.
* To determine the effect of prophylactic transfer of donor CD4 cells upon immune reconstitution in these patients.
* To evaluate the impact of prophylactic transfer of donor CD4 cells upon non-relapse mortality and overall survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV, melphalan IV, and alemtuzumab IV as reduced intensity conditioning for T-cell depletion followed by a reduced-intensity HLA-identical sibling stem cell transplantation on day 0. Withdrawal of cyclosporine immunosuppression therapy commence at day 40 with tapering over a period of 3-4 weeks, according to the discretion of the PI. Patients are reassessed between day 70-90 post-transplantation. Patients with stable engraftment, no significant graft-versus-host disease, and no early relapse or progression are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive an allogeneic CD4 donor lymphocyte infusion (DLI) at a dose of 1 x10\^6 CD4 cells/kg body weight without any other medication once between day 100-120.
* Arm II: Patients receive no further treatment.
Patients undergo blood sample collection for chimerism studies and translational research.
After completion of study treatment, patients are followed up periodically for 1 years and then annually.
Peer Reviewed and Funded or Endorsed by Bloodwise.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CD4 DLI
Patients will receive trial product manipulated CD4 DLI post transplant as trial treatment.
CD4 DLI
Patients will receive CD4 DLI between day 70 to 115 post transplant
No DLI
Patients will receive no DLI post transplant as trial treatment.
No DLI
Patients will not receive DLI as trial treatment
Interventions
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CD4 DLI
Patients will receive CD4 DLI between day 70 to 115 post transplant
No DLI
Patients will not receive DLI as trial treatment
Eligibility Criteria
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Exclusion Criteria
* 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
18 Years
69 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Ronjon Chakraverty, Professor
Role: PRINCIPAL_INVESTIGATOR
University College Hospital London; UCL Cancer Institute
Locations
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Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
University College Hospital London (UCLH)
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
University Hospitals Southampton
Southampton, , United Kingdom
Countries
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Related Links
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CRUK \& UCL Cancer Trial Centre - coordinating centre
Other Identifiers
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UCL-10/0241
Identifier Type: OTHER
Identifier Source: secondary_id
LRF-09041
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EU-21081
Identifier Type: OTHER
Identifier Source: secondary_id
CRUK-UCL-PROT4
Identifier Type: OTHER
Identifier Source: secondary_id
UCL/10/0241
Identifier Type: -
Identifier Source: org_study_id
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