Donor Lymphocyte Infusion After Stem Cell Transplant in Treating Patients With Haematological Cancers | Recruiting
Donor Lymphocyte Infusion After Stem Cell Transplant in Treating Patients With Haematological Cancers
Trial Source

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Health Conditions
  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Myeloma
  • Myelodysplastic Syndrome
Ka Man Condne, BSc, MSc
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Primary Contact Details
Recruitment Status
Primary Trial ID Number
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.
Research Details
  • OBJECTIVES: 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 Leukaemia & Lymphoma Research (LLR)
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Other : CD4 DLI, Other : No DLI

Study Arm Groups : CD4 DLI, No DLI

Intervention Type
See Interventions above
Primary Outcome Measures
  • Progression-free survival at 1 year post-transplant; during the study and end of study
Secondary Outcome Measures
  • Proportion of patients attaining multi-lineage full donor chimerism in peripheral blood; End of study; Incidence of infection requiring inpatient treatment; during the study and end of study; Rate of reconstitution of T-cell subsets and viral-specific immunity; End of study; Cumulative incidence of non-relapse mortality at 1 year; End of study; Overall survival and non-relapse mortality; End of study; Incidence, grade, or pattern of graft-versus-host disease; during the study and end of study
Sorry, this information is not available
Result Reports
This is available on the website
Age Range
18 Years - 69 Years
Who Can Participate
Number of Participants
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Bristol Royal Hospital
Southampton General Hospital
Beatson West of Scotland Cancer Centre
Glasgow, Scotland
Trial Contact(s)
Primary Trial Contact
Ka Man Condne, BSc, MSc
Other Trial Contacts
Haematology Trials Group
Countries Recruiting
United Kingdom
Scientific Title
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
EudraCT Number
Not available for this trial
    Sorry, this information is not available
Other Study ID Numbers
University College, London
Key Dates

Recruitment Start Date

Nov 2011

Recruitment End Date

Nov 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

11 Nov 2010

Last Updated

04 Dec 2014