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Status:

UNKNOWN

Donor Lymphocyte Infusion After Stem Cell Transplant in Treating Patients With Haematological Cancers

Lead Sponsor:

University College, London

Conditions:

Graft Versus Host Disease

Leukemia

Eligibility:

All Genders

18-69 years

Phase:

PHASE2

Brief 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 fro...

Detailed Description

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 pro...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2019

    Estimated Enrollment :

    114 Patients enrolled

    Trial Details

    Trial ID

    NCT01240525

    Start Date

    November 1 2011

    End Date

    November 1 2019

    Last Update

    February 12 2019

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    Birmingham Heartlands Hospital

    Birmingham, United Kingdom

    2

    Bristol Royal Hospital for Children

    Bristol, United Kingdom

    3

    Addenbrooke's Hospital

    Cambridge, United Kingdom

    4

    Beatson West of Scotland Cancer Centre

    Glasgow, United Kingdom