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Completed

NCT Number: NCT02504047

Use of Haploidentical Related Donors for Patients Without Matched Sibling, Unrelated Donor or Cord Blood Units

The administration of high-dose chemotherapy followed by the infusion of blood or bone marrow stem cells (stem cell transplantation) from a matched donor has become standard treatment for patients with high-risk or relapsed hematological cancers. Currently, donors are found for approximately 80% of people who require such treatment, although the chance of finding a donor is much lower in some ethnic communities. In the current study the investigators will offer patients requiring transplantation, but for whom well matched donors cannot be identified either from within the family or on the donor registry, a transplant from a half-matched (haploidentical) family member. A myeloablative conditioning regimen and un-manipulated peripheral blood stem cells will be used. Post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil will be used to prevent graft versus host disease (GVHD). The primary outcome measure will be 6 month survival free from graft failure, relapse and grade 3-4 acute GVHD. Other outcomes of interest will include the frequency of Cytomegalovirus (CMV) or Epstein-Barr Virus (EBV) requiring treatment, overall survival and progression-free survival.

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Key information

Conditions

Hematologic Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Center / Tom Baker Cancer Center, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A hematological malignancy such as acute leukemia or myelodysplastic syndrome requiring hematopoietic stem cell transplantation.
  • A haploidentical family member willing to donate.
  • Suitable performance status, organ function (as defined locally) and disease status for transplantation.
  • Patients with acute leukemia must be in morphological complete remission. Patients with chronic myelogenous leukemia must be in chronic phase and those with lymphoma must have chemosensitive disease (at least partial remission to most recent chemotherapy regimen).
  • Given written, informed consent to participate in a clinical trial.

Exclusion criteria

  • An 8/8 matched sibling donor or matched unrelated donor (based on high-resolution typing as appropriate), available within a time frame acceptable to the treating physician
  • Patients with an available single allele or single antigen mismatched donor (7/8 or 9/10) or available cord blood donor can be included at the discretion of the treating team, according to local institutional practice.
  • Prior allogeneic transplant
  • Any exclusion criteria for allogeneic stem cell transplant, as defined by the program. Examples typically include pregnancy, significant comorbidity, and active uncontrolled infection.

Treatment and study plan

T-Cell replete haplo-transplant

Procedure

Infusion of haploidentical related donor peripheral blood stem cells following myeloablative conditioning (fludarabine 200 mg/m2, busulfan 12.8 mg/kg and total body irradiation (TBI) 400 centigray -or- fludarabine 200 mg/m2, busulfan 9.6 mg/kg). GVHD prophylaxis will be with cyclophosphamide 50 mg/kg/day x 2 on days 3 & 4, mycophenolate mofetil 1 gm p.o. bid days 5 - 35 and tacrolimus (5-15 ug/ml) days 5 - 100.

Primary outcomes

  1. Six month survival, free from relapse, graft failure and grade III/IV acute GVHD

    Time frame: Six months

Secondary outcomes

  1. Incidence of Grade III/IV Acute Graft Versus Host Disease

    Time frame: Six months

  2. Incidence of Chronic Extensive Graft Versus Host Disease

    Time frame: One year

  3. Cumulative incidence of non-relapse mortality at 1 year

    Time frame: One year

  4. Graft failure rate (ANC < 0.5 and low donor chimerism)

    Time frame: Six months

  5. Overall and Disease Free Survival

    Time frame: One year

  6. Relapse Rate

    Time frame: One year

  7. Patients remaining on immune suppression at 1 year

    Time frame: One year

  8. Incidence of CMV and EBV reactivation requiring treatment

    Time frame: One year

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • The Canadian Blood and Marrow Transplant Group

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2015
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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