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

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ClinicalTrials.gov Identifier: NCT02504047
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
The Canadian Blood and Marrow Transplant Group
Information provided by (Responsible Party):
Andrew Daly, University of Calgary

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Procedure: T-Cell replete haplo-transplant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Haploidentical Related Donors for Patients Without Matched Sibling, Unrelated Donor or Cord Blood Units
Study Start Date : February 2014
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: T-Cell replete haplo-transplant
Infusion of peripheral blood stem cells from a haploidentical related donor following myeloablative conditioning. Cyclophosphamide, mycophenolate mofetil and tacrolimus will be given for GVHD prophylaxis.
Procedure: T-Cell replete haplo-transplant
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 Outcome Measures :
  1. Six month survival, free from relapse, graft failure and grade III/IV acute GVHD [ Time Frame: Six months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504047


Locations
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Canada, Alberta
Foothills Medical Center / Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
Health Sciences Center
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Calgary
The Canadian Blood and Marrow Transplant Group
Investigators
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Principal Investigator: Andrew Daly, MD University of Calgary
Principal Investigator: Kristjan Paulson, MD University of Manitoba

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Responsible Party: Andrew Daly, MD, University of Calgary
ClinicalTrials.gov Identifier: NCT02504047     History of Changes
Other Study ID Numbers: 26110
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Andrew Daly, University of Calgary:
Hematopoietic Stem Cell Transplantation
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases