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

NCT ID: NCT02504047

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2019-02-28

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.

Conditions

Hematologic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

T-Cell replete haplo-transplant

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Canadian Blood and Marrow Transplant Group

NETWORK

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Andrew Daly

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Daly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Kristjan Paulson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Foothills Medical Center / Tom Baker Cancer Center

Calgary, Alberta, Canada

Health Sciences Center

Winnipeg, Manitoba, Canada

Ottawa General Hospital

Ottawa, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

26110

Identifier Type: -

Identifier Source: org_study_id