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

NCT02504047 | Completed DMC

• 1 other identifier: 26110
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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

Keywords

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

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

  Six months

Secondary Outcomes (8)

• Incidence of Grade III/IV Acute Graft Versus Host Disease

  Six months

• Incidence of Chronic Extensive Graft Versus Host Disease

  One year

• Cumulative incidence of non-relapse mortality at 1 year

  One year

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

  Six months

• Overall and Disease Free Survival

  One year

Study Arms (1)

T-Cell replete haplo-transplant

EXPERIMENTAL

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

Interventions

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.

T-Cell replete haplo-transplant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• The Canadian Blood and Marrow Transplant Group: collaborator

Study Sites (5)

Foothills Medical Center / Tom Baker Cancer Center

Calgary, Alberta, T2N 4N2, Canada

Location

Health Sciences Center

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew Daly, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Kristjan Paulson, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 21, 2015
• Study Start: February 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

CA (5)