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

Hematologic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504047
• Other study ID #: 26110
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: February 2019

Study information

• Verified date: April 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Foothills Medical Center / Tom Baker Cancer Center	Calgary	Alberta
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Health Sciences Center	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	The Canadian Blood and Marrow Transplant Group

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six month survival, free from relapse, graft failure and grade III/IV acute GVHD		Six months
Secondary	Incidence of Grade III/IV Acute Graft Versus Host Disease		Six months
Secondary	Incidence of Chronic Extensive Graft Versus Host Disease		One year
Secondary	Cumulative incidence of non-relapse mortality at 1 year		One year
Secondary	Graft failure rate (ANC < 0.5 and low donor chimerism)		Six months
Secondary	Overall and Disease Free Survival		One year
Secondary	Relapse Rate		One year
Secondary	Patients remaining on immune suppression at 1 year		One year
Secondary	Incidence of CMV and EBV reactivation requiring treatment		One year