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

Primary Purpose

Hematologic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
T-Cell replete haplo-transplant
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Neoplasms focused on measuring Hematopoietic Stem Cell Transplantation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Foothills Medical Center / Tom Baker Cancer Center
  • Health Sciences Center
  • Ottawa General Hospital
  • McGill University Health Centre
  • Royal University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

T-Cell replete haplo-transplant

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Grade III/IV Acute Graft Versus Host Disease
Incidence of Chronic Extensive Graft Versus Host Disease
Cumulative incidence of non-relapse mortality at 1 year
Graft failure rate (ANC < 0.5 and low donor chimerism)
Overall and Disease Free Survival
Relapse Rate
Patients remaining on immune suppression at 1 year
Incidence of CMV and EBV reactivation requiring treatment

Full Information

First Posted
July 17, 2015
Last Updated
April 15, 2019
Sponsor
University of Calgary
Collaborators
The Canadian Blood and Marrow Transplant Group
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1. Study Identification

Unique Protocol Identification Number
NCT02504047
Brief Title
Use of Haploidentical Related Donors for Patients Without Matched Sibling, Unrelated Donor or Cord Blood Units
Official Title
Use of Haploidentical Related Donors for Patients Without Matched Sibling, Unrelated Donor or Cord Blood Units
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
The Canadian Blood and Marrow Transplant Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms
Keywords
Hematopoietic Stem Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T-Cell replete haplo-transplant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
T-Cell replete haplo-transplant
Intervention Description
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 Measure Information:
Title
Six month survival, free from relapse, graft failure and grade III/IV acute GVHD
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Incidence of Grade III/IV Acute Graft Versus Host Disease
Time Frame
Six months
Title
Incidence of Chronic Extensive Graft Versus Host Disease
Time Frame
One year
Title
Cumulative incidence of non-relapse mortality at 1 year
Time Frame
One year
Title
Graft failure rate (ANC < 0.5 and low donor chimerism)
Time Frame
Six months
Title
Overall and Disease Free Survival
Time Frame
One year
Title
Relapse Rate
Time Frame
One year
Title
Patients remaining on immune suppression at 1 year
Time Frame
One year
Title
Incidence of CMV and EBV reactivation requiring treatment
Time Frame
One year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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 Any exclusion criteria for allogeneic stem cell transplant, as defined by the program. Examples typically include pregnancy, significant comorbidity, and active uncontrolled infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Daly, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristjan Paulson, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Center / Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Health Sciences Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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