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Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants

Primary Purpose

Graft Versus Host Disease, Bone Marrow Transplantation

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Alemtuzumab
mycophenolate or cyclosporine and methotrexate
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring Graft Versus Host Disease, Alemtuzumab, Campath, Bone Marrow Transplants

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of a hematological malignancy
  • Peripheral blood as source of stem cells
  • Able to give informed consent
  • Availability of 6/6 matched sibling donor
  • Fit for transplant using a conventional or reduced intensity approach

Exclusion Criteria:

  • AST/ALT >3 x IULN at the time of transplant
  • Serum creatinine > 1.5 x IULN at the time of transplant
  • Prior allogeneic transplant
  • Syngeneic donor
  • Active uncontrolled infection
  • HIV positive
  • Pregnancy at the time of BMT

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Cyclosporine and Campath

Arm Description

The current standard of care for GVHD prophylaxis at Princess Margaret Hospital is cyclosporine and Mycophenolate or cyclosporine and methotrexate.

The efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD.

Outcomes

Primary Outcome Measures

Chronic extensive GVHD at 1-year (yes vs. no)

Secondary Outcome Measures

Full Information

First Posted
October 16, 2008
Last Updated
June 21, 2016
Sponsor
University Health Network, Toronto
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00775632
Brief Title
Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants
Official Title
A Phase II Randomized Study Comparing Low Dose Alemtuzumab and Cyclosporine With Standard of Care for the Prevention of Chronic Extensive GVHD for Patients Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Graft versus host disease (GVHD) is one of the common complications after stem cell transplant. This is a complication, which happens when the new stem cells from the donor attack other cells in the body of the transplant recipient. Recently, an antibody (protein) called alemtuzumab or Campath has been found to be effective in the prevention of Graft vs. Host Disease. Previous studies have shown a low risk of GVHD with alemtuzumab, however the risk of disease recurrence was high. Previous studies have used a high dose of alemtuzumab. The purpose of this study is: To find if by lowering the dose of alemtuzumab, can serious GVHD be prevented without increasing the risk of relapse (your condition getting worse). To find whether low dose of alemtuzumab in combination with cyclosporine can prevent GVHD more effectively when compared to current standard of care and does not increase the risk of recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Bone Marrow Transplantation
Keywords
Graft Versus Host Disease, Alemtuzumab, Campath, Bone Marrow Transplants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
The current standard of care for GVHD prophylaxis at Princess Margaret Hospital is cyclosporine and Mycophenolate or cyclosporine and methotrexate.
Arm Title
Cyclosporine and Campath
Arm Type
Experimental
Arm Description
The efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD.
Intervention Type
Drug
Intervention Name(s)
Alemtuzumab
Intervention Description
A new GVHD prevention strategy will be tested against established GVHD prophylaxis in patients undergoing matched sibling donor transplant using peripheral blood stem cells.
Intervention Type
Drug
Intervention Name(s)
mycophenolate or cyclosporine and methotrexate
Intervention Description
One of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate
Primary Outcome Measure Information:
Title
Chronic extensive GVHD at 1-year (yes vs. no)
Time Frame
12 months from the date of transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of a hematological malignancy Peripheral blood as source of stem cells Able to give informed consent Availability of 6/6 matched sibling donor Fit for transplant using a conventional or reduced intensity approach Exclusion Criteria: AST/ALT >3 x IULN at the time of transplant Serum creatinine > 1.5 x IULN at the time of transplant Prior allogeneic transplant Syngeneic donor Active uncontrolled infection HIV positive Pregnancy at the time of BMT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vikas Gupta, MD
Organizational Affiliation
University Heath Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants

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