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

NCT00775632 | Completed Phase 2 DMC

• 1 other identifier: UHN REB 07-0436C
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Versus Host Disease; Bone Marrow Transplantation

Keywords

Graft Versus Host Disease; Alemtuzumab; Campath; Bone Marrow Transplants

Outcome Measures

Primary Outcomes (1)

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

  12 months from the date of transplant

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Drug: mycophenolate or cyclosporine and methotrexate

Cyclosporine and Campath

EXPERIMENTAL

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

Drug: Alemtuzumab

Interventions

Alemtuzumab DRUG

A new GVHD prevention strategy will be tested against established GVHD prophylaxis in patients undergoing matched sibling donor transplant using peripheral blood stem cells.

Cyclosporine and Campath

mycophenolate or cyclosporine and methotrexate DRUG

One of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate

Standard of Care

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Bayer: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Alemtuzumab; Mycophenolic Acid; Cyclosporine; Methotrexate

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Vikas Gupta, MD

  University Heath Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

CA (1)