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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00775632

Enrollment

Registered

2008-10-20

Start date

2008-10-31

Completion date

2010-09-30

Last updated

2016-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Transplantation, Graft Versus Host Disease

Keywords

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

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.

Interventions

DRUGAlemtuzumab

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

DRUGmycophenolate or cyclosporine and methotrexate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Chronic extensive GVHD at 1-year (yes vs. no)	12 months from the date of transplant

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026