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OpenTrials
Completed

NCT Number: NCT00775632

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

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.

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Key information

Conditions

Graft Versus Host Disease Bone Marrow Transplantation Graft vs Host Disease Immune System Diseases

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

mycophenolate or cyclosporine and methotrexate

Drug

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

Primary outcomes

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

    Time frame: 12 months from the date of transplant

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 20, 2008
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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