Cyclophosphamide + Abatacept for Graft-versus-Host Disease

Recruiting in Palo Alto (17 mi)

Overseen by Divya Koura, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dimitrios Tzachanis, MD PhD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate whether the combination of cyclophosphamide and abatacept versus the treatment used in standard of care will reduce the incidence of moderate and severe chronic graft-versus-host disease (GVHD) following hematopoietic stem cell transplantation. GVHD occurs when the cells from your donor (the graft) see your body's cells (the host) as different and attack them.

Research Team

Divya Koura, MD

Principal Investigator

University of California, San Diego

Dimitrios Tzachanis, MD PhD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for people with high-risk blood cancers needing a stem cell transplant and who have a perfectly matched or half-matched donor. They should not be pregnant, breastfeeding, or on other experimental drugs recently. People with active cancer relapse, short life expectancy, certain leukemia types in early stages, or uncontrolled infections and heart problems can't join.

Inclusion Criteria

Creatinine clearance > 40

I have a high-risk blood cancer needing a stem cell transplant.

My liver is working well.

Exclusion Criteria

My blood cancer can be treated with options other than a transplant.

I cannot find a perfectly matched or half-matched donor for a transplant.

My cancer has come back after treatment.

Treatment Details

Interventions

• Abatacept (Immunomodulator)
• Cyclophosphamide (Immunosuppressant)

Trial Overview The study compares the effectiveness of Cyclophosphamide and Abatacept combination to standard treatments in preventing severe chronic graft-versus-host disease after stem cell transplantation. This condition happens when transplanted cells attack the patient's own body cells.

Participant Groups

Group I: Cyclophosphamide and abatacept Experimental Treatment 2 Interventions

The GVHD prophylaxis regimen on the experimental arm will consist of high dose Cyclophosphamide on Days +3 and +4 followed by abatacept for 6 months. Abatacept at a dose of 10mg/kg will be administered on days +5, +14 and +28, +56, +84, +112, +140, +168

Group II: methotrexate and tacrolimus Active Control 2 Interventions

The GVHD prophylaxis regimen on the standard of care arm will consist of methotrexate on Days +1,+3, +6 and +11 and tacrolimus

Abatacept is already approved in Canada, Japan for the following indications:

Approved in Canada as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis

Approved in Japan as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis

Who Is Running the Clinical Trial?

Dimitrios Tzachanis, MD PhD

Lead Sponsor

Trials

1

Recruited

40+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania