Cyclophosphamide + Bortezomib + Abatacept for Graft-versus-Host Disease

Recruiting at1 trial location

Overseen by A. Samer Al-Homsi, MD, MBA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Northwell Health

No Placebo Group

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing three new treatments to prevent a complication called GvHD in adults with blood cancers receiving stem cell transplants. It targets patients at high risk of GvHD due to their transplant type. The treatments work by calming the immune system to prevent it from attacking the body.

Research Team

A. Samer Al-Homsi, MD, MBA

Principal Investigator

Northwell Health

Eligibility Criteria

Adults with blood cancers eligible for a stem cell transplant from a matched donor can join. They must have good organ function, no severe infections, and be willing to follow the study plan. Pregnant women, those with recent heart issues or another cancer within 3 years (with some exceptions), or who cannot consent are excluded.

Inclusion Criteria

Total bilirubin <2 x the upper limit of normal (except for Gilbert's syndrome)

I do not have any worsening infections.

Creatinine clearance >50 mL/min/1.72m2

Exclusion Criteria

Inability to provide informed consent.

Prisoners

Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.

Treatment Details

Interventions

• Abatacept (Immunomodulator)
• Bortezomib (Proteasome Inhibitor)
• Cyclophosphamide (Alkylating agents)

Trial Overview The trial tests high-dose Cyclophosphamide, Bortezomib, and Abatacept as preventatives for Graft-versus-Host Disease after allogeneic HSCT in adults. It's a phase I-II study assessing the safety and effectiveness of these drugs post-transplant.

Participant Groups

Group I: Participants with hematological malignancies Experimental Treatment 3 Interventions

Participants undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will receive a combination of cyclophosphamide, known commercially as Cytoxan®, abatacept, known as Orecia® and bortezomib commercially known as Velcade®, to reduce the rate of graft-versus-host disease (GvHD). These medications will be given for GvHD prevention during the transplant process.

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

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Michael Dowling

Northwell Health

Chief Executive Officer since 2002

Bachelor's and Master's degrees from University College Cork, Ireland

Dr. David Battinelli

Northwell Health

Chief Medical Officer since 2022

MD from Georgetown University School of Medicine

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD