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Immunomodulator

Cyclophosphamide + Abatacept for Graft-versus-Host Disease

Phase 2

Waitlist Available

Led By Divya Koura, MD

Research Sponsored by Dimitrios Tzachanis, MD PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High risk hematologic malignancy justifying the need for an allogeneic hematopoetic stem cell transplantation: AML, ALL, CML in accelerated or blast phase, MDS/MPN, NHL, Hodgkin lymphoma, and multiple myeloma

Normal cardiac function (EF > 50%)

Must not have

Patients with hematologic malignancies for which transplant is not the only curative option, such as AML with good or intermediate cytogenetics or molecular markers in CR1 or CML in chronic phase

Inability to identify an 10/10 HLA-Matched Donor (related or unrelated) or a haploidentical donor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two different treatments for GVHD.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune system reactions like inflammation, infection risks due to weakened defenses, liver issues from medication toxicity, nausea from chemotherapy drugs like Methotrexate and Cyclophosphamide, as well as potential heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My heart functions normally.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My cancer has come back after treatment.

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I do not have any uncontrolled infections or heart problems.

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My leukemia is in its first chronic phase.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of Moderate and Severe Chronic GVHD at One Year Post Transplant

Secondary study objectives

GVHD- and Relapse- Free Survival by One Year Post Transplant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cyclophosphamide and abataceptExperimental Treatment2 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 tacrolimusActive Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

abatacept

2006