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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%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

occurrence of moderate and severe chronic GVHD at one year post transplant

Secondary outcome measures

GVHD- and relapse- free survival by one year post transplant

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

1995

Completed Phase 3

~3770

abatacept

2006

Completed Phase 4

~1180

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dimitrios Tzachanis, MD PhDLead Sponsor

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,471 Total Patients Enrolled

Divya Koura, MDPrincipal InvestigatorUniversity of California, San Diego

Media Library

Abatacept (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT03680092 — Phase 2

Blood Cancers Research Study Groups: Cyclophosphamide and abatacept, methotrexate and tacrolimus

Blood Cancers Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT03680092 — Phase 2

Abatacept (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03680092 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being observed in this clinical research?

"This particular trial has concluded its search for participants, having been posted on November 26th 2019 and last edited September 19th 2022. However, 274 studies of hematologic neoplasms are still actively recruiting patients as well 1066 trials utilizing Cyclophosphamide."

Answered by AI

Can you provide details of the research conducted with Cyclophosphamide?

"At the moment, 1066 trials involving Cyclophosphamide are operationally active. 209 of these clinical experiments have progressed to Phase 3. With the majority of studies situated in Philadelphia, Pennsylvania, a total of 30971 medical centres worldwide are running research with this drug."

Answered by AI

Are there any available openings in this clinical trial for participants?

"The clinical trial website states that this particular research project is no longer enrolling candidates. Initially posted on November 26th 2019, it has not been updated since September 19th 2022. Nevertheless, there are 1,340 other trials actively recruiting participants at the moment."

Answered by AI

What are the typical indications for Cyclophosphamide?

"Cyclophosphamide is a widely used medication for small cell lung cancer treatment. It can also be an effective remedy to address various medical issues such as dermatitis, atopic conditions, multiple sclerosis, leukemia and acute myelocytic sicknesses."

Answered by AI

Has Cyclophosphamide been approved by the United States Food and Drug Administration?

"The safety of cyclophosphamide has been estimated to rate 2 on a scale of 1-3, as this is classified as Phase 2. This indicates that there is some data present in support of its safety but none for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation

Dimitrios Tzachanis, MD PhD 2019. "Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03680092.

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