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Alkylating agents
Cyclophosphamide + Abatacept + Tacrolimus for Graft-versus-Host Disease
Phase 2
Recruiting
Led By Jaime Suarez Londono
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 730
Awards & highlights
No Placebo-Only Group
Summary
This trial involves treating adults with blood cancers using less intense chemotherapy, followed by a stem cell transplant from a family member. Medications are given to prevent complications where the new cells might attack the patient's body.
Who is the study for?
Adults with blood cancers needing a stem cell transplant from a relative can join if they're over 18, infection-free, have good kidney/liver/heart function, and are generally fit (Karnofsky score ≥ 70%). Women must not be pregnant and agree to contraception. Men must also use contraception. No recent heart attacks or severe heart disease allowed.
What is being tested?
This phase II trial tests Cyclophosphamide, Abatacept, and Tacrolimus in preventing Graft-versus-Host Disease after stem cell transplants from half-matched donors. It's an open-label study where all participants receive the same drugs following their transplant.
What are the potential side effects?
Possible side effects include immune system suppression leading to increased infection risk, liver/kidney problems due to drug toxicity, potential for allergic reactions to medication components, and general discomfort like nausea or fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 730
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 730
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative Incidence of Grades II-IV Acute GvHD
Secondary study objectives
Cumulative Incidence of Chronic GvHD
GvHD and Relapse-Free Survival (GRFS) Rate
Number of Participants Presenting with Poor Graft Function
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration TacrolimusExperimental Treatment3 Interventions
Participants to receive:
* Cyclophosphamide 25 mg/kg IV over 1 hour on Day 3 and Day 4 following transplant
* Abatacept 10 mg/kg IV on Day 5, Day 14, Day 28, and Day 56 following transplant
* Tacrolimus 0.02 mg/kg IV by continuous infusion, starting on Day 5 following transplant. May switch to oral administration when tolerated, adjusted to maintain a drug level between 5-12ng/mL. Tacrolimus treatment is continued until Day 60 and then tapered over a period of 4 weeks in the absence of GvHD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Abatacept
2005
Completed Phase 4
~112250
Tacrolimus
2019
Completed Phase 4
~5510
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Graft-versus-Host Disease (GvHD) include Cyclophosphamide, Abatacept, and Tacrolimus. Cyclophosphamide eliminates alloreactive T cells that attack the host's tissues.
Abatacept inhibits T-cell activation by blocking necessary co-stimulatory signals. Tacrolimus suppresses T-cell activation and proliferation by inhibiting calcineurin, a protein essential for T-cell activation.
These treatments are vital for GvHD patients as they help prevent donor immune cells from attacking the recipient's body, thereby reducing the incidence and severity of GvHD.
Successful treatment with reduced-intensity stem cell transplantation in a case of relapsed refractory central nervous system lymphoma.Sustained molecular remission in a patient with CML in blastic crisis receiving dose-reduced hematopoietic stem-cell transplantation followed by early withdrawal of cyclosporine and prophylactic use of interferon-alpha.
Successful treatment with reduced-intensity stem cell transplantation in a case of relapsed refractory central nervous system lymphoma.Sustained molecular remission in a patient with CML in blastic crisis receiving dose-reduced hematopoietic stem-cell transplantation followed by early withdrawal of cyclosporine and prophylactic use of interferon-alpha.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,400 Previous Clinical Trials
854,857 Total Patients Enrolled
Jaime Suarez LondonoPrincipal InvestigatorNYU Langone Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a male willing to use contraception or abstain from sex for the study duration and 90 days after.I have specific antibodies against the donor's tissue.I do not have any worsening infections.I am able to care for myself but may not be able to do active work.I am 18 years old or older.My liver function tests are within normal limits, except I may have Gilbert's syndrome.I am not pregnant or nursing and will use birth control if of childbearing age.I haven't had a heart attack or severe heart issues in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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