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Cy/Flu/Thio/TBI + dCBT + Tac/MMF + Abatacept for Chronic Myelomonocytic Leukemia

Phase 2

Waitlist Available

Led By Leland Metheny, MD

Research Sponsored by Leland Metheny

Eligibility Criteria Checklist

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

Must have

* Antecedent hematological disease (e.g., myelodysplasia (MDS))

* Treatment-related leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years post transplant

Awards & highlights

No Placebo-Only Group

Summary

The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT. Participants will: * Partake in exams, tests, and procedures as part of usual cancer care. * Partake in conditioning, which is the treatment that is given before a transplant. * Have a cord blood transplant. * Partake in radiation following the transplant.

Who is the study for?

This trial is for individuals with certain blood cancers like leukemia, lymphoma, and myelodysplastic syndrome. It's also open to those with specific genetic conditions such as Klinefelter or Triple X Syndrome. Participants must be suitable for a cord blood transplant and able to undergo pre-transplant conditioning treatments including radiation.

What is being tested?

The study tests if adding abatacept to the standard graft versus host disease prevention (which includes tacrolimus and MMF) can reduce complications after a double umbilical cord transplant in blood cancer patients. The safety and effectiveness of abatacept in this context are being evaluated.

What are the potential side effects?

Potential side effects may include immune system suppression leading to increased infection risk, reactions at infusion sites, liver function changes, gastrointestinal issues from medication like MMF or Tacrolimus, and general discomfort from total body irradiation.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years post transplant for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Severe aGVDH free survival

Secondary study objectives

Assessment of aGVDH biomarker REG3α

Assessment of aGVDH biomarker ST2

CMV reactivation rate

+13 more

Awards & 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: Cy/Flu/Thio/TBI + dCBT + Tac/MMF + AbataceptExperimental Treatment8 Interventions

Cyclophosphamide (Cy), fludarabine (Flu), thiotepa (Thio), and total body irradiation (TBI) is the preparative regimen for Double Umbilical Cord Transplant (dCBT). Graft-versus-host disease prophylaxis will consist of tacrolimus (Tac) and mycophenolate mofetil (MMF). Abatacept will be administered.

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