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Abatacept for 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

Age between 18 and 65 years

KPS greater than or equal to 80

Must not have

Patients with inadequate organ function including specific criteria for creatinine clearance, bilirubin, AST, ALT, pulmonary function, and cardiac function

Prior autologous stem cell transplant within the preceding 12 months or prior allogeneic transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years post transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if adding abatacept to the usual medications given after a cord blood transplant can help prevent or reduce the risk of acute graft versus host disease in individuals with blood cancer. Participants

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

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I am between 18 and 65 years old.

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I can carry out normal activities with minimal symptoms.

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I have a specific type of blood cancer such as AML, ALL, or CML.

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I don't have a matching donor for a transplant.

Exclusion Criteria

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

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My kidney, liver, lungs, and heart are functioning well.

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I have had a stem cell transplant within the last year.

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

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Abatacept

2005

Completed Phase 4

~112250