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Monoclonal Antibodies

ATG Dosing for Blood Cancer

Phase 2

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Pulmonary function: DLCO ≥50% and FEV1≥50%

Liver function: total bilirubin < 1.5x the upper limit of normal and ALT/AST < 2.5x the upper normal limit

Must not have

Autologous hematopoietic stem cell transplant < 3 months prior to enrollment

Previous allogeneic stem cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve outcomes after stem cell transplants by changing the timing and dosage of a medication called anti-thymocyte globulin (ATG). By giving most of the ATG dose before

Who is the study for?

This trial is for individuals with acute leukemia, myeloproliferative disorders, preleukemia, or myelodysplastic syndromes who are undergoing allogeneic stem cell transplant. The study aims to prevent severe graft versus host disease (GVHD). Specific eligibility criteria details were not provided.

What is being tested?

The trial tests a new way of giving anti-thymocyte globulin (ATG) in two steps before the transplant to reduce GVHD while improving immune response and survival without relapse or GVHD at one year post-transplant. It's combined with standard tacrolimus and mini methotrexate.

What are the potential side effects?

Potential side effects may include reactions related to ATG such as fever, chills, rash; effects from tacrolimus like high blood pressure, kidney problems; and issues from methotrexate including mouth sores and low blood counts.

Eligibility Criteria

Inclusion Criteria

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

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My lung function tests show at least half the normal capacity.

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My liver tests are within the required range.

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I agree to use birth control or abstain from sex.

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I am between 18 and 75 years old.

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I am able to care for myself but may not be able to do active work.

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I have been diagnosed with AML, MDS, or Myelofibrosis.

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I have a stem cell donor who matches the required HLA criteria.

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My heart pumps well, with an ejection fraction over 40%.

Exclusion Criteria

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

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I had a stem cell transplant using my own cells less than 3 months ago.

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I have had a stem cell transplant from a donor.

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I do not have uncontrolled heart problems or abnormal heart rhythms.

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I have an infection that is not under control.

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I have been diagnosed with cirrhosis.

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My leukemia is active with more than 5% of immature blood cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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

Rate of GRFS (graft versus host disease GVHD, relapse free survival) at 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

1Treatment groups

Experimental Treatment

Group I: phase II single arm study of 2 step ATG dosing in prevention of aGVHDExperimental Treatment1 Intervention

The primary outcome for the study is GRFS rate at one-year post transplant. GRFS will be estimated using Kaplan Meier method The reported GRFS with recent phase III trial of PTCY/tac/MMF in transplant from matched related and unrelated donors at 1 year follow up was 52%. We hypothesize that with 2 step ATG/Tac/Mini MTX regimen, we can achieve a one year GRFS of 69%.

0 / 14Eligibility criteria met