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Monoclonal Antibodies

phase II single arm study of 2 step ATG dosing in prevention of aGVHD for Acute Leukemia

Q: Are individuals aged 55 and above eligible to participate in this study?

Individuals older than 18 years and younger than 75 years are eligible for enrollment in this research.

Q: What are the eligibility criteria for individuals interested in participating in this research project?

Patients aged between 18 and 75 with a diagnosis of acute <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> are eligible for participation in this study, which aims to recruit approximately 56 individuals.

Q: What is the level of safety observed in a Phase II single-arm trial using dual-step ATG dosing to prevent acute graft-versus-host disease in individuals?

The safety evaluation for the phase II single arm study assessing two-step ATG dosing to prevent aGVHD is rated at 2 by our team. This rating reflects some existing safety data without corresponding efficacy evidence, typical of Phase 2 trials.

Q: Are there any available openings for patients to participate in this medical study?

According to information on clinicaltrials.gov, recruitment for this study is currently closed. The trial was first listed on March 29th, 2024 and had its latest update on February 16th of the same year. While this specific trial is not seeking new participants, there are a substantial number of 484 other ongoing studies actively recruiting individuals.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post transplant

Awards & highlights

Study 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.Check my eligibility

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.See study design

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%.

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

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

Primary outcome measures

Rate of GRFS (graft versus host disease GVHD, relapse free survival) at one year post transplant.

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,277,973 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals aged 55 and above eligible to participate in this study?

"Individuals older than 18 years and younger than 75 years are eligible for enrollment in this research."

Answered by AI

What are the eligibility criteria for individuals interested in participating in this research project?

"Patients aged between 18 and 75 with a diagnosis of acute leukemia are eligible for participation in this study, which aims to recruit approximately 56 individuals."

Answered by AI

What is the level of safety observed in a Phase II single-arm trial using dual-step ATG dosing to prevent acute graft-versus-host disease in individuals?

"The safety evaluation for the phase II single arm study assessing two-step ATG dosing to prevent aGVHD is rated at 2 by our team. This rating reflects some existing safety data without corresponding efficacy evidence, typical of Phase 2 trials."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"According to information on clinicaltrials.gov, recruitment for this study is currently closed. The trial was first listed on March 29th, 2024 and had its latest update on February 16th of the same year. While this specific trial is not seeking new participants, there are a substantial number of 484 other ongoing studies actively recruiting individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant

Zaid Al-Kadhimi 2024. "Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06265584.

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