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Monoclonal Antibodies

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

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post transplant

Awards & highlights

Study Summary

This trial aims to see if combining three drugs, tacrolimus, methotrexate, and rabbit Anti-thymocyte Globulin (ATG), with a new dosing strategy, can help

Who is the study for?

This trial is for individuals with conditions like Myelodysplastic Syndrome, Preleukemia, or Acute Leukemia who are undergoing a myeloablative allogeneic stem cell transplant. The goal is to prevent acute Graft-versus-Host Disease (GVHD). Specific eligibility criteria details were not provided.Check my eligibility

What is being tested?

The study tests if using Anti-thymocyte Globulin (ATG) in a new dosing strategy along with Tacrolimus and Mini Methotrexate can prevent or lessen the severity of acute and/or chronic GVHD after stem cell transplant.See study design

What are the potential side effects?

Potential side effects may include immune system suppression leading to increased infection risk, reactions related to infusion of ATG, liver function changes due to Tacrolimus, and mouth sores or low blood counts from Methotrexate.

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

To estimate the therapeutic success of 2-step ATG dosing platform in patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances

Trial Design

1Treatment groups

Experimental Treatment

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

The primary outcome for the study is rate of GRFS at one-year post transplant. When accounting for competing risks, any death, relapse, Grade III-IV acute GVHD and cGVHD requiring systemic therapy are competing risks. The reported one year GRFS with the use of standard of care GVHD prevention regimen in MA HSCT (Tac/MTX) was 35%. (El-Jurdi 2023) We hypothesize that with 2 step ATG/Tac/Mini MTX regimen, we can achieve a one year GRFS of 60%.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,583 Previous Clinical Trials

2,280,015 Total Patients Enrolled

Frequently Asked Questions

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

Do individuals younger than 40 meet the criteria for participating in this medical study?

"Eligible participants must be above 18 years of age but below 60 to enroll in this clinical study."

Answered by AI

Is the enrollment process currently open for this clinical trial?

"The data on clinicaltrials.gov shows that this particular medical trial is not currently seeking participants. Initially posted on 4/29/2024 and most recently revised on 3/11/2024, it is inactive in terms of patient recruitment. Nonetheless, amidst the plethora of ongoing trials, there are approximately 500 others actively enrolling patients at present."

Answered by AI

What are the safety considerations for individuals participating in a phase II single arm trial involving 2-step ATG dosing to prevent acute graft-versus-host disease?

"Given that this trial is categorized as a Phase 2 study, our evaluation rates the safety of the phase II single arm research involving two-step ATG dosing for acute graft-versus-host disease prevention at level 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Zaid Al-Kadhimi 2024. "Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06315309.

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