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Immunosuppressant

GVHD Prophylaxis After Bone Marrow Transplant for Blood Cancers

Phase 2
Recruiting
Led By Ashok Srinivasan, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patients of childbearing age must have a negative pregnancy test
Patients with secondary acute myeloid leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post-transplantation
Awards & highlights

Study Summary

This trial is asking people with blood cancer who need a bone marrow transplant to join, to find new ways of preventing severe side effects.

Who is the study for?
This trial is for children and young adults (12 years or older) with various types of blood cancers, including leukemia and lymphoma, who need a bone marrow transplant. They must have a matched donor, be in good physical condition with proper organ function, and not have had previous transplants. Those with HIV, Hepatitis B/C or latent tuberculosis are excluded.Check my eligibility
What is being tested?
The study tests a new way to prevent graft-versus-host disease after bone marrow transplant by avoiding certain immune-suppressing drugs after day +60. It includes medications like Ruxolitinib and Cyclophosphamide along with radiation therapy to see if this reduces severe acute GVHD without affecting the transplant's success.See study design
What are the potential side effects?
Possible side effects include reactions to medication infusions, increased risk of infections due to suppressed immunity from treatments like ATG and chemotherapy agents that can cause nausea, vomiting, hair loss, mouth sores or liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am of childbearing age and have a negative pregnancy test.
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I have been diagnosed with secondary acute myeloid leukemia.
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I have been diagnosed with myelodysplastic syndrome.
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I am 12 years old or older.
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My Hodgkin's disease is not in its first remission or is not responding to treatment.
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My leukemia is in its first remission and considered high risk.
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I have a donor who is a perfect match for me.
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My Non-Hodgkin's lymphoma is not in its first remission or is resistant to treatment.
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My leukemia is of a mixed or unclear type.
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My condition is either newly diagnosed AML, AML in or beyond first remission, relapsed, refractory, or I have myeloid sarcoma.
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My brain leukemia was treated and is now in complete remission.
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My condition is NK cell leukemia and I am in remission.
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I have been diagnosed with Juvenile Myelomonocytic Leukemia.
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I have chronic myelogenous leukemia.
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My kidney function, measured by creatinine clearance or GFR, is good.
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My leukemia has returned after the first treatment.
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I am mostly able to care for myself and carry out normal activities.

Timeline

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
Graft-vs-Host Disease
Secondary outcome measures
Incidence of Chronic Graft Versus Host Disease (cGVHD)
Incidence of Leukemic Relapse
Perinatal death
+1 more

Trial Design

2Treatment groups
Active Control
Group I: ArmA- LymphoidActive Control8 Interventions
Total Body Irradiation and cyclophosphamide (TBI/Cy)
Group II: ArmB-MyeloidActive Control8 Interventions
TBF with comparable NRM in comparison to busulfan and cyclophosphamide (BuCy)

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
427 Previous Clinical Trials
5,306,545 Total Patients Enrolled
Ashok Srinivasan, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
5 Previous Clinical Trials
496 Total Patients Enrolled

Media Library

Anti-thymocyte globulin (ATG) (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05579769 — Phase 2
Myeloid Leukemia Research Study Groups: ArmA- Lymphoid, ArmB-Myeloid
Myeloid Leukemia Clinical Trial 2023: Anti-thymocyte globulin (ATG) Highlights & Side Effects. Trial Name: NCT05579769 — Phase 2
Anti-thymocyte globulin (ATG) (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05579769 — Phase 2

Frequently Asked Questions

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

Has ArmA-Lymphoid received regulatory authorization from the FDA?

"Given that ArmA-Lymphoid is a Phase 2 trial, and thus lacks evidence of efficacy but does have some data indicating safety, our team at Power has assigned it a score of two."

Answered by AI

How many participants are actively engaged in this clinical experiment?

"Affirmative. Clinicaltrials.gov reflects that this clinical trial is currently enrolling patients, starting from the 4th of November 2022 and updated as recently as the 7th of November 2022. There are 32 positions available at a single medical facility."

Answered by AI

Are there any vacancies left to join this clinical experiment?

"Affirmative. Details available on clinicaltrials.gov demonstrate that the trial, which was published on November 4th 2022 is actively enrolling individuals. Specifically, 1 research site requires 32 volunteers to participate in this project."

Answered by AI
~19 spots leftby Apr 2026