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Non-TBI Conditioning for HCT in Acute Lymphoblastic Leukemia

Q: How many test sites are there for this trial?

<p>Children's Healthcare of Atlanta in <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>, Riley Hospital for Children - <a href="https://www.withpower.com/clinical-trials/indiana">Indiana</a> University , and Floating Hospital for Children at Tufts Medical Center are some of the notable locations where this study is taking place. In total, there are 28 hospitals running this trial.</p>

Phase 2

Recruiting

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

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

Must have

T-ALL and MPAL patients undergoing first allogeneic HCT

Any patient with ALL who undergoes Myeloablative HCT meeting specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

Study Summary

This trial will test whether a non-TBI conditioning regimen is effective for B-ALL patients with low risk of relapse as defined by NGS-MRD.

Who is the study for?

This trial is for children, adolescents, and young adults aged 1-25 with B-ALL leukemia who are candidates for a stem cell transplant. They must have low relapse risk indicated by negative NGS-MRD (a type of genetic test) in their bone marrow before the transplant. Participants need to be in first or second remission and have good organ function. Those with certain conditions like CNS relapse history or HIV are not eligible.Check my eligibility

What is being tested?

The study tests if a non-TBI (no total body irradiation) conditioning regimen before hematopoietic cell transplantation can work for patients with B-ALL who show no minimal residual disease through next-generation sequencing. It compares this approach against standard treatments that include TBI.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally, myeloablative conditioning can cause fatigue, infections due to lowered immunity, nausea/vomiting, mouth sores, and may affect organ functions which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

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

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I am receiving my first bone marrow transplant for T-ALL or MPAL.

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I have ALL and am undergoing a specific bone marrow transplant.

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I had a specific treatment before my stem cell transplant and my cancer was not detectable by a sensitive test.

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I have had more than two complete remissions after blinatumomab treatment.

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My tests show no minimal residual disease before my third or later complete remission.

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My child is under 1 year old and has no detectable cancer before a transplant.

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I am MRD negative and will receive a stem cell transplant from a half-matched donor.

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I am in my third or later remission after CAR-T cell therapy.

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I am in my second complete remission and have no minimal residual disease before a stem cell transplant, but I've had a CNS relapse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Two Year Event-free Survival

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment2 Interventions

Patients enrolled to the observational arm that are NGS-MRD pre-HCT are considered for the Treatment Arm. Patients will receive a myeloablative non-TBI conditioning regimen prior to the transplant consisting on busulfan, fludarabine and thiotepa. Patients will be followed for outcome for up to 5 years.

Group II: Observational ArmExperimental Treatment1 Intervention

Patients are enrolled to the observational arm to proceed with NGS-MRD testing pre-HCT. If NGS-MRD negative, eligible patients may be considered for the Treatment Arm to receive a myeloablative non-TBI conditioning regimen prior to HCT. If NGS-MRD positive, patients may continue in the observational arm and receive HCT under the direction of their transplant physician and followed on the study for outcome.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,076,429 Total Patients Enrolled

Hisham Abdel-Azim, MDStudy Chair - Children's Hospital Los Angeles

Children's Hospital Los Angeles

University Of Cairo (Medical School)

Children'S Hosp Of L A (Residency)

1 Previous Clinical Trials

25 Total Patients Enrolled

Troy Quigg, DOStudy ChairMethodist Hospital - Texas Transplant Institute

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Myeloablative allogeneic HCT with a non-TBI conditioning regimen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03509961 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Observational Arm, Treatment Arm

Acute Lymphoblastic Leukemia Clinical Trial 2023: Myeloablative allogeneic HCT with a non-TBI conditioning regimen Highlights & Side Effects. Trial Name: NCT03509961 — Phase 2

Myeloablative allogeneic HCT with a non-TBI conditioning regimen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03509961 — Phase 2

Frequently Asked Questions

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

How can I sign up to participate in this research?

"Eligibility for this leukemia clinical trial requires that patients are between the ages of 1 Year and 25. The study is looking to recruit up to 95 participants."

Answered by AI

What is the FDA's official stance on this medication?

"The safety of this treatment was given a score of 2. This is because, although there are Phase 2 trials underway that support the safety of the medication, there is currently no data to suggest that it is an effective treatment."

Answered by AI

Does your research include elderly study participants?

"To be eligible for this particular clinical trial, patients must between the ages of 1 year and 25 years old. There are 478 other trials available for people who are younger than 18 and 1229 trials available for seniors."

Answered by AI

How many people total are researchers testing this on?

"In order for this clinical trial to move forward, 95 eligible patients must agree to participate. Treatment will be administered at different sites across America, such as Children's Healthcare of Atlanta in Atlanta, Georgia and Riley Hospital for Children - Indiana University in Indianapolis, Indiana."

Answered by AI

Are there any open slots for new patients in this research project?

"That is correct. The clinicaltrials.gov website says that the study is open and looking for 95 participants at 24 different hospitals or clinics."

Answered by AI

How many test sites are there for this trial?

"Children's Healthcare of Atlanta in Georgia, Riley Hospital for Children - Indiana University , and Floating Hospital for Children at Tufts Medical Center are some of the notable locations where this study is taking place. In total, there are 28 hospitals running this trial."

Answered by AI

Recent research and studies

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Successful Bone Marrow Transplantation with Intensive Post-transplant Intrathecal Chemotherapy for CNS Relapsed AML in 2 Infants

Andolina, Jeffrey R., Carol Fries, Renee Boulware, Alyssa Vargas, Ellen Fraint, Matthew Barth, Steven Ambrusko, Melanie Comito, and Philip Monteleone. 2021. “Successful Bone Marrow Transplantation with Intensive Post-transplant Intrathecal Chemotherapy for CNS Relapsed AML in 2 Infants”. Journal of Pediatric Hematology/oncology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mph.0000000000002151.

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The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL

Hisham Abdel-Azim 2018. "The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03509961.

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