Non-TBI Conditioning for HCT in Acute Lymphoblastic Leukemia
Trial Summary
What is the purpose of this trial?
This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients diagnosed with B-ALL who are candidates for HCT will be screened by NGS-MRD on a test of bone marrow done before the HCT. Subjects who are pre-HCT NGS-MRD negative will be eligible to receive a non-TBI conditioning regimen as part of the treatment cohort of the study. Subjects who are pre-HCT NGS-MRD positive will be treated as per treating center standard and will be followed in an observational cohort (HCT center standard of care).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.
What data supports the effectiveness of the treatment Myeloablative allogeneic HCT with a non-TBI conditioning regimen for Acute Lymphoblastic Leukemia?
The research does not provide direct evidence for the effectiveness of non-TBI conditioning regimens in Acute Lymphoblastic Leukemia, but it highlights that myeloablative conditioning, in general, is an effective therapy for hematologic malignancies, and nonmyeloablative regimens have been developed to reduce toxicity while relying on the immune system to fight cancer.12345
Is non-TBI conditioning for HCT generally safe in humans?
Non-TBI conditioning regimens for hematopoietic cell transplantation (HCT) have been shown to have lower severe toxicities and nonrelapse mortality compared to traditional myeloablative regimens, making them a safer option for patients, especially those who are older or have other health issues.23678
How is the non-TBI conditioning treatment for acute lymphoblastic leukemia different from other treatments?
The non-TBI conditioning treatment for acute lymphoblastic leukemia is unique because it avoids the use of total body irradiation (TBI), which is commonly used in other conditioning regimens. This approach may reduce some of the toxic side effects associated with TBI, making it a potentially safer option for patients, especially in settings where TBI facilities are not available.39101112
Research Team
Abdel-Azim Hisham, MD
Principal Investigator
Loma Linda University
Troy Quigg, DO, MS
Principal Investigator
Helen DeVos Children's Hospital
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a myeloablative non-TBI conditioning regimen with busulfan, fludarabine, and thiotepa prior to hematopoietic cell transplantation
Follow-up
Participants are monitored for safety and effectiveness after treatment, with NGS-MRD testing at specified intervals
Long-term follow-up
Participants are followed for outcome for up to 5 years to estimate event-free survival
Treatment Details
Interventions
- Myeloablative allogeneic HCT with a non-TBI conditioning regimen
- NGS-MRD
Myeloablative allogeneic HCT with a non-TBI conditioning regimen is already approved in United States, European Union for the following indications:
- B-cell acute lymphoblastic leukemia (B-ALL) in NGS-MRD negative patients
- B-cell acute lymphoblastic leukemia (B-ALL) in NGS-MRD negative patients
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pediatric Transplantation & Cellular Therapy Consortium
Lead Sponsor
Children's Hospital Los Angeles
Lead Sponsor