RecruitingPhase 2

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

A Phase II Pilot Trial to Estimate Survival After a Non-total Body Irradiation (TBI) Based Conditioning Regimen in Patients Diagnosed With B-acute Lymphoblastic Leukemia (ALL) Who Are Pre-allogeneic Hematopoietic Cell Transplantation (HCT) Next-generation-sequence (NGS) Minimal Residual Disease (MRD) Negative

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year to 25 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "NGS-MRD peripheral blood sample only at 6 months and 9 months post-HCT; (Blast specimen at time of diagnosis or relapse is required for NGS-MRD testing)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether young people with B-ALL, a type of blood cancer, can prepare for a donor stem cell transplant without whole-body radiation. The treatment group is for ages 1–25 whose bone marrow test finds no tiny amounts of cancer before transplant. Other patients may join a group that receives usual care and is followed by the study.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Treatment group: Ages 1–25 with B-ALL in their first or second remission, meaning signs of cancer have gone away.
  • Treatment group: A sensitive bone marrow test called NGS-MRD must find no remaining cancer before transplant.
  • Treatment group: No past stem cell transplant from a donor.
  • Treatment group: Past blinatumomab or CAR-T cell treatment is allowed if you are in your first or second remission.
  • Treatment group: A score of at least 60% on a test of daily activity or play.
  • Treatment group: Lung, kidney, heart, and liver tests must meet study limits within 4 weeks before transplant preparation starts.
  • Treatment group: You or your legal guardian must be able to give consent.
  • Observation group: Patients with ALL getting a transplant after strong treatment to destroy bone marrow may qualify, including some who cannot or choose not to join the treatment group.

Who can't join

  • Treatment group only: Cancer that returned in the brain or spinal cord before your second remission.
  • Treatment group only: Past treatment with inotuzumab.
  • Treatment group only: T-ALL or mixed-phenotype acute leukemia (MPAL), other types of blood cancer. These patients may join the observation group.
  • Observation group: Lower-strength preparation called non-myeloablative conditioning is not allowed. The Flu/Mel/Thio preparation is allowed.
  • Pregnant or breastfeeding.
  • HIV or an uncontrolled fungal, bacterial, or viral infection. A past fungal infection may be allowed if treatment worked well and scans show little or no disease that is not worsening.
  • Active leukemia in the brain or spinal cord, or active cancer elsewhere outside the bone marrow.
  • Certain inherited disorders linked to a high risk of leukemia and poor treatment results, such as Fanconi anemia, Kostmann syndrome, or dyskeratosis congenita.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria for the Observational Arm: Any patient with ALL who undergoes Myeloablative HCT including any of the following: * Patients who are pre-HCT NGS-MRD positive. * Patients \<1 year old who are pre-HCT NGS-MRD negative. * Patients who are pre-HCT NGS-MRD negative (CR1/CR2) who received inotuzumab ozogamicin therapy before proceeding to HCT. * Patients who are pre-HCT NGS-MRD negative and will be receiving haploidentical HCT. * Patients who are pre-HCT NGS-MRD negative in CR2 with history of CNS relapse. * Patients who have received blinatumomab, but are \>CR2 prior to HCT. * Patients who have received CART-T cellular therapy, but are \>CR2 prior to HCT. * Patients with pre-HCT NGS-MRD negative in ≥ CR3. * Any T-ALL and MPAL patients undergoing first allogeneic HCT * Any patient who is pre-HCT NGS-MRD negative and eligible for participation in the treatment arm but family does not consent for treatment arm or treating physician believe it is in the patient best interest not to enroll on the treatment arm Inclusion Criteria for the Treatment Arm: * Pre-HCT NGS-MRD negative * Age ≥ 1 year and ≤ 25 years * Disease status: B-ALL in first (CR1) or second remission (CR2) * No prior allogeneic hematopoietic stem cell transplant. * Patients in CR1 or CR2 after blinatumomab treatment. * Patients in CR1 or CR2 after CAR-T cellular therapy. * Karnofsky Index or Lansky Play-Performance Scale ≥ 60 % on pre-transplant evaluation. Karnofsky scores must be used for patients \> 16 years of age and Lansky scores for patients \< 16 years of age. * Able to give informed consent if \> 18 years, or with a legal guardian capable of giving informed consent if \< 18 years. * Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as: * Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen. * Renal: Creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73 m2 or a serum creatinine based on age/gender. * Cardiac: Shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA), choice of test according to local standard of care. * Hepatic: SGOT (AST) or SGPT (ALT) \< 5 x upper limit of normal (ULN) for age. Conjugated bilirubin \< 2.5 mg/dL, unless attributable to Gilbert's Syndrome. Exclusion Criteria: * CR2: exclude patients with history of CNS relapse (i.e. in CR2 with history of CNS isolated or combined relapse; CNS 2 will also be considered as CNS 3 for this purpose) from the treatment arm of study (can be enrolled on the observational arm). * Patients who have received inotuzumab treatment prior to allogeneic HCT are NOT eligible for the study treatment arm. Inotuzumab treatment may increase the risk of VOD/SOS for any allogeneic HCT recipient, but could potentiate the risk for with busulfan-based myeloablation (study-directed non-TBI conditioning). All inotuzumab-treated patients are eligible for the observational arm (HCT center standard of care). * Patients receiving non-myeloablative conditioning are not allowed on the observational arm (reduced toxicity conditioning with Flu/Mel/Thio is allowed on the observational arm). * Pregnant or lactating females are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants. * Patients with HIV or uncontrolled fungal, bacterial or viral infections are excluded. Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no evidence or minimal evidence of non-progressive disease remaining by CT evaluation. * Patients with active CNS leukemia or any other active site of extramedullary disease at the time of enrollment are not permitted. * T-ALL and MPAL patients are only allowed on the observational arm. * Patients with genetic disorders (generally marrow failure syndromes) prone to secondary AML/ALL with known poor outcome are not eligible (Fanconi Anemia, Kostmann Syndrome, Dyskeratosis Congenita, etc).

Study sites (24)

AL

AZ

CA

CO

CT

DE

FL

GA

IN

MA

MI

MO

NC

NJ

NY

TX