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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
ClinicalTrials.gov ID: NCT03509961
What this study is testing
What is Myeloablative allogeneic HCT with a non-TBI conditioning regimen?
Myeloablative allogeneic HCT with a non-TBI conditioning regimen is an investigational medicine, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- 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.
You likely can't join if
- 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...
- Patients who have received inotuzumab treatment prior to allogeneic HCT are NOT eligible for the study treatment arm. Inotuzumab treatment may...
- Patients receiving non-myeloablative conditioning are not allowed on the observational arm (reduced toxicity conditioning with Flu/Mel/Thio is...
- 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...
- Patients with active CNS leukemia or any other active site of extramedullary disease at the time of enrollment are not permitted.
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Oakland, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Wilmington, Delaware, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Kansas City, Missouri, United States
- Hackensack, New Jersey, United States
- Buffalo, New York, United States
- Charlotte, North Carolina, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Duarte, California, United States; Los Angeles, California, United States; Oakland, California, United States; San Francisco, California, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.