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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL
ClinicalTrials.gov ID: NCT05082519
What this study is testing
- What it's testing
- This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 25
You may be able to join if
- Patients must be ≥ 10.0 and \<26.0 years of age.
- Patients must have a diagnosis of de novo B-ALL
- Patients must have a M3 marrow (\>25% blasts by morphology) or at least 1,000/µL circulating leukemia cells in PB confirmed by Flow Cytometry (or...
- The treatment regimen must be the first treatment attempt for B-ALL-
- Must be a multi-agent induction regimen inclusive of vincristine, glucocorticoid, pegaspargase/calaspargase, and daunorubicin or doxorubicin and with...
You likely can't join if
- Patient will be excluded if they are underweight at time of enrollment (BMI% \<5th percentile for age for patients age 10-19 years, BMI \<18.5 in...
- Patients with Down syndrome or a DNA fragility syndrome (such as Fanconi anemia, Bloom syndrome) will be excluded.
- Patient receiving a SJCRH-style "Total Therapy" regimen will be excluded.
- Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy.
- Patients will be excluded if they received treatment for a previous malignancy.
- Patient will be excluded if they are pregnant.
See the full eligibility criteria
- Patients must be ≥ 10.0 and \<26.0 years of age.
- Patients must have a diagnosis of de novo B-ALL
- Patients must have a M3 marrow (\>25% blasts by morphology) or at least 1,000/µL circulating leukemia cells in PB confirmed by Flow Cytometry (or other convincing evidence of a B-ALL diagnosis not meeting above criteria...
- The treatment regimen must be the first treatment attempt for B-ALL-
- Must be a multi-agent induction regimen inclusive of vincristine, glucocorticoid, pegaspargase/calaspargase, and daunorubicin or doxorubicin and with a planned duration \<35 days.
- Organ function must meet that required for initiation of chemotherapy
- Patients at diagnosis must meet Karnofsky \> 50% for patients \> 16 years of age and Lansky \> 50% for patients ≤ 16 years of age (or be expected to recover prior to Day 8) .
- If the patient is a female of childbearing potential, a negative urine or serum pregnancy test is required within two weeks prior to enrollment.
- Patient will be excluded if they are underweight at time of enrollment (BMI% \<5th percentile for age for patients age 10-19 years, BMI \<18.5 in patients 20-29 years).
- Patients with Down syndrome or a DNA fragility syndrome (such as Fanconi anemia, Bloom syndrome) will be excluded.
- Patient receiving a SJCRH-style "Total Therapy" regimen will be excluded.
- Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy.
- Patients will be excluded if they received treatment for a previous malignancy.
- Patient will be excluded if they are pregnant.
- Patient will be excluded if they have a pre-diagnosis requirement for enteral or parenteral supplementation .
- Patient will be excluded due to inability to perform the intervention (e.g., specific nutritional needs, severe developmental delay, paraplegia)
- Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Milwaukee, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 10 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 14 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.