Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I (NCT02553460)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals: PRIMARY OBJECTIVE: * Determine the tolerability of incorporating bortezomib and vorinostat into an ALL chemotherapy backbone for newly diagnosed infants with ALL. SECONDARY OBJECTIVES: * Estimate the event-free survival and overall survival of infants with ALL who are treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone. * Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR. * Compare end of induction, end of consolidation, and end of reinduction MRD levels to Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant outcomes.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (5 items).
Location: Children's Hospital Los Angeles — Los Angeles, California
Age range: Not specified to 365 Days
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients with prior therapy, other than therapy specified in the Inclusion Criteria.
- Patients with mature B-cell ALL or acute myelogenous (AML).
- Patients with Down syndrome.
- Inability or unwillingness of legal guardian/representative to give written informed consent.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (15 Sites)
- Children's Hospital Los Angeles — Los Angeles, California
- Children's Hospital of Orange County — Orange, California
- Lucile Packard Children's Hospital Stanford University — Palo Alto, California
- Children's Hospital and Clinics of Minnesota — Minneapolis, Minnesota
- St. Jude Affiliate-Charlotte — Charlotte, North Carolina
- Cincinnati Children's Hospital — Cincinnati, Ohio
- Oregon Health and Science University — Portland, Oregon
- St. Jude Children's Research Hospital — Memphis, Tennessee
- Children's Hospital of the King's Daughters (CHKD) — Norfolk, Virginia
- Alberta Children's Hospital — Calgary, Alberta
- Stollery Children's Hospital — Edmonton, Alberta
- Children's & Women's Health Centre of British Columbia — Vancouver, British Columbia
- Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec
- The Montreal Children's Hospital (MUHC-McGill) — Montreal, Quebec
- Centre Hospitalier Universitaire de Quebec — Québec, Quebec
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: High risk patients will receive a reintensification phase prior to transplant in first remission.
More studies in Acute Lymphoblastic Leukemia
- Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia — Birmingham, Alabama
- Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia — Chicago, Illinois
- Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia — Birmingham, Alabama
- Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma — Charlotte, North Carolina
- European Prospective Investigation Into Childhood Cancer — New York, New York
- CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia — Bethesda, Maryland
Explore by condition: All Acute Lymphoblastic Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.