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: Review the eligibility criteria below.
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 ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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.
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
- Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia — Birmingham, Alabama
- Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia — Duarte, California
- Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL) — Memphis, Tennessee
- Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy — Duarte, California
- Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease — Houston, Texas
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.