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Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
NCT02112916 · View on ClinicalTrials.gov ↗
Study Summary
This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cytarabine
- DRUG Daunorubicin
- DRUG Bortezomib
- DRUG Daunorubicin Hydrochloride
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center — Downey
- City of Hope Comprehensive Cancer Center — Duarte
- Loma Linda University Medical Center — Loma Linda
- Miller Children's and Women's Hospital Long Beach — Long Beach
- Children's Hospital Los Angeles — Los Angeles
- Cedars Sinai Medical Center — Los Angeles
- Valley Children's Hospital — Madera
- UCSF Benioff Children's Hospital Oakland — Oakland
- Kaiser Permanente-Oakland — Oakland
- Children's Hospital of Orange County — Orange
- Lucile Packard Children's Hospital Stanford University — Palo Alto
- Sutter Medical Center Sacramento — Sacramento
- University of California Davis Comprehensive Cancer Center — Sacramento
Arizona
- Banner Children's at Desert — Mesa
- Phoenix Childrens Hospital — Phoenix
- Banner University Medical Center - Tucson — Tucson
Alabama
- Children's Hospital of Alabama — Birmingham
- USA Health Strada Patient Care Center — Mobile
Alaska
- Providence Alaska Medical Center — Anchorage
Arkansas
- Arkansas Children's Hospital — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 847 participants |
| Start Date | 2014-10-04 |
| Est. Completion | 2026-09-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02112916
The ClinicalTrials.gov registry entry for NCT02112916 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 847 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Adult T Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02112916 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02112916 about?
NCT02112916 is a clinical study titled "Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma". This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymp...
What is the current status of trial NCT02112916?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 847 participants. The study started on 2014-10-04. Estimated completion is 2026-09-16.
What conditions does trial NCT02112916 study?
This clinical trial studies the following conditions: Adult T Acute Lymphoblastic Leukemia, Childhood T Acute Lymphoblastic Leukemia, Ann Arbor Stage II Adult Lymphoblastic Lymphoma, Ann Arbor Stage II Childhood Lymphoblastic Lymphoma, Ann Arbor Stage III Adult Lymphoblastic Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02112916?
The interventions under investigation include: Cyclophosphamide (DRUG), Cytarabine (DRUG), Daunorubicin (DRUG), Bortezomib (DRUG), Daunorubicin Hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02112916?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02112916 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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