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NCT01403415 · ClinicalTrials.gov registry record · Phase 1
Temsirolimus, Dexamethasone, Mitoxantrone Hydrochloride, Vincristine Sulfate, and Pegaspargase in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
A Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia and Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 20
- Study locations
NCT01403415 is a Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia and Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants, below the 126-participant average among 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT01403415, a Phase 1 study of Recurrent Childhood Acute Lymphoblastic Leukemia and Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I trial studies the side effects and the best dose of temsirolimus when given together with dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase in treating young patients with relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus with combination chemotherapy may be and effective treatment for acute lymphoblastic leukemia or non-Hodgkin lymphoma.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Dexamethasone
- DRUG Methotrexate
- DRUG Pegaspargase
- DRUG Mitoxantrone Hydrochloride
Study Locations (20)
California
- Childrens Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Parnassus - San Francisco
Minnesota
- Children's Hospitals and Clinics of Minnesota - Minneapolis - Minneapolis
- University of Minnesota Medical Center-Fairview - Minneapolis
Missouri
- The Childrens Mercy Hospital - Kansas City
- Washington University School of Medicine - St Louis
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Rainbow Babies and Childrens Hospital - Cleveland
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Egleston - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01403415
The ClinicalTrials.gov registry entry for NCT01403415 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 126-participant average among 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials with a reported enrollment target (90% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Recurrent Childhood Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01403415 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Minnesota, Missouri.
Frequently Asked Questions
What is clinical trial NCT01403415 about?
NCT01403415 is a clinical study titled "Temsirolimus, Dexamethasone, Mitoxantrone Hydrochloride, Vincristine Sulfate, and Pegaspargase in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma". This phase I trial studies the side effects and the best dose of temsirolimus when given together with dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase in treating young patients with relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Temsirolimus may stop...
What is the current status of trial NCT01403415?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-09.
What conditions does trial NCT01403415 study?
This clinical trial studies the following conditions: Recurrent Childhood Acute Lymphoblastic Leukemia, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Childhood B Acute Lymphoblastic Leukemia, Childhood T Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT01403415?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Dexamethasone (DRUG), Methotrexate (DRUG), Pegaspargase (DRUG), Mitoxantrone Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01403415?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01403415 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.