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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: Completed 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).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

A descriptive summary of all toxicities will be reported.

Conditions Studied

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

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

FieldValue
Enrollment Target 13 participants
Start Date 2011-09
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01403415 record still lists

NCT01403415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 126-participant average among 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials with a reported enrollment target (90% lower).

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 names 20 study sites across 14 states, led by 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.

Learn More About Clinical Trials

Similar trials for Recurrent Childhood Acute Lymphoblastic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01403415's enrollment target sits among peer trials

13 12th of 11 the lowest of 11 other Recurrent Childhood Acute Lymphoblastic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Childhood Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01403415, the US trial registry maintained by the National Library of Medicine. NCT01403415 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.