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NCT00186875 · ClinicalTrials.gov registry record · Phase 2

Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia

A Phase 2 study, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
Phase 2
Development phase
47
Enrollment target

NCT00186875: Completed Phase 2 study, sponsored by St. Jude Children's Research Hospital.

NCT00186875 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00186875, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
Phase 2
Development phase
47 participants
Enrollment target

Study Summary

The main purpose of this study is to find out how well participants with relapsed or refractory ALL respond to treatment with an etoposide- and teniposide-based induction chemotherapy regimen and what the side effects are. Primary Objectives: * To estimate the response rate for patients with refractory or relapsed ALL. * To estimate the survival rate of patients with refractory or relapsed ALL treated with risk-directed therapy.

Primary Outcome

The "response rate" is defined as the proportion of participants who attain morphological complete remission after the re-induction Block C, inclusive of all patients who begin re-induction. Morphological complete remission was defined as \<5% blasts in bone marrow by morphology.

Interventions

  • DRUG Etoposide, cytarabine, vincristine, dexamethasone
  • DRUG methotrexate, teniposide, PEG-asparaginase
  • DRUG mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine
  • DRUG L-asparaginase, erwinia asparaginase
  • PROCEDURE chemotherapy, intrathecal chemotherapy, steroid therapy

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2003-11
Est. Completion 2016-08
Phase Phase 2

What the finished NCT00186875 record still lists

NCT00186875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 5 interventions - of which Etoposide, cytarabine, vincristine, dexamethasone is the first listed.

NCT00186875 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00186875 about?

NCT00186875 is a clinical study titled "Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia". The main purpose of this study is to find out how well participants with relapsed or refractory ALL respond to treatment with an etoposide- and teniposide-based induction chemotherapy regimen and what the side effects are. Primary Objectives: * To estimate the response rate for patients with refra...

What is the current status of trial NCT00186875?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2003-11. Estimated completion is 2016-08.

What interventions are being tested in trial NCT00186875?

The interventions under investigation include: Etoposide, cytarabine, vincristine, dexamethasone (DRUG), methotrexate, teniposide, PEG-asparaginase (DRUG), mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine (DRUG), L-asparaginase, erwinia asparaginase (DRUG), chemotherapy, intrathecal chemotherapy, steroid therapy (PROCEDURE).

Who is sponsoring clinical trial NCT00186875?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00186875's enrollment target sits among peer trials

47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00186875, the US trial registry maintained by the National Library of Medicine. NCT00186875 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.