Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00866307 · ClinicalTrials.gov registry record · Phase 1

Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

A Phase 1 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 1
Development phase
104
Enrollment target

NCT00866307: Completed Phase 1 study, sponsored by Children's Oncology Group.

NCT00866307 is a Phase 1 study that has completed, run by Children's Oncology Group. The registered enrollment target is 104 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00866307, a Phase 1 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 1
Development phase
104 participants
Enrollment target

Study Summary

This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) together with pegaspargase may kill more cancer cells.

Primary Outcome

Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Doxorubicin Hydrochloride
  • DRUG Dexamethasone
  • DRUG Cytarabine
  • DRUG Daunorubicin Hydrochloride

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2009-02-23
Est. Completion 2021-03-31
Phase Phase 1
Children's Oncology Group

342 total trials

What the finished NCT00866307 record still lists

NCT00866307 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00866307 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00866307 about?

NCT00866307 is a clinical study titled "Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)". This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell grow...

What is the current status of trial NCT00866307?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2009-02-23. Estimated completion is 2021-03-31.

What interventions are being tested in trial NCT00866307?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00866307?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00866307's enrollment target sits among peer trials

104 536th of 2000 higher than 1,460 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03403686 · 104 participants

    Liver X Receptor (LXR) as a Novel Therapeutic Target in Diabetic Retinopathy (DR)

  • NCT04228367 · 104 participants · NA

    JuggerStitch Post Market Clinical Follow-up Study

  • NCT04268849 · 104 participants · Phase 3

    Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient

  • NCT04390724 · 104 participants

    Optimizing Y90 Therapy for Radiation Lobectomy

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT00866307, the US trial registry maintained by the National Library of Medicine. NCT00866307 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.