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NCT00866749 · ClinicalTrials.gov registry record · Phase 2
Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT00866749: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00866749 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00866749, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
Objectives: A. Primary objective: 1 To assess the feasibility and the effectiveness of pediatric type therapy (augmented BFM) in patients age 12 through 40 with untreated precursor-B or T acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL). B. Secondary objective: 1. To evaluate the prognostic significance of minimal residual disease in bone marrow samples at the end of induction and at the end of consolidation in this group of patients. 2. To prospectively evaluate gene hypermethylation status in this group of patients. 3. To prospectively analyze asparaginase activity and anti-asparaginase antibody formation in this population of patients.
Primary Outcome
3-year EFS was calculated based on the participants with a complete response (CR). Study regimen considered successful if it exhibits a 3-year EFS rate greater than 60% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.
Interventions
- DRUG Cyclophosphamide
- DRUG Vincristine
- DRUG Daunorubicin
- DRUG PEG-asparaginase
- DRUG Intrathecal Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2006-09-12 |
| Est. Completion | 2018-07-26 |
| Phase | Phase 2 |
What the finished NCT00866749 record still lists
NCT00866749 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00866749 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00866749 about?
NCT00866749 is a clinical study titled "Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma". Objectives: A. Primary objective: 1 To assess the feasibility and the effectiveness of pediatric type therapy (augmented BFM) in patients age 12 through 40 with untreated precursor-B or T acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL). B. Secondary objective: 1. To evaluate th...
What is the current status of trial NCT00866749?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2006-09-12. Estimated completion is 2018-07-26.
What interventions are being tested in trial NCT00866749?
The interventions under investigation include: Cyclophosphamide (DRUG), Vincristine (DRUG), Daunorubicin (DRUG), PEG-asparaginase (DRUG), Intrathecal Methotrexate (DRUG).
Who is sponsoring clinical trial NCT00866749?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00866749's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 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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