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NCT00136435 · ClinicalTrials.gov registry record · Phase 2
A Study in Adults With Untreated Acute Lymphoblastic Leukemia
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00136435: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00136435 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00136435, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.
Primary Outcome
Feasibility based on the rate of asparaginase completion defined as the percentage of patients who, after having achieved a complete remission after induction therapy, complete all 30 doses of asparaginase as part of intensification therapy. Complete remission is defined as peripheral blood without lymphoblasts, a bone marrow with \<5% lymphoblasts, an antigen-presenting cell (APC) \> 1000/mm3, platelets \> 100,000/mm3, and no evidence of extramedullary leukemia.
Interventions
- DRUG prednisone
- DRUG doxorubicin
- DRUG vincristine
- DRUG methotrexate
- DRUG asparaginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2002-06 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT00136435 record still lists
NCT00136435 is an interventional study that assigns participants to a tested intervention. The registered 100 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 (25% lower).
The record links to 0 conditions, and to 5 interventions - of which prednisone is the first listed.
NCT00136435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00136435 about?
NCT00136435 is a clinical study titled "A Study in Adults With Untreated Acute Lymphoblastic Leukemia". The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.
What is the current status of trial NCT00136435?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2002-06. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00136435?
The interventions under investigation include: prednisone (DRUG), doxorubicin (DRUG), vincristine (DRUG), methotrexate (DRUG), asparaginase (DRUG).
Who is sponsoring clinical trial NCT00136435?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00136435's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 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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