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NCT00476190 · ClinicalTrials.gov registry record · Phase 2
ALL Adult Consortium Trial: Adult ALL Trial
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT00476190: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00476190 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00476190, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add drugs called PEG-asparaginase and E. coli asparaginase. PEG-asparaginase has been given as an injection in the past and has been used in treatment with both children and adults with ALL. Information from those other research studies suggests that intravenous PEG-asparaginase has been administered safely in both children and adults. We hope to gain more information about the participants disease and how it responds to standard chemotherapy drugs used to treat ALL\>
Primary Outcome
Feasibility based on the rate of asparaginase completed defined as the percentage of patients who, after having achieved a complete remission after induction therapy, complete \>25 weeks of IV PEG asparaginase as part of intensification therapy. Complete remission is defined as an interpretable bone marrow (a specimen with normal marrow elements present) with fewer than 5% lymphoblasts and peripheral blood without lymphoblasts, and an antigen presenting cell (APC) \> 1000/mm3 and platelets \> 10
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Vincristine
- DRUG Cytarabine
- DRUG Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2007-04 |
| Est. Completion | 2020-03 |
| Phase | Phase 2 |
What the finished NCT00476190 record still lists
NCT00476190 is an interventional study that assigns participants to a tested intervention. The registered 112 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 (16% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00476190 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00476190 about?
NCT00476190 is a clinical study titled "ALL Adult Consortium Trial: Adult ALL Trial". The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add drugs called PEG-asparaginase and E. coli asparaginase...
What is the current status of trial NCT00476190?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2007-04. Estimated completion is 2020-03.
What interventions are being tested in trial NCT00476190?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Vincristine (DRUG), Cytarabine (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT00476190?
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 NCT00476190's enrollment target sits among peer trials
112 631st of 2000 higher than 1,369 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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