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NCT01019317 · ClinicalTrials.gov registry record · Phase 2
Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
NCT01019317: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01019317 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 151 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01019317, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this drug combination will also be studied.
Primary Outcome
Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.
Interventions
- DRUG Fludarabine
- DRUG Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT01019317 record still lists
NCT01019317 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 2 interventions - of which Fludarabine is the first listed.
NCT01019317 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01019317 about?
NCT01019317 is a clinical study titled "Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)". The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this drug combination will als...
What is the current status of trial NCT01019317?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2009-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01019317?
The interventions under investigation include: Fludarabine (DRUG), Cytarabine (DRUG).
Who is sponsoring clinical trial NCT01019317?
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 NCT01019317's enrollment target sits among peer trials
151 454th of 2000 higher than 1,546 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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