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NCT01656031 · ClinicalTrials.gov registry record · Phase 2
A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia
A Phase 2 study of Leukemia, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT01656031: Completed Phase 2 study of Leukemia, sponsored by Wake Forest University Health Sciences.
NCT01656031 is a Phase 2 study of Leukemia that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 39 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01656031, a Phase 2 study of Leukemia, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.
Primary Outcome
Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (\>20% with maturation of all cell lines), \<5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.
Conditions Studied
Interventions
- DRUG clofarabine
- DRUG cytarabine
Study Locations (1)
North Carolina
- Wake Forest University Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2005-02 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
What the finished NCT01656031 record still lists
NCT01656031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which clofarabine is the first listed.
NCT01656031 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01656031 about?
NCT01656031 is a clinical study titled "A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia". RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I...
What is the current status of trial NCT01656031?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2005-02. Estimated completion is 2008-11.
What conditions does trial NCT01656031 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT01656031?
The interventions under investigation include: clofarabine (DRUG), cytarabine (DRUG).
Who is sponsoring clinical trial NCT01656031?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01656031 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01656031's enrollment target sits among peer trials
39 140th of 233 higher than 92 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia 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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