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NCT01094860 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies
A Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT01094860: Completed Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT01094860 is a Phase 1 study of Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 29 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01094860, a Phase 1 study of Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of the clinical research study is to find the highest tolerable dose of nelarabine when given as a continuous infusion to patients with a lymphoid malignancy that has not responded to, or has come back after treatment with chemotherapy. The safety of this drug will also be studied.
Primary Outcome
MTD defined as the highest dose that no more than 1 dose limiting toxicity (DLT) occurs among 6 patients. Dose-limiting toxicity (DLT) defined based on drug related events only. DLT in the first treatment cycle used for the dose escalation.
Conditions Studied
Interventions
- DRUG Nelarabine
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2010-06-08 |
| Est. Completion | 2018-08-09 |
| Phase | Phase 1 |
What the finished NCT01094860 record still lists
NCT01094860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Nelarabine is the first listed.
NCT01094860 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01094860 about?
NCT01094860 is a clinical study titled "Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies". The goal of the clinical research study is to find the highest tolerable dose of nelarabine when given as a continuous infusion to patients with a lymphoid malignancy that has not responded to, or has come back after treatment with chemotherapy. The safety of this drug will also be studied.
What is the current status of trial NCT01094860?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2010-06-08. Estimated completion is 2018-08-09.
What conditions does trial NCT01094860 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT01094860?
The interventions under investigation include: Nelarabine (DRUG).
Who is sponsoring clinical trial NCT01094860?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01094860 being conducted?
This trial has 1 study location across Texas. 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 NCT01094860's enrollment target sits among peer trials
29 166th of 233 higher than 65 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.
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