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NCT01746836 · ClinicalTrials.gov registry record · Phase 2
Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib
A Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01746836: Recruiting Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, sponsored by M.D. Anderson Cancer Center.
NCT01746836 is a Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants, below the 72-participant average among 7 other Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01746836, a Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well ponatinib hydrochloride works as second line therapy in treating patients with chronic myeloid leukemia in chronic phase that has not responded to initial treatment (first line) with imatinib mesylate, dasatinib, or nilotinib or cannot tolerate imatinib mesylate, dasatinib, or nilotinib. Ponatinib hydrochloride may stop or control the growth of cancer cells by blocking a protein needed for cell growth.
Primary Outcome
The method of Kaplan and Meier will be used to estimate the unadjusted distribution of duration of MCyR. An appropriate time-to-event regression model will be fit to the event time data to assess the effects of patient covariates on the event time variable, with the particular model determined by preliminary goodness-of-fit analyses. The distribution of MCyR6 will be tabulated and effects of baseline patient covariates on this variable will be assessed by logistic regression.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DRUG Ponatinib Hydrochloride
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-01-17 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 2 |
What NCT01746836 shows while recruiting
NCT01746836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 72-participant average among 7 other Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive trials with a reported enrollment target (31% lower).
The record links to 3 conditions, with Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01746836 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01746836 about?
NCT01746836 is a clinical study titled "Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib". This phase II trial studies how well ponatinib hydrochloride works as second line therapy in treating patients with chronic myeloid leukemia in chronic phase that has not responded to initial treatment (first line) with imatinib mesylate, dasatinib, or nilotinib or cannot tolerate imatinib mesylate,...
What is the current status of trial NCT01746836?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2013-01-17. Estimated completion is 2030-12-31.
What conditions does trial NCT01746836 study?
This clinical trial studies the following conditions: Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia.
What interventions are being tested in trial NCT01746836?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Ponatinib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01746836?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01746836 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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