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NCT01409161 · ClinicalTrials.gov registry record · Phase 2
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
A Phase 2 study of Acute Promyelocytic Leukemia With PML-RARA, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
- 5
- Study locations
NCT01409161 is a Phase 2 study of Acute Promyelocytic Leukemia With PML-RARA that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 151 participants, above the 111-participant average among 3 other Acute Promyelocytic Leukemia With PML-RARA trials with a reported enrollment target (36% higher). The trial reports 5 study locations across 1 state.
The verdict
NCT01409161, a Phase 2 study of Acute Promyelocytic Leukemia With PML-RARA, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotoxins, such as gemtuzumab ozogamicin, may find certain cancer cells and kill them without harming normal cells. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill more cancer cells.
Conditions Studied
Interventions
- DRUG Gemtuzumab Ozogamicin
- OTHER Laboratory Biomarker Analysis
- DRUG Arsenic Trioxide
- DRUG Tretinoin
Study Locations (5)
Texas
- M D Anderson Cancer Center - Houston
- MD Anderson Regional Care Center-Katy - Houston
- MD Anderson Regional Care Center-Bay Area - Nassau Bay
- MD Anderson Regional Care Center-Sugar Land - Sugar Land
- MD Anderson Regional Care Center-The Woodlands - The Woodlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2011-10-05 |
| Est. Completion | 2027-12-18 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01409161
The ClinicalTrials.gov registry entry for NCT01409161 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 111-participant average among 3 other Acute Promyelocytic Leukemia With PML-RARA trials with a reported enrollment target (36% higher). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Promyelocytic Leukemia With PML-RARA appearing as the primary indexed condition, and to 4 interventions - of which Gemtuzumab Ozogamicin is the first listed.
NCT01409161 reports 5 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01409161 about?
NCT01409161 is a clinical study titled "Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia". This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth o...
What is the current status of trial NCT01409161?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2011-10-05. Estimated completion is 2027-12-18.
What conditions does trial NCT01409161 study?
This clinical trial studies the following conditions: Acute Promyelocytic Leukemia With PML-RARA.
What interventions are being tested in trial NCT01409161?
The interventions under investigation include: Gemtuzumab Ozogamicin (DRUG), Laboratory Biomarker Analysis (OTHER), Arsenic Trioxide (DRUG), Tretinoin (DRUG).
Who is sponsoring clinical trial NCT01409161?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01409161 being conducted?
This trial has 5 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.