Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Acute Promyelocytic Leukemia With PML-RARA, sponsored by M.D. Anderson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Monitored using a Bayesian time-to-event model.
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 |
What NCT01409161 shows while recruiting
NCT01409161 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 111-participant average among 3 other Acute Promyelocytic Leukemia With PML-RARA trials with a reported enrollment target (36% higher).
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 lists 5 locations in 1 state (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.
Learn More About Clinical Trials
Similar trials for Acute Promyelocytic Leukemia With PML-RARA
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.
-
Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
COMPLETED · Phase 2
-
PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia
ACTIVE NOT RECRUITING · Phase 1
-
Simplified Patient Care Strategy in Decreasing Early Death in Patients With Acute Promyelocytic Leukemia
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04245397 · 151 participants · Phase 1
Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
- NCT05761223 · 151 participants · Phase 1
A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
- NCT07195656 · 151 participants · NA
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
- NCT03328078 · 152 participants · Phase 1
CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI