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RECRUITING Phase 2

Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

NCT01409161 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 151 participants
Start Date 2011-10-05
Est. Completion 2027-12-18
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,992 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,992 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01409161 reports 5 study locations spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01409161?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,992 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial