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Arsenic-containing Agent

Tretinoin + Arsenic Trioxide (+/- Gemtuzumab) for Leukemia

Phase 2

Recruiting

Led By Farhad Ravandi-Kashani

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All sexually active subjects (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the study

A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the time from the start of treatment to first documentation of disease relapse or death, assessed up to 2 years

Awards & highlights

Study Summary

This trial is studying giving tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin to patients with acute promyelocytic leukemia that has not been previously treated.

Who is the study for?

This trial is for patients with a new diagnosis of acute promyelocytic leukemia (APL) confirmed by specific genetic tests. Participants must understand the study and agree to sign consent forms. Those who have started emergency APL treatment can join, and women of childbearing age need negative pregnancy tests before and during the study. Contraception use is required for all sexually active participants.Check my eligibility

What is being tested?

The trial is testing how well tretinoin and arsenic trioxide work together, with or without an additional drug called gemtuzumab ozogamicin, in treating newly diagnosed APL patients. The goal is to see if adding gemtuzumab ozogamicin can kill more cancer cells without harming normal cells.See study design

What are the potential side effects?

Possible side effects include reactions related to chemotherapy such as fatigue, nausea, hair loss, increased risk of infection; heart rhythm problems; liver function changes; or kidney issues. Gemtuzumab may cause targeted cell death but also might affect non-cancerous cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use two effective birth control methods during the study.

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My APL is confirmed by a specific gene test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the time from the start of treatment to first documentation of disease relapse or death, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the time from the start of treatment to first documentation of disease relapse or death, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and the time from the start of treatment to first documentation of disease relapse or death, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event free survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (tretinoin, arsenic trioxide, gemtuzumab ozogamicin)Experimental Treatment4 Interventions

INDUCTION: Patients receive tretinoin PO BID, arsenic trioxide IV over 1-2 hours daily, and gemtuzumab ozogamicin IV over 2 hours once at weeks 1-4. CONSOLIDATION: Patients achieving CR receive arsenic trioxide IV 5 days per week during weeks 1-4, 9-12, 17-20, and 25-28 and tretinoin PO BID for 2 weeks on and 2 weeks off. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tretinoin

2013

Completed Phase 4

~2040

Gemtuzumab Ozogamicin

2006

Completed Phase 4

~440

Arsenic Trioxide

2011

Completed Phase 3

~240

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,977 Previous Clinical Trials

1,789,387 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,691 Previous Clinical Trials

40,930,405 Total Patients Enrolled

Farhad Ravandi-KashaniPrincipal InvestigatorM.D. Anderson Cancer Center

8 Previous Clinical Trials

555 Total Patients Enrolled

Media Library

Arsenic Trioxide (Arsenic-containing Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01409161 — Phase 2

Acute Promyelocytic Leukemia Research Study Groups: Treatment (tretinoin, arsenic trioxide, gemtuzumab ozogamicin)

Acute Promyelocytic Leukemia Clinical Trial 2023: Arsenic Trioxide Highlights & Side Effects. Trial Name: NCT01409161 — Phase 2

Arsenic Trioxide (Arsenic-containing Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01409161 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Tretinoin most often employed?

"Tretinoin is used to treat acute promyelocytic leukemia and a variety of other conditions like keratinization disorders of the feet, severe, recalcitrant cystic acne, dermatologic disorders."

Answered by AI

Could you provide the total headcount for this experiment?

"That is correct. The clinical trial, which began recruiting on October 5th, 2011, as indicated by information available on clinicaltrials.gov, is still looking for participants. There are a total of 151 patients that need to be recruited from 5 different sites."

Answered by AI

Where is this study being done?

"This study is still looking for participants at 5 sites. If you live near Houston, Sugar Land, or The Woodlands; then consider enrolling as those will require the least amount of travel."

Answered by AI

What is the official position of the FDA on Tretinoin?

"While Phase 2 trials don't have data supporting efficacy, there is some evidence that suggests Tretinoin is safe. We've given it a score of 2."

Answered by AI

Are there any available positions for participants in this trial?

"The website clinicaltrials.gov says that this particular trial is still opening up spots for patients. The trial was first announced on October 5th, 2011 and the most recent update was on September 28th, 2020."

Answered by AI

Can you provide some context for Tretinoin's efficacy?

"As of the current moment, there are 62 different clinical trials studying Tretinoin. 9 of those active studies are in their third stage. Most of the research is being conducted in New york City; however, there are 846 locations running trials for this treatment worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2011. "Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01409161.

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