Study on Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin for Treating Newly Diagnosed Acute Promyelocytic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01409161

Provider View

This clinical trial is exploring how well a combination of tretinoin and arsenic trioxide, with or without gemtuzumab ozogamicin, works in treating patients who have not yet received treatment for acute promyelocytic leukemia (APL). The study aims to see if these drugs can effectively stop cancer cell growth and improve patient outcomes.

Patient Parameters

Program Overview

This study is testing whether a combination of tretinoin and arsenic trioxide, with or without gemtuzumab ozogamicin, can effectively treat patients with newly diagnosed acute promyelocytic leukemia (APL). Tretinoin and arsenic trioxide are chemotherapy drugs that work by stopping cancer cells from growing and spreading. Gemtuzumab ozogamicin is an immunotoxin that targets and kills specific cancer cells without harming normal cells. The study aims to determine if using these drugs together can kill more cancer cells and improve treatment results.

Description

The study has two main goals:

  1. To see if a combination of tretinoin (also known as all-trans retinoic acid or ATRA) and arsenic trioxide (ATO) can help patients with low-risk acute promyelocytic leukemia (APL) live longer without events like cancer returning.

  2. To find out if adding gemtuzumab ozogamicin (GO) at the start of treatment for patients with high-risk APL (those with a white blood cell count over 10,000) or if their white blood cell count rises above 10,000 after starting treatment, can improve the complete response rate without causing more side effects.

Treatment Plan:

  • Induction Phase: Patients will take tretinoin by mouth twice a day, receive arsenic trioxide through an IV drip over 1-2 hours daily, and get gemtuzumab ozogamicin through an IV drip over 2 hours once a week for the first 4 weeks.

  • Consolidation Phase: Patients who achieve a complete response will receive arsenic trioxide through an IV drip 5 days a week during weeks 1-4, 9-12, 17-20, and 25-28. They will also take tretinoin by mouth twice a day for 2 weeks on and 2 weeks off. This treatment cycle repeats every 8 weeks for up to 4 courses, as long as the disease does not progress and side effects are manageable.

After finishing the study treatment, patients will have follow-up visits every 6-12 months to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with acute promyelocytic leukemia (APL) confirmed by specific genetic tests.
  • Able to understand and willing to sign a consent form acknowledging the study's investigational nature.
  • Patients who have already started emergency treatment for APL with tretinoin, arsenic trioxide, or one dose of idarubicin are eligible.
  • Women who can become pregnant must have a negative pregnancy test at screening and again within 48 hours before starting the study drug.
  • All sexually active participants must agree to use two effective methods of birth control during the study.

Exclusion Criteria

  • Have a heart rhythm issue with a QTcF interval over 480 milliseconds on an EKG.
  • Have kidney function tests showing creatinine levels more than 2.5 times the normal limit, unless related to leukemia or other specific conditions.
  • Have liver function tests showing total bilirubin levels 2.0 times the normal limit or higher, unless related to leukemia or other specific conditions.
  • Have liver enzymes (ALT/AST) more than 3 times the normal limit, unless related to leukemia or other specific conditions.

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