RecruitingPhase 2

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

Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test * Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study * Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and/or one dose of idarubicin due to the urgency to start therapy early) * Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug * 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 Exclusion Criteria: * Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds * Patients with creatinine \> 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease * Patients with total bilirubin \>= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease * Patients with alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \> 3 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease

Study sites (5)

TX

  • M D Anderson Cancer Center · Houston, TX 77030Farhad Ravandi-Kashani · Study contact · 713-745-0394Farhad Ravandi-Kashani · Principal investigatorMore trials in Houston
  • MD Anderson Regional Care Center-Katy · Houston, TX 77094Farhad Ravandi-Kashani · Study contact · 713-745-0394Farhad Ravandi-Kashani · Principal investigatorMore trials in Houston
  • MD Anderson Regional Care Center-Bay Area · Nassau Bay, TX 77058Farhad Ravandi-Kashani · Study contact · 713-745-0394Farhad Ravandi-Kashani · Principal investigatorMore trials in Nassau Bay
  • MD Anderson Regional Care Center-Sugar Land · Sugar Land, TX 77478Farhad Ravandi-Kashani · Study contact · 713-745-0394Farhad Ravandi-Kashani · Principal investigatorMore trials in Sugar Land
  • MD Anderson Regional Care Center-The Woodlands · The Woodlands, TX 77384Farhad Ravandi-Kashani · Study contact · 713-745-0394Farhad Ravandi-Kashani · Principal investigatorMore trials in The Woodlands