RecruitingPhase 2NCT01409161

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)


Sponsor

M.D. Anderson Cancer Center

Enrollment

151 participants

Start Date

Oct 5, 2011

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of cancer drugs — tretinoin (a vitamin A derivative), arsenic trioxide, and possibly a third drug called gemtuzumab ozogamicin — in people newly diagnosed with a type of leukemia called acute promyelocytic leukemia (APL), a fast-moving blood cancer. **You may be eligible if...** - You have been newly diagnosed with acute promyelocytic leukemia (APL), confirmed by genetic testing - You are able to understand and sign an informed consent form - You may have already started emergency treatment with some of these drugs before enrolling **You may NOT be eligible if...** - Your APL diagnosis has not been confirmed by the required genetic tests - You are unable to provide informed consent - You have had prior treatment for APL beyond what is allowed (some early emergency treatment is permitted) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGArsenic Trioxide

Given IV

DRUGGemtuzumab Ozogamicin

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies

DRUGTretinoin

Given PO


Locations(5)

M D Anderson Cancer Center

Houston, Texas, United States

MD Anderson Regional Care Center-Katy

Houston, Texas, United States

MD Anderson Regional Care Center-Bay Area

Nassau Bay, Texas, United States

MD Anderson Regional Care Center-Sugar Land

Sugar Land, Texas, United States

MD Anderson Regional Care Center-The Woodlands

The Woodlands, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT01409161


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