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NCT01409161Possibly a fitRecruiting

Tretinoin and arsenic drugs for newly diagnosed acute promyelocytic leukemia

Acute Promyelocytic Leukemia With PML-RARA

Treatments studied

Part of Blood & lymphatic, Cancer clinical trials.

This trial studies how well a combination of tretinoin (ATRA) and arsenic trioxide (ATO)—with or without another antibody-like drug called gemtuzumab—treats people with newly diagnosed acute promyelocytic leukemia (APL). The goal is to see if these medicines work better together and are safe.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
151 people
Ages
10 years and older
Study type
Interventional

Who can take part

  • Your leukemia diagnosis must be confirmed as APL using a specific gene test (PML-RAR-alpha fusion)
  • You must be able to read, understand, and sign consent to join a research study
  • If you already started urgent APL treatment (ATRA, ATO, and/or one dose of idarubicin), you may still be eligible
  • If you can become pregnant, you must have a negative pregnancy blood test at screening and again within 48 hours before starting study drugs
  • You must agree to use two reliable birth-control methods during the study if you are sexually active and pregnancy is possible
  • Before starting, your heart rhythm test (EKG) must not show a QTcF value above 480 milliseconds

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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