RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2011-10-05
Study Completion:2025-12-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01409161

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test
  2. * 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
  3. * 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)
  4. * 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
  5. * 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
  1. * Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds
  2. * 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
  3. * 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
  4. * 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

Contacts and Locations

Study Contact

Farhad Ravandi-Kashani
CONTACT
713-745-0394
fravandi@mdanderson.org

Principal Investigator

Farhad Ravandi-Kashani
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States
MD Anderson Regional Care Center-Katy
Houston, Texas, 77094
United States
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, 77058
United States
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, 77478
United States
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, 77384
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Farhad Ravandi-Kashani, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-10-05
Study Completion Date2025-12-18

Study Record Updates

Study Start Date2011-10-05
Study Completion Date2025-12-18

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Promyelocytic Leukemia With PML-RARA