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All-trans Retinoic Acid, and Arsenic +/- Idarubicin

NCT00413166 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2019-05-07

Study results available
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Summary

The goal of this clinical research study is to learn if the combination of arsenic trioxide (ATO) with ATRA and possibly idarubicin is effective in treating patients with newly-diagnosed APL.

Conditions

  • Acute Promyelocytic Leukemia

Interventions

DRUG

All-Trans Retinoic Acid (ATRA)

Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1

DRUG

Arsenic Trioxide (ATO)

Induction: 0.15 mg/kg daily IV beginning day 1

DRUG

Idarubicin

1. 12 mg/m2 one dose only (may be given on day 1 to 5 of induction) 2. If either ATRA or ATO are discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses will be administered once every 4 to 5 weeks (depending on the recovery of counts) until 28 weeks has elapsed from the Complete Recovery date.

DRUG

Gemtuzumab Ozogamicin

Induction: 9 mg/m2 on day 1 of induction

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00413166 on ClinicalTrials.gov