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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00413166
First received: December 15, 2006
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Acute Promyelocytic Leukemia
Drug: All-Trans Retinoic Acid (ATRA)
Drug: Arsenic Trioxide (ATO)
Drug: Idarubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Acute Promyelocytic Leukemia (APL) With All-Trans Retinoic Acid, and Arsenic +/- Gemtuzumab

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Complete Response (CR) Rate [ Time Frame: Daily during 7 days of induction, then 2 times weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2006
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction

All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO)

ATRA 45 mg/m2 daily by mouth beginning day 1; ATO 0.15 mg/kg by vein daily beginning on day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days starting on day 1.

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.
Other Name: Idamycin
Experimental: Maintenance

All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO)

ATO 0.15 mg/kg by vein over 2 hours Monday-Friday for 4 weeks, then a 4-week break. ATRA 45 mg/m2 by mouth every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.

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.
Other Name: Idamycin

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene by cytogenetics, PCR, or POD test.
  2. Provision of written informed consent.
  3. Patients in whom therapy for APL was initiated on an emergent basis are eligible

Exclusion Criteria:

  1. First trimester of pregnancy (ATRA is teratogenic)
  2. QTC interval must not be greater than 480 milliseconds.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413166

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Farhad Ravandi-Kashani, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00413166     History of Changes
Other Study ID Numbers: 2006-0706, NCI-2012-01395
Study First Received: December 15, 2006
Last Updated: October 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Acute Promyelocytic Leukemia
APL
ATRA
All-Trans Retinoic Acid
Arsenic Trioxide
Theophylline
Gemtuzumab

Additional relevant MeSH terms:
Arsenic trioxide
Leukemia
Leukemia, Promyelocytic, Acute
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Gemtuzumab
Idarubicin
Tretinoin
Antibiotics, Antineoplastic
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Keratolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014