Acute Promyelocytic Leukemia (APL) Treated With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01409161
First received: August 2, 2011
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

The goal of this clinical research study is to learn if the combination of all-trans retinoic acid (ATRA), arsenic trioxide (ATO), and gemtuzumab ozogamicin (GO) can help to control APL. The safety of this drug combination will also be studied.


Condition Intervention Phase
Leukemia
Drug: ATRA
Drug: ATO
Drug: GO (Gemtuzumab ozogamicin)
Drug: Methylprednisolone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Event Free Survival (EFS) [ Time Frame: Day 21-28 ] [ Designated as safety issue: No ]
    Time from start of treatment to first documentation of disease relapse or death. For each risk group, Bayesian time-to-event model used to monitor the event free survival (EFS) time.


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATRA + ATO
Induction: All-trans retinoic acid (ATRA) 45 mg/m2 daily orally and Arsenic trioxide (ATO) 0.15 mg/kg by vein daily beginning on day 1 with Gemtuzumab ozogamicin (GO) 9 mg/m2 by vein. Methylprednisolone 50 mg by vein daily for 5 days followed by rapid taper starting on day 6 (Induction).
Drug: ATRA
45 mg/m2 daily by mouth beginning Day 1 (in 2 divided doses approximately 12 hours apart) for Course 1 (Induction) and during Weeks 1-2 and 5-6 of Courses 2-5 (Consolidation).
Other Names:
  • Tretinoin (oral)
  • All-trans retinoic acid
  • Vesanoid
Drug: ATO
0.15 mg/kg by vein over 1 hour (+/- 10 minutes) daily beginning on day 1, Course 1 (Induction) then over 1-2 hours for 5 days total during Weeks 1-4 of Courses 2-5 (Consolidation). Each course is about 8 weeks.
Other Names:
  • Arsenic trioxide
  • Trissenox
Drug: GO (Gemtuzumab ozogamicin)
9 mg/m2 by vein may be given one time during weeks 1-4 (Induction).
Other Names:
  • Gemtuzumab ozogamicin
  • Mylotarg
Drug: Methylprednisolone
50 mg by vein daily for 5 days followed by rapid taper starting on day 6 (Induction).
Other Names:
  • Depo-Medrol
  • Medrol
  • Solu-Medrol

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years and older
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. 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. Patients age 10 years and older are eligible.
  5. 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.
  6. 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.

Exclusion Criteria:

  1. QTcF interval on the EKG greater than 480 milliseconds.
  2. Patients with creatinine > 2.5 and total bilirubin >/= 2.0 and ALT/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
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: NCT01409161

Contacts
Contact: Farhad Ravandi-Kashani, MD 713-745-0394

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01409161     History of Changes
Other Study ID Numbers: 2010-0981, NCI-2011-02767
Study First Received: August 2, 2011
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Acute Promyelocytic Leukemia
APL
ATRA
Tretinoin
All-trans retinoic acid
Vesanoid
ATO
Arsenic trioxide
Trisenox
GO
Gemtuzumab
Mylotarg
Gemtuzumab ozogamicin
Methylprednisolone
Depo-Medrol
Medrol
Solu-Medrol

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Arsenic trioxide
Gemtuzumab
Tretinoin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 28, 2014