Acute Promyelocytic Leukemia (APL) Treated With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin
This study is currently recruiting participants.
Verified June 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01409161
First received: August 2, 2011
Last updated: June 11, 2013
Last verified: June 2013
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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:
Genetics Home Reference related topics:
acute promyelocytic leukemia
familial acute myeloid leukemia with mutated CEBPA
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Tretinoin
Arsenic trioxide
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Arsenic
Gemtuzumab ozogamicin
U.S. FDA Resources
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:
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:
Drug: GO (Gemtuzumab ozogamicin)
9 mg/m2 by vein may be given one time during weeks 1-4 (Induction).
Other Names:
Drug: Methylprednisolone
50 mg by vein daily for 5 days followed by rapid taper starting on day 6 (Induction).
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, PCR, or POD test.
- 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.
- 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).
- Patients age 10 years and older are eligible.
- 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.
- 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:
- QTc interval on the EKG greater than 480 milliseconds by any correction.
- 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
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 |
| Study First Received: | August 2, 2011 |
| Last Updated: | June 11, 2013 |
| 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 June 17, 2013