Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), May 2009

First Received: March 20, 2009 Last Updated: May 2, 2009 History of Changes

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00866918

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia.

Condition	Intervention	Phase
Leukemia	Drug: arsenic trioxide Drug: cytarabine Drug: idarubicin Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: tretinoin Genetic: cytogenetic analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis	Phase III

MedlinePlus related topics: Arsenic Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: 6-Mercaptopurine Methotrexate Cytarabine hydrochloride Idarubicin hydrochloride Idarubicin Mitoxantrone Mitoxantrone hydrochloride Cytarabine Tretinoin Arsenic trioxide Mercaptopurine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® IND #103331) During Consolidation

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hematologic, molecular, and cytogenetic remission rates after each phase of therapy [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Percentage of patients experiencing grade 3 or 4 toxicity, or cardiac toxicity of any grade [ Designated as safety issue: Yes ]
Time to blood count recovery [ Designated as safety issue: No ]
Duration of hospitalization [ Designated as safety issue: No ]

Estimated Enrollment:	86
Study Start Date:	March 2009
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	2 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

New clinically and morphologically confirmed diagnosis of acute promyelocytic leukemia (APL)
If the real-time quantitative (RQ)-PCR results are known, the patient must demonstrate PML-RARA and/or RARA-PML transcripts by RQ-PCR
Patients without evidence of APL by bone marrow morphology but with isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis) are eligible provided that the t(15;17) translocation is documented on either marrow or tumor tissue by cytogenetics, FISH, or PCR prior to study enrollment (in this situation, touch preps from the tumor site can be evaluated by FISH with PML-RARA probes)

PATIENT CHARACTERISTICS:

No minimal performance status criteria
Not pregnant or nursing
Fertile patients must use effective contraception
No pre-existing prolonged QT syndrome

PRIOR CONCURRENT THERAPY:

Prior intrathecal cytarabine prior to the diagnosis of acute promyelocytic leukemia (APL) allowed
Prior corticosteroids, hydroxyurea, and leukapheresis allowed
No prior systemic definitive treatment for APL, including cytotoxic chemotherapy, retinoids, or arsenic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866918

Locations

United States, California
Children's Hospital Central California	Recruiting
Madera, California, United States, 93638-8762
Contact: Vonda L. Crouse 559-353-5480
UCSF Helen Diller Family Comprehensive Cancer Center	Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222
United States, Florida
Lee Cancer Care of Lee Memorial Health System	Recruiting
Fort Myers, Florida, United States, 33901
Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt 877-680-0008
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky	Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432
United States, Oklahoma
Oklahoma University Cancer Institute	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp 405-271-5311

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

John J. Gregory, MD

Goryeb Children's Hospital at Morristown Memorial Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers:	CDR0000637184, COG-AAML0631
Study First Received:	March 20, 2009
Last Updated:	May 2, 2009
ClinicalTrials.gov Identifier:	NCT00866918 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

childhood acute promyelocytic leukemia (M3)

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Arsenic trioxide
Leukemia, Myeloid
6-Mercaptopurine
Folic Acid Antagonists
Leukemia, Myeloid, Acute
Antiviral Agents
Immunosuppressive Agents
Folic Acid
Anti-Bacterial Agents

Leukemia
Idarubicin
Leukemia, Promyelocytic, Acute
Methotrexate
Tretinoin
Peripheral Nervous System Agents
Analgesics
Mitoxantrone
Antirheumatic Agents
Acute Promyelocytic Leukemia
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
6-Mercaptopurine
Antibiotics, Antineoplastic
Leukemia, Myeloid, Acute
Leukemia
Sensory System Agents
Therapeutic Uses
Abortifacient Agents

Leukemia, Promyelocytic, Acute
Methotrexate
Analgesics
Dermatologic Agents
Cytarabine
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Arsenic trioxide
Enzyme Inhibitors
Leukemia, Myeloid
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009