Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
This study has suspended participant recruitment.
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00866918
First received: March 20, 2009
Last updated: November 7, 2012
Last verified: November 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® IND #103331) During Consolidation |
Resource links provided by NLM:
Genetics Home Reference related topics:
acute promyelocytic leukemia
familial acute myeloid leukemia with mutated CEBPA
Drug Information available for:
Mercaptopurine
Methotrexate
Cytarabine
Tretinoin
Arsenic trioxide
Arsenic
Methotrexate sodium
Idarubicin hydrochloride
Idarubicin
Mitoxantrone
Mitoxantrone hydrochloride
U.S. FDA Resources
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: | 132 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | June 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) (bone marrow or peripheral blood)
- Bone marrow is highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral blood will be accepted
- 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 or peripheral blood 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 or other suspected leukemia, including cytotoxic chemotherapy, retinoids, or arsenic
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866918
Show 111 Study Locations
Show 111 Study LocationsSponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | John J. Gregory, MD | Goryeb Children's Hospital at Morristown Memorial Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00866918 History of Changes |
| Other Study ID Numbers: | CDR0000637184, COG-AAML0631 |
| Study First Received: | March 20, 2009 |
| Last Updated: | November 7, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
childhood acute promyelocytic leukemia (M3) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Promyelocytic, Acute Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid, Acute Leukemia, Myeloid 6-Mercaptopurine Cytarabine Methotrexate Arsenic trioxide Idarubicin Mitoxantrone Tretinoin Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Antiviral Agents Anti-Infective Agents Antibiotics, Antineoplastic Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 19, 2013