Tretinoin, Cytarabine, and Daunorubicin Hydrochloride With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia
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| ClinicalTrials.gov Identifier: NCT00003934 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 5, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Promyelocytic Leukemia (M3) Childhood Acute Promyelocytic Leukemia (M3) Untreated Adult Acute Myeloid Leukemia Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies | Drug: tretinoin Drug: daunorubicin hydrochloride Drug: cytarabine Drug: mercaptopurine Drug: methotrexate Drug: arsenic trioxide | Phase 3 |
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 420 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC # 706363) as Initial Consolidation Therapy Followed by Maintenance Therapy With Intermittent Tretinoin Versus Intermittent Tretinoin Plus Mercaptopurine and Methotrexate for Patients With Untreated Acute Promyelocytic Leukemia |
| Study Start Date : | June 1999 |
| Actual Primary Completion Date : | November 2006 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I
Induction: All patients receive oral tretinoin every 12 hours beginning on day 1 until complete response or for a maximum of 90 days. Patients also receive daunorubicin IV on days 3-6 and cytarabine IV continuously on days 3-9. Consolidation: All patients achieving CR or PR after completion of tretinoin, proceed to consolidation within 2 weeks of achieving CR or PR, but not prior to 30 days from the start of induction. Patients are randomized to 1 of 2 treatment arms. Patients receive oral tretinoin every 12 hours on days 1-7 and daunorubicin IV on days 1-2 or days 1-3, depending on age. Patients may receive an additional course. Treatment begins no earlier than 2 weeks and no later than 4 weeks after hematopoietic recovery. |
Drug: tretinoin
Given orally
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: arsenic trioxide Given IV
Other Names:
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Experimental: Arm II
Induction: All patients receive oral tretinoin every 12 hours beginning on day 1 until complete response or for a maximum of 90 days. Patients also receive daunorubicin IV on days 3-6 and cytarabine IV continuously on days 3-9. Consolidation: All patients achieving CR or PR after completion of tretinoin, proceed to consolidation within 2 weeks of achieving CR or PR, but not prior to 30 days from the start of induction. Patients are randomized to 1 of 2 treatment arms. Patients receive oral tretinoin as in arm I above. Patients also receive oral mercaptopurine once a day and oral methotrexate once weekly for up to 1 year. |
Drug: tretinoin
Given orally
Other Names:
Drug: daunorubicin hydrochloride Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Drug: mercaptopurine Given IV
Other Names:
Drug: methotrexate Given IV
Other Names:
Drug: arsenic trioxide Given IV
Other Names:
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- Response rates [ Time Frame: Up to 10 years ]
- Distributions of event-free survival [ Time Frame: Up to 10 years ]
- Disease-free survival [ Time Frame: Time from the date of the maintenance randomization to relapse or death, assessed up to 10 years ]
- Survival [ Time Frame: Up to 10 years ]
- Toxicities for the various therapies graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to 30 days after last dose of study treatment ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have a clinical diagnosis of acute promyelocytic leukemia (APL) with proof of APL morphology (FAB-M3) confirmed by RT-PCR assay; a patient may be entered prior to completion of RT-PCR studies, but a patient who is subsequently found to be PML-RARα negative and RARα-PML negative will be removed from protocol treatment
- FAB clasification: the aspirate smear must show M3 characteristics and at least 30% of cells must be abnormal promyelocytes with heavy granulation; the overall marrow cellularity must be normocellular or hypercellular; patients with the microgranular variant (M3V) are eligible, and the diagnosis will be based on characteristic morphologic findings (e.g., reniform or bilobed nuclei)
- RT-PCR assay: submission of samples for RT-PCR assays for PML-RARα/RARα-PML transcripts is mandatory; the results do not have to be known prior to initiation of therapy; if the assay is subsequently found to be negative, the patient will be removed from protocol treatment and treated at the discretion of the responsible physician
- Prior treatment: the patient must not have received any systemic definitive treatment for APL, including cytotoxic chemotherapy or retinoids; prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient
- Non-pregnant, non-nursing: treatment under this protocol would expose an unborn child to significant risks; patients should not be pregnant or plan to become pregnant while on treatment; women and men of reproductive potential should agree to use an effective means of birth control; there is an extremely high risk of fetal malformation if pregnancy occurs while on ATRA in any amount even for short periods
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003934
| United States, Illinois | |
| Cancer and Leukemia Group B | |
| Chicago, Illinois, United States, 60606 | |
| United States, North Carolina | |
| Comprehensive Cancer Center of Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Bayard Powell | Cancer and Leukemia Group B |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003934 |
| Other Study ID Numbers: |
NCI-2012-02811 C9710 CDR0000067126 CALGB-C9710 U10CA031946 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | June 5, 2013 |
| Last Verified: | June 2013 |
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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Promyelocytic, Acute Neoplasms by Histologic Type Neoplasms Cytarabine Methotrexate Mercaptopurine Daunorubicin Arsenic Trioxide Tretinoin Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Antiviral Agents Anti-Infective Agents Antibiotics, Antineoplastic |