CompletedPhase 2

Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia

United StatesStarted 2004-10

Plain-language summary

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 II trial is studying how well giving combination chemotherapy works in treating patients with acute promyelocytic leukemia.

Who can participate

Age range5 Years – 74 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Diagnosis of acute promyelocytic leukemia (APL) by morphologic and flow cytometric documentation (high orthogonal light scatter, lack of HLA-DR expression) * Patients with classical APL as well as the microgranular variant (M3V) are eligible * In cases where the diagnosis is unclear, consultation with a hematopathologist is required before enrolling the patient in the study * Patients found to have cytogenetic abnormalities that do not produce the PML-RARα gene rearrangement will be removed from study and will not be included in data analysis PATIENT CHARACTERISTICS: * Patients will not be excluded because of performance status or comorbid disease * Premenopausal female patients must have a negative pregnancy test PRIOR CONCURRENT THERAPY: * No prior chemotherapy for APL except hydroxyurea

What they're measuring

Disease-free survival at 2 and 5 years after study completion

Safety of arsenic trioxide following cytarabine and anthracycline immediately after study completion

Trial details

NCT IDNCT00276601

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-12

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