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Clinical Trial COGAAML1331

Title

A Phase III Study for Patients with Newly Diagnosed Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide and All-Trans Retinoic Acid

Principal Investigator(s)

Debra Friedman

Details

  • Protocol No. COGAAML1331
  • Open Date: 04/28/2016
  • Staging: Phase III
  • Age Group: Both Child and Adult
  • Scope: National
  • Objective: 1.To eliminate exposure to conventional chemotherapy (including anthracyclines), for patients with standard risk APL, through use of ATO and ATRA based therapy while achieving an event free survival (EFS) that is not inferior compared to historical controls. 2. To significantly reduce exposure to conventional chemotherapy, and in particular, anthracycline exposure, for patients with high risk APL, through use of ATO and ATRA based therapy while achieving an event free survival that is not inferior compared to historical controls.
  • Disease Sites: Leukemia; Pediatric Leukemia
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Arsenic Trioxide; Cytarabine (ARA-C); Dexamethasone; Hydrocortisone; Idarubicin; Leucovorin; Methotrexate; Mitoxantrone; Tretinoin (ATRA)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02339740
  • Secondary Protocol No: AAML1331

Description

None Provided.

Eligibility

Ages Eligible for Study:1 Year to 21 Years
Genders Eligible for Study:All
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Patients must be newly diagnosed with a clinical diagnosis of APL (initially by morphology of 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 RQ-PCR results are known at the time of study enrollment, the patient must demonstrate the PML-RARalpha transcript by RQ-PCR to be eligible
• NOTE: A lumbar puncture is not required in order to be enrolled on study nor are lumbar punctures recommended at the time of diagnosis; if the diagnosis of APL is known or suspected, diagnostic lumbar punctures in patients with neurologic symptoms should be deferred until any coagulopathy is corrected; if central nervous system (CNS) disease is suspected or proven, a computed tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out the possibility of an associated chloroma; if CNS disease is documented, patients are still eligible and will receive protocol directed intrathecal treatments
• Patients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to administration of protocol therapy
• Treatment with hydroxyurea, corticosteroids (any route) and intrathecal cytarabine prior to beginning protocol directed therapy is allowed; however, it should be noted that lumbar puncture and intrathecal therapy at initial diagnosis of APL is not recommended
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
• Patients with secondary APL are excluded; this includes all patients with APL that may have resulted from prior treatment (chemotherapy or radiation)
• Patients with isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) but without evidence of APL by bone marrow or peripheral blood morphology are excluded
• Patients with a pre-existing diagnosis of a prolonged QT syndrome (even if corrected QT interval [QTc] is normal at the time of APL diagnosis) are excluded
• Patients with a baseline QTc of > 450 msec are excluded; Bazett's formula is to be used for measurement of the corrected QT interval: the QT interval (msec) divided by the square root of the RR interval (msec)
• Patients with a history or presence of significant ventricular or atrial tachyarrhythmia are excluded
• Patients with right bundle branch block plus left anterior hemiblock, bifascicular block are excluded
• Patients with serum creatinine > 3.0 mg/dL and patients on active dialysis for renal dysfunction are excluded
• Patients who have received treatment with any other cytotoxic chemotherapy prior to beginning protocol therapy (other than allowed in above criteria) are excluded
• Female patients who are pregnant are exclude; patients should not be pregnant or plan to become pregnant while on treatment; a pregnancy test prior to enrollment is required for female patients of childbearing potential
• Lactating females who plan to breastfeed their infants are excluded
• Sexually active patients of reproductive potential who have not agreed to be abstinent or use 2 forms of effective contraception during treatment through 1 month off therapy are excluded