Phase
Condition
Leukemia
Multiple Myeloma
Platelet Disorders
Treatment
Cytarabine
Dexrazoxane Hydrochloride
Idarubicin
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Baseline left ventricular ejection fraction (LVEF) is greater than or equal to 50%by echocardiography (echo) or multigated acquisition (MUGA) scan.
Patients of child bearing potential should use contraception.
Patients with a diagnosis of acute myeloid leukemia (AML), or high riskmyelodysplastic syndrome (MDS) (>= 10% blasts or International Prognostic ScoringSystem [IPSS] >= intermediate-2) or high-risk myeloproliferative neoplasm will beeligible.
Patients with untreated or previously untreated chronic myeloid leukemia (CML) inmyeloid blast phase or (Philadelphia chromosome-positive (Ph+) AML are alsoeligible.
Patients with myeloproliferative neoplasms in blast phase will be eligible.
Patients with isolated extramedullary myeloid neoplasm will be eligible.
Patients with active CNS (central nervous system) disease are eligible.
Bilirubin < 2mg/dL.
AST (aspartate aminotransferase) and/or ALT (alanine aminotransferase) < 3 x ULN (upper limit of normal) - or < 5 x ULN if related to leukemic involvement.
Creatinine < 1.5 x ULN.
Hyperbilirubinemia is allowed if due to Gilbert's hyperbilirubinemia.
A negative urine pregnancy test is required within 1 week for all women ofchildbearing potential prior to enrolling on this trial.
Women of childbearing potential and men must agree to use contraception prior tostudy entry and for the duration of study participation.
Patient must have the ability to understand the requirements of the study and signedinformed consent. A signed informed consent by the patient or his legally authorizedrepresentative is required prior to their enrollment on the protocol.
Prior therapy for any of the cohorts may include with hydroxyurea, rescue doses ofcytarabine, various combination-chemotherapy regimens, hematopoietic growth factors,azacytidine, decitabine, ATRA (all-trans retinoic acid).
Cohort 1: Frontline cohort patients are eligible in the frontline cohort if they areuntreated or previously treated already in CR if they received 3 or fewer cycles ofprevious chemotherapy (including either 1 induction and 2 consolidations or 2inductions and 1 consolidation).
Cohort 2: Salvage cohort in 1st and 2nd salvage patients are eligible in the salvagecohort 2 if they have active disease after first or second relapse or if they are inCR after previously documented first or second relapse as long as they if they havereceived 3 or fewer cycles of chemotherapy to achieve the most current CR.
Cohort 3: Salvage cohort in 3rd salvage and beyond patients may be eligible insalvage cohort 3 if they have active disease after 3rd or greater relapse or if theyare in CR after a previously documented relapse (3rd or greater), but may have onlyreceived 3 or fewer cycles of chemotherapy to achieve the most current CR.
Cohort 4: Maintenance cohort: Patients in CR who are considered by treatingphysician to benefit from maintenance therapy are eligible for maintenance therapywith dexrazoxane combined with idarubicin plus cytarabine.
Exclusion
Exclusion Criteria:
Any condition, including the presence of laboratory abnormalities, which judged bythe investigator, places the patient at unacceptable risk.
Active heart disease defined as: Unstable coronary syndromes, unstable or severeangina, recent myocardial infarction (MI) within 6 months.
Decompensated heart failure (HF).
Clinically significant arrhythmias.
Severe valvular disease.
History of coronary artery disease (CAD).
Pregnant women are excluded from this study because the agents used in this studyhave the potential for teratogenic or abortifacient effects. Because there is apotential risk for adverse events in nursing infants secondary to treatment of themother with the chemotherapy agents, breastfeeding should also be avoided.
Psychiatric illness/social situations that would limit compliance with studyrequirements per the judgment of the investigator.
Patient with documented hypersensitivity to any of the components of thechemotherapy program.
Men and women of childbearing potential who do not practice contraception.
Study Design
Study Description
Connect with a study center
M D Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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