Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers
Cardioprotection With Dexrazoxane in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), Myeloid Blast Phase of Chronic Myeloid Leukemia (CML), Ph+ AML, and Myeloid Blast Phase of Myeloproliferative Neoplasms
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 32 months
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "To study environmental exposure data based on an environmental health assessment survey."
- "Courses repeat every 3-7 weeks for 32 months in the absence of disease progression or unacceptable toxicity."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This phase II study tests whether dexrazoxane hydrochloride can help protect the heart from damage caused by chemotherapy. It is for people with certain blood cancers, including leukemia and high-risk bone marrow diseases.
This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in participants with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect the heart from the side effects of drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin, in participants with blood cancers.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have an eligible blood cancer: acute myeloid leukemia (AML), high-risk myelodysplastic syndrome, or a high-risk myeloproliferative neoplasm. These diseases affect blood-forming cells.
- Other eligible cancers include untreated chronic myeloid leukemia in myeloid blast phase (an advanced stage), Philadelphia chromosome-positive AML, myeloproliferative neoplasms in blast phase, and myeloid cancer found only outside the bone marrow. Cancer in the brain or spinal cord is allowed.
- A heart scan must show that the heart's main pumping chamber pumps out at least 50% of its blood with each beat.
- Meet liver and kidney blood test limits: bilirubin below 2 mg/dL, AST or ALT below 3 times the normal upper limit, and creatinine below 1.5 times that limit. AST or ALT may be below 5 times that limit if leukemia is the cause. High bilirubin from Gilbert's condition is allowed.
- For the first-treatment group, be untreated or in complete remission after no more than 3 chemotherapy cycles. Complete remission means there are no signs of cancer on standard tests.
- For groups whose cancer has returned, have active cancer or be in complete remission after no more than 3 chemotherapy cycles for the latest remission. For the maintenance group, be in complete remission and have a doctor who thinks ongoing treatment may help.
- If able to become pregnant, have a negative urine pregnancy test within 1 week before joining. Men and women who could have a child must agree to use birth control before joining and throughout the study.
- Be able to understand the study requirements. You or your legally authorized representative must sign a consent form before you join.
Who can't join
- Have any condition or abnormal test result that the study doctor believes makes treatment too risky.
- Have unstable heart artery disease, unstable or severe chest pain, or a heart attack within the past 6 months.
- Have heart failure that is not under control, a serious abnormal heartbeat, or severe heart valve disease.
- Have a history of coronary artery disease, which affects the arteries that supply blood to the heart.
- Be pregnant. Breastfeeding should also be avoided because treatment may harm a nursing baby.
- Have a mental health condition or life situation that the study doctor believes would prevent you from following study requirements.
- Have a known allergy to any part of the chemotherapy treatment.
- Be able to have a child but not use birth control.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 risk myelodysplastic syndrome (MDS) (\>= 10% blasts or International Prognostic Scoring System \[IPSS\] \>= intermediate-2) or high-risk myeloproliferative neoplasm will be eligible. * Patients with untreated or previously untreated chronic myeloid leukemia (CML) in myeloid blast phase or (Philadelphia chromosome-positive (Ph+) AML are also eligible. * 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 of childbearing potential prior to enrolling on this trial. * Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. * Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol. * Prior therapy for any of the cohorts may include with hydroxyurea, rescue doses of cytarabine, 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 are untreated or previously treated already in CR if they received 3 or fewer cycles of previous chemotherapy (including either 1 induction and 2 consolidations or 2 inductions and 1 consolidation). * Cohort 2: Salvage cohort in 1st and 2nd salvage patients are eligible in the salvage cohort 2 if they have active disease after first or second relapse or if they are in CR after previously documented first or second relapse as long as they if they have received 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 in salvage cohort 3 if they have active disease after 3rd or greater relapse or if they are in CR after a previously documented relapse (3rd or greater), but may have only received 3 or fewer cycles of chemotherapy to achieve the most current CR. * Cohort 4: Maintenance cohort: Patients in CR who are considered by treating physician to benefit from maintenance therapy are eligible for maintenance therapy with dexrazoxane combined with idarubicin plus cytarabine. Exclusion Criteria: * Any condition, including the presence of laboratory abnormalities, which judged by the investigator, places the patient at unacceptable risk. * Active heart disease defined as: Unstable coronary syndromes, unstable or severe angina, 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 study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided. * Psychiatric illness/social situations that would limit compliance with study requirements per the judgment of the investigator. * Patient with documented hypersensitivity to any of the components of the chemotherapy program. * Men and women of childbearing potential who do not practice contraception.
Study sites (1)
TX
- M D Anderson Cancer Center · Houston, TX 77030Maro Ohanian · Study contact · 713-792-2631Maro Ohanian · Principal investigatorMore trials in Houston