Is NCT03589729 recruiting in Houston, TX?

Yes, NCT03589729 is currently recruiting participants at its Houston, TX location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Myeloid Leukemia Clinical Trial in Houston, TX

About This Acute Myeloid Leukemia Study in Houston

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.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT03589729) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia Treatment Options in Houston, TX

If you're searching for acute myeloid leukemia treatment options in Houston, TX, this clinical trial (NCT03589729) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute myeloid leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Houston, TX

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