Is NCT02074839 recruiting in Los Angeles, CA?

Yes, NCT02074839 is currently recruiting participants at its Los Angeles, CA location. This relapsed or refractory acute myeloid leukemia (aml) clinical trial is actively enrolling qualified participants.

Is participation in this Los Angeles 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.

Relapsed or Refractory Acute Myeloid Leukemia (AML) Clinical Trial in Los Angeles, CA

Q: How do I join the relapsed or refractory acute myeloid leukemia (aml) clinical trial in Los Angeles?

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

About This Relapsed or Refractory Acute Myeloid Leukemia (AML) Study in Los Angeles

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Sponsor: Institut de Recherches Internationales Servier

Who Can Participate

Inclusion Criteria

Subject must be ≥18 years of age.

Subjects must have documented IDH1 R132 gene-mutated advanced hematologic malignancy based on local or central evaluation.

Subjects must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study.

Subjects must have ECOG PS of 0 to 2.

Platelet count ≥20,000/µL (Transfusions to achieve this level are allowed).

Subjects must have adequate hepatic function as evidenced by: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered due to leukemic disease and serum total bilirubin ≤1.5 x upper limit of normal (ULN), unless considered due to Gilbert's disease or leukemic disease

Subjects must have adequate renal function as evidenced by a serum creatinine ≤2.0 × ULN or creatinine clearance \>40mL/min based on Cockroft-Gault glomerular filtration rate (GFR)

Subjects must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.

Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy and on the first day of study drug administration. Key

Exclusion Criteria

Subjects who have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of AG-120, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). (The use of a stable dose of oral steroids post HSCT and/or topical for ongoing skin GVHD is permitted.)

Subjects who received systemic anticancer therapy or radiotherapy \<14 days prior to their first day of study drug administration. (Hydroxyurea is allowed prior to enrollment and after the start of AG-120).

Subjects who received an investigational agent \<14 days prior to their first day of study drug administration.

Subjects who are pregnant or breastfeeding.

Subjects with an active severe infection or with an unexplained fever \>38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, subjects with tumor fever may be enrolled).

Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \<40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within approximately 28 days of C1D1.

Subjects with a history of myocardial infarction within the last 6 months of screening.

Subjects with a known unstable or uncontrolled angina pectoris.

Subjects with a known history of severe and/or uncontrolled ventricular arrhythmias.

Subjects with known unstable or uncontrolled angina pectoris.

Subjects with heart-rate corrected QT (QTc) interval ≥450 ms or other factors that increase the risk of QT prolongation or arrhythmic events.

Patients taking medications that are known to prolong the QT interval

Subjects with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C.

Subjects with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if there is a clinical suspicion of CNS involvement by leukemia during screening.

Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.

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 Los Angeles?

Yes, this clinical trial (NCT02074839) has an active research site in Los Angeles, CA 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.

Relapsed or Refractory Acute Myeloid Leukemia (AML) Treatment Options in Los Angeles, CA

If you're searching for relapsed or refractory acute myeloid leukemia (aml) treatment options in Los Angeles, CA, this clinical trial (NCT02074839) 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 Los Angeles research site is actively enrolling participants for this clinical trial. You'll receive care from experienced relapsed or refractory acute myeloid leukemia (aml) 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 relapsed or refractory acute myeloid leukemia (aml) clinical trials near you to find additional studies recruiting in your area.

Relapsed or Refractory Acute Myeloid Leukemia (AML) Clinical Trial in Los Angeles, CA

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