Clinical Trials Directory

A Phase II Study of Single-Agent MLN9708 for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML) With Mutated Nucleophosmin-1 (NPM1+)

This phase II trial studies how well ixazomib works in treating patients with relapsed or refractory acute myeloid leukemia. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : ixazomib
  • other : laboratory biomarker analysis

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Diagnosis of relapsed or refractory AML of any French American British (FAB) subtype except M3 and NPM1 genetic mutation detected by molecular assay; AML patients treated at Stanford have NPM1 molecular mutation status checked routinely at time of diagnosis in a Clinical Laboratory Improvement Amendment (CLIA)-certified laboratory - Male or female patients and no race-ethnic restrictions - Patients are unwilling, or who are determined to be medically unfit for or resistant to standard intensive induction chemotherapy; patients who are medically unfit will be determined by the treating primary hematologist and the principal investigator (including but not limited to evaluation of co-morbidities, and response and complications to previous AML treatment strategy) - Eastern Cooperative Oncology Group (ECOG) 0-2 - Ability to understand and the willingness to sign a written informed consent document - Female patients who: - Are postmenopausal for at least 1 year before the screening visit, OR - Are surgically sterile, OR - If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND - Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR - Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) - Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: - Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR - Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR - Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) - Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN - Calculated creatinine clearance >= 30 mL/min

External Links

Explore related trials

Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061
Not Recruiting

Footer Links: