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Brief Title: Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia
Official Title: A Phase 2 Study of MLN0128 (TAK-228) in Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL)
Study ID: NCT02484430
Brief Summary: This phase II trial studies how well sapanisertib works in treating patients with acute lymphoblastic leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Sapanisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the complete hematologic response (CR)/complete response incomplete (CRi) rate when sapanisertib (MLN0128 \[TAK-228\]) is administered to adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL). SECONDARY OBJECTIVES: I. To determine the overall response rate (CR, CRi/partial response (PR)/morphologic leukemia free state \[MLFS\]). II. To determine the CR/CRi duration when MLN0128 (TAK-228) is administered to adult patients with relapsed/refractory ALL. III. To determine the frequency of proceeding to allogeneic stem cell transplantation (SCT) for patients with relapsed/refractory ALL who achieve a response on MLN0128 (TAK-228). IV. To determine the overall survival for relapsed/refractory ALL patients on MLN0128 (TAK-228). TERTIARY OBJECTIVES: I. To examine the pharmacokinetics of MLN0128 (TAK-228) in ALL patients. II. To assess whether phosphorylation of the mTOR substrate 4EBP1 decreases in leukemic blasts harvested from the bone marrow on day 8 compared to baseline. III. To assess in an exploratory fashion whether MLN0128 (TAK-228) enhances expression of the pro-apoptotic proteins Bim and Puma in marrow ALL cells. IV. To assess in an exploratory fashion whether Mcl-1 levels decrease in blast cells during MLN0128 (TAK-228) treatment. V. To assess in an exploratory fashion whether a) the phospho-protein pattern at baseline or b) MLN0128 (TAK-228)-associated changes in the phospho-protein pattern differs between ALL samples that respond to therapy and those that do not. OUTLINE: Patients receive sapanisertib orally (PO) daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are non-responders and in PR at the end of course 4 may receive sapanisertib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Name: Aref Al-Kali
Affiliation: Mayo Clinic Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR