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NCT02484430CompletedPhase 2

Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia

A Phase 2 Study of MLN0128 (TAK-228) in Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL)

Source: ClinicalTrials.gov · Last updated 3 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
16 (actual)
First submitted
26 Jun 2015
Start date
6 Apr 2017
Primary completion date
28 Dec 2018
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT02484430

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 16
  • From 6 Apr 2017 to the primary completion date, 28 Dec 2018
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have had chemotherapy or radiotherapy =\< 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; treatment with glucocorticoids, hydroxyurea, and tyrosine kinase inhibitors is allowed up to 24 hour prior to initiation of therapy
  • Patients who are receiving any other investigational agents
  • There are no prohibitions of specific medications on the basis of anticipated drug-drug interactions
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; no ischemic myocardial or cerebrovascular event, placement of pacemaker, or pulmonary embolism within six months of receiving first dose of MLN0128 (TAK-228)
  • Any patient receiving chronic corticosteroid administration prior to study enrollment is ineligible
  • Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs

Other illness

  • Patients with known other active cancers; skin cancers (basal or squamous) are exempted
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN0128 (TAK-228)

Lab values

  • Patients with white blood cell (WBC) \> 30,000 are not eligible to start therapy; however, it is permissible to use glucocorticoids and/or hydroxyurea to diminish peripheral WBC to less than 30,000 provided these agents are stopped at least 24 hours prior to the first dose of MLN0128 (TAK-228)
  • Baseline prolongation of the rate-corrected QT interval (QTc) \> 480 milliseconds or history of congenital long QT syndrome or Torsades de pointes

Who the study is looking for

  • World Health Organization (WHO)-defined acute lymphoblastic leukemia and either:
    • Relapsed after achieving remission
    • Refractory to therapy
    • Newly diagnosed and ineligible for intensive chemotherapy induction Note: patients with T lineage and B lineage ALL are eligible for this trial; likewise, patients with Philadelphia chromosome positive (Ph+) (as long as they are not candidate for other therapies for Ph+) and Ph- ALL are eligible
  • Bone marrow blasts of at least 10%
  • At least 4 weeks away from any previous antineoplastic or investigational agent; patients may receive hydroxyurea or glucocorticoids for suppression of leukocytosis, but these must be stopped at least 24 hours (h) prior to initiation of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  • Life expectancy of \> 2 months
  • Total bilirubin =\< 1.5 x institutional upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
  • Creatinine =\< 1.5 x institutional upper limit of normal
  • Fasting blood glucose (FBG) \< 130 mg/dL
  • Hemoglobin A1C (HbA1C) \< 7.0%
  • Relapse after SCT is allowed but no active graft-versus-host disease (GVHD) as per treating physician; also must not exceed the number of prior induction regimens listed above; SCT does not count as line of therapy
  • Negative serum pregnancy test result; Note: women of child-bearing potential and men must agree to use 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling \[e.g. United States product insert (USPI), Summary of Product Characteristics (SmPC), etc\]) after the last does of study drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use highly effective barrier contraception prior to the study, for the duration of study participation, and 4 months after completion of MLN0128 (TAK-228) administration
  • Ability to understand and the willingness to sign a written informed consent document
  • No prior therapy with mTOR inhibitors except for rapalog treatment as part of graft-versus-host (GVH) prophylaxis or treatment
  • Human immunodeficiency virus (HIV) infected patients (if HIV positive)
    • HIV infected individuals are eligible provided they meet all the protocol eligibility criteria in addition to the following:
    • No history of acquired immune deficiency syndrome (AIDS) defining illness other than a historic CD4+ T-cell nadir \< 200/mm\^3
    • Prior to leukemia diagnosis, the HIV disease was uncomplicated as evidenced by:
    • The CD4+ T-cell counts were generally in excess of 300/mm\^3
    • The HIV viral loads were less than 200 copies/ml if on anti-HIV therapy
    • If the HIV is newly diagnosed or there is no history of using anti-HIV therapy, there are no AIDS defining conditions or other HIV-related symptoms
    • Zidovudine is not allowed as part of the anti-HIV therapy
  • Patients with diabetes controlled by diet or medication are allowed on trial; controlled diabetes is defined as FBG \< 130 mg/kL in the context of this study

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins University/Sidney Kimmel Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
University of Kansas Clinical Research Center
Coordinator of this site? Confirm its status
FairwayUnited StatesUnknown status
Mayo Clinic in Florida
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
University of Kansas Cancer Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Los Angeles General Medical Center
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Los AngelesUnited StatesUnknown status
Mayo Clinic Hospital in Arizona
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PhoenixUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
Huntsman Cancer Institute/University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
Mayo Clinic in Arizona
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ScottsdaleUnited StatesUnknown status
Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
MedStar Georgetown University Hospital
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.