Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (NCT02484430) | Clinical Trial Compass
CompletedPhase 2
Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia
United States16 participantsStarted 2017-04-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 seru…