Phase 2
N=16
Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia · B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 · B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative · Recurrent Adult Acute Lymphoblastic Leukemia · Refractory Adult Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02484430 ↗Enrolled (actual)
16
Serious AEs
56.3%
Results posted
May 2022
Primary outcome: Primary: Complete Response (CR or CRi) — 0 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Pharmacological Study (Other); Sapanisertib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR or CRi) |
— | — |
| SECONDARY Overall Response |
— | — |
| SECONDARY Duration of Complete Response |
— | — |
| SECONDARY Frequency of Proceeding to Allogeneic Stem Cell Transplantation (SCT) After Achieving Response (Complete Hematologic Response [CR]/Complete Response Incomplete [CRi] Partial Response [PR], or Morphologic Leukemia Free State [MLFS]) to Sapanisertib |
— | — |
| SECONDARY Overall Survival |
62.0 | — |
| SECONDARY Incidence of Adverse Events, Measured Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 |
0; 13; 2 | — |
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.
Eligibility Criteria
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 months
- Total bilirubin = 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)
- Patients who are receiving any other investigational agents
- 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)
- 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
- Baseline prolongation of the rate-corrected QT interval (QTc) > 480 milliseconds or history of congenital long QT syndrome or Torsades de pointes
- 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
Data sourced from ClinicalTrials.gov (NCT02484430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.