Sapanisertib for Acute Lymphoblastic Leukemia

Recruiting at 14 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Proton pump inhibitors

Disqualifiers: Active cancers, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks per course

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Aref Al-Kali

Principal Investigator

Mayo Clinic Cancer Center LAO

Eligibility Criteria

This trial is for adults with acute lymphoblastic leukemia that's come back or hasn't responded to treatment. They should have controlled blood sugar, no severe active infections, and a life expectancy over 2 months. Pregnant women can't join, and participants must use effective contraception.

Inclusion Criteria

Patients with bone marrow blasts of at least 10%

Patients with ability to understand and sign a written informed consent document

Patients with a life expectancy of > 2 months

Exclusion Criteria

I haven't had chemotherapy or radiotherapy in the last 4 weeks or still have side effects.

I am taking proton pump inhibitors during the study.

Patients with baseline prolongation of the rate-corrected QT interval (QTc) > 480 milliseconds or history of congenital long QT syndrome or Torsades de pointes

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sapanisertib orally daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

4 weeks per course

Monthly visits for assessment

Extended Treatment

Non-responders and those in partial response at the end of course 4 may receive sapanisertib daily on days 1-28. Courses repeat every 28 days.

4 weeks per course

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

Every 3 months

Treatment Details

Interventions

• Sapanisertib

Trial Overview The trial tests Sapanisertib's effectiveness on relapsed/refractory acute lymphoblastic leukemia by blocking enzymes needed for cancer cell growth. It includes lab biomarker analysis and pharmacological studies to understand how the drug works.

Participant Groups

Group I: Treatment (sapanisertib) Experimental Treatment 3 Interventions

Patients receive sapanisertib 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+