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mTOR Inhibitor

Sapanisertib for Acute Lymphoblastic Leukemia

Phase 2

Waitlist Available

Led By Aref Al-Kali

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with World Health Organization (WHO)-defined acute lymphoblastic leukemia who have relapsed after achieving remission, are refractory to therapy, or are newly diagnosed and ineligible for intensive chemotherapy induction

Patients with Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Must not have

Patients who had chemotherapy or radiotherapy =< 4 weeks prior to study entry or have not recovered from adverse events

Patients with concomitant administration of proton pump inhibitor (PPI) during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 23 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well sapanisertib works in treating relapsed or refractory acute lymphoblastic leukemia.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Sapanisertib may include risks related to enzyme inhibition which could affect cell growth in the body, possibly leading to fatigue, digestive issues, or abnormal blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia has come back, is not responding to treatment, or I can't undergo intense chemotherapy.

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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am taking proton pump inhibitors during the study.

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I have no active cancers except possibly for skin cancer.

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I have had allergic reactions to drugs similar to MLN0128.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 23 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~23 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 23 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response (CR or CRi)

Secondary study objectives

Duration of Complete Response

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

Incidence of Adverse Events, Measured Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (sapanisertib)Experimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sapanisertib

2016

Completed Phase 2

~840

0 / 6Eligibility criteria met