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mTOR Inhibitor

Sapanisertib for Acute Lymphoblastic Leukemia

Q: What is the peak capacity for individuals participating in this experiment?

The trial is no longer looking for participants; it was first posted on October 20th 2016 and most recently updated on May 4th 2022. For those in search of an alternative research program, there are 1496 clinical trials actively enrolling patients with refractory adult <a href="https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia">acute lymphoblastic leukemia</a> as well as 11 Pharmacological Studies recruiting individuals.

Q: Are there opportunities to participate in this experiment at the moment?

According to clinicaltrials.gov, the recruitment phase of this trial has concluded--the posting was first published on October 20th 2016 and last updated May 4th 2022. However, there are presently 1,507 other studies actively recruiting patients.

Q: What potential danger do participants of Pharmacological Study face?

There is evidence indicating that Pharmacological Study may be safe, so it was assigned a score of 2. No studies have been conducted to evaluate its efficacy yet.

Q: What is the geographic extent of this clinical trial's implementation?

Currently, 14 medical sites are recruiting for this trial. Such locations include the Mayo Clinic in <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> (Jacksonville), Johns Hopkins University/Sidney Kimmel <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Baltimore and Huntsman Cancer Institute/University of <a href="https://www.withpower.com/clinical-trials/utah">Utah</a> in Salt Lake City; to name a few out of the full roster of available clinical centres.

Q: Are there any precedential experiments involving Pharmacological Study?

The Pharmacological Study was inaugurated in 2014 by Dana-Farber <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Institute. Currently, there are 11 functional studies and 611 concluded ones; many of these trials occur in Jacksonville, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>.

Q: What objectives has this experiment been designed to fulfill?

This clinical trial, lasting 61 days, will principally assess the complete response rate (CR/CRI) among participants. Secondary outcomes monitored include Adverse Event frequency per NCI CTCAE v4 guidelines and duration of CR/CRI; further, Allogeneic Stem Cell Transplantation (SCT) post-response rates will also be tallied and exact binomial 95% confidence intervals for overall response rate calculated.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 23 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I can take care of myself and perform daily activities.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete Response (CR or CRi)

Secondary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,651 Total Patients Enrolled

Aref Al-KaliPrincipal InvestigatorMayo Clinic Cancer Center LAO

3 Previous Clinical Trials

98 Total Patients Enrolled

Media Library

Sapanisertib (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02484430 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the peak capacity for individuals participating in this experiment?

"The trial is no longer looking for participants; it was first posted on October 20th 2016 and most recently updated on May 4th 2022. For those in search of an alternative research program, there are 1496 clinical trials actively enrolling patients with refractory adult acute lymphoblastic leukemia as well as 11 Pharmacological Studies recruiting individuals."

Answered by AI

Are there opportunities to participate in this experiment at the moment?

"According to clinicaltrials.gov, the recruitment phase of this trial has concluded--the posting was first published on October 20th 2016 and last updated May 4th 2022. However, there are presently 1,507 other studies actively recruiting patients."

Answered by AI

What potential danger do participants of Pharmacological Study face?

"There is evidence indicating that Pharmacological Study may be safe, so it was assigned a score of 2. No studies have been conducted to evaluate its efficacy yet."

Answered by AI

What is the geographic extent of this clinical trial's implementation?

"Currently, 14 medical sites are recruiting for this trial. Such locations include the Mayo Clinic in Florida (Jacksonville), Johns Hopkins University/Sidney Kimmel Cancer Center in Baltimore and Huntsman Cancer Institute/University of Utah in Salt Lake City; to name a few out of the full roster of available clinical centres."

Answered by AI

Are there any precedential experiments involving Pharmacological Study?

"The Pharmacological Study was inaugurated in 2014 by Dana-Farber Cancer Institute. Currently, there are 11 functional studies and 611 concluded ones; many of these trials occur in Jacksonville, Florida."

Answered by AI

What objectives has this experiment been designed to fulfill?

"This clinical trial, lasting 61 days, will principally assess the complete response rate (CR/CRI) among participants. Secondary outcomes monitored include Adverse Event frequency per NCI CTCAE v4 guidelines and duration of CR/CRI; further, Allogeneic Stem Cell Transplantation (SCT) post-response rates will also be tallied and exact binomial 95% confidence intervals for overall response rate calculated."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02484430.

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