Rapamycin in Relapsed Acute Lymphoblastic Leukemia

Completed · Phase 1

Conditions studied: Acute Lymphoblastic Leukemia

In brief

This is a research study designed to look at the biological effects of two drugs on leukemia cells. In this study, we are comparing the effects of drugs called corticosteroids when used alone or with another drug called rapamycin. Rapamycin is a drug that prevents the body's immune system from working normally. It has been used for many years after kidney transplants to prevent rejection of the organ. Recent work suggests that rapamycin may also help treat leukemia and other cancers.

Key facts

Study ID

NCT00874562

Run by

Dana-Farber Cancer Institute

People needed

6

Starts

2007-07-01

Expected to finish

2016-04-01

Last updated by the study team

2016-11-23

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented acute lymphoblastic leukemia (L1 or L2 subtypes)
• First or subsequent relapse
• 365 days of age or older
• Greater than 7 days from any chemotherapy or immunotherapy, with the exception of intrathecal chemotherapy
• Absolute peripheral leukemia blast count of 1000 cells/ul or greater
• Patient (or parent/guardian if patient is less than 18 years of age) must sign informed consent

You may not qualify if…

• Burkitts leukemia (acute lymphoblastic leukemia L3 subtype)
• Uncontrolled active infection
• Pregnancy or mothers who are nursing
• Patient currently taking rapamycin
• Patients with significant liver dysfunction as outlined in protocol
• Severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into the study
• Active psychiatric disease, substance abuse, or mental illness that would interfere with cooperation with the requirements of the trial

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.