Status:
COMPLETED
Rapamycin in Relapsed Acute Lymphoblastic Leukemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Boston Children's Hospital
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
365+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
* Participants will be randomized into two groups; one group will receive corticosteroid alone, and the other group will receive rapamycin and corticosteroid. * The length of treatment will be 5 days,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00874562
Start Date
July 1 2007
End Date
April 1 2016
Last Update
November 23 2016
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215