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Rapamycin in Relapsed Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00874562
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : November 23, 2016
Information provided by (Responsible Party):

April 1, 2009
April 2, 2009
November 23, 2016
July 2007
November 2009   (Final data collection date for primary outcome measure)
  • Compare changes in gene expression signatures in steroid alone versus steroid plus rapamycin treated patients. [ Time Frame: 3 years ]
  • Compare biologic measures of "pro-apoptotic state" in steroid alone versus steroid plus rapamycin treated patients [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT00874562 on ClinicalTrials.gov Archive Site
Assess clinical response by percent reduction of peripheral leukemia blasts at day 2 of therapy and at completion of the 5-day investigational window [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
Rapamycin in Relapsed Acute Lymphoblastic Leukemia
Rapamycin in Relapsed Acute Lymphoblastic Leukemia
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.
  • 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, during which time we will collect blood samples to measure the biologic effects of these drugs. Because these drugs will be given for a short period of time only, this study is not designed to treat or cure the participants leukemia. After the 5-day period, participants may resume other cancer-directed therapies.
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Acute Lymphoblastic Leukemia
  • Drug: Corticosteroid
    Initial dose of corticosteroid given intravenously. After the first dose, corticosteroid will be taken orally every 8 hours for the duration of the five-day period
  • Drug: Rapamycin
    Taken orally mixed with water or orange juice
    Other Name: sirolimus
  • Active Comparator: Steroid Only
    Corticosteroid Alone
    Intervention: Drug: Corticosteroid
  • Active Comparator: Steroid plus Rapamycin
    Corticosteroid plus Rapamycin
    • Drug: Corticosteroid
    • Drug: Rapamycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2016
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sexes Eligible for Study: All
365 Days and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: No
Lewis B. Silverman, M.D., Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Boston Children’s Hospital
  • National Cancer Institute (NCI)
Principal Investigator: Lewis Silverman, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP