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Rapamycin in Relapsed Acute Lymphoblastic Leukemia

365 Days
Open (Enrolling)
Acute Lymphoblastic Leukemia

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Trial Information

Rapamycin in Relapsed Acute Lymphoblastic Leukemia

- 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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Compare changes in gene expression signatures in steroid alone versus steroid plus rapamycin treated patients.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Lewis Silverman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

October 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • rapamycin
  • corticosteroid
  • ALL
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Dana-Farber Cancer Institute Boston, Massachusetts  02115