A Phase I Study of BMS-906024 in Adult and Pediatric Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma

Protocol
11-181
Full Title
Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-906024 in Subjects with Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Phase
I
Disease Status
Relapsed/Refractory
Purpose

The purpose of this study is to find the highest dose of an investigational drug called BMS-906024 that can be given safely to adults, adolescents, and children with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma that has returned despite or has stopped responding to standard therapy. BMS-906024, which is given intravenously (by vein), inhibits a signaling pathway called Notch that helps cancer cells grow and survive. BMS-906024 also inhibits the development of blood vessels that cancers need to grow and spread.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma that has returned despite or has stopped responding to standard therapy.
  • At least 4 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 10 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Dan Douer (for patients age 18 and older) at 212-639-2471 or Dr. Neerav Shukla (for patients under age 18) at 212-639-5158.

Disease(s)
Leukemia
Leukemia: Acute Lymphoblastic Leukemia
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
Locations
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