Protocol
11-119
Full Title
A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL POETIC and ITCC.
Purpose
Nelarabine is a drug that was approved in 2005 to treat T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic leukemia (T-LL). The purpose of this study is to assess the use of nelarabine when it is given in combination with two older drugs used to treat leukemia — etoposide and cyclophosphamide — in children with T-ALL or T-LL that has returned despite prior therapy.
Researchers will determine the optimal doses of these drugs that can be given safely in patients by observing side effects. This study is a collaboration between two research groups: POETIC (Pediatric Oncology Experimental Therapeutics Investigator Consortium) and TACL (Therapeutic Advances in Childhood Leukemia & Lymphoma).
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have T-ALL or T-LL that has relapsed or did not respond to induction therapy.
- At least 1 week must have passed since completing prior chemotherapy or intrathecal therapy and 12 weeks since radiation therapy to more than 25 percent of bone marrow-containing spaces.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- Patients must be between the ages of 1 and 21 (inclusive).
For more information about this study and to inquire about eligibility, please contact Dr. Tanya Trippett at 212-639-8267.
Disease(s)
Leukemia
Leukemia: Acute Lymphoblastic Leukemia
Locations
Related Diseases
