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Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma


Title AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)
Therapeutic Area Leukemias (Pediatric), Lymphomas
Principal Investigator Michael Kelly, MD
Min Age 1 Years
Max Age 31 Years
Gender Both
Contact Jennifer Truong
617-636-8885
More Information http://clinicaltrials.gov/ct2/show/NCT02112916

Overview

The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.

Study Details

Inclusion Criteria

  • Newly diagnosed stage II or higher T-Lymphoblastic Leukemia (T-ALL) or T-Lymphoblastic Lymphoma

Exclusion Criteria

  • No prior anti-cancer therapy
  • No subjects with pre-existing nerve damage in hands and/or feet
  • No subjects with Down syndrome

Study Requirements

Subjects will receive standard treatment based on their risk assessment with or without the study drug bortezomib. Subjects will not have to come in for extra tests or hospital visits. All tests and hospital visits would be the same if subject was not in the study. If they agree to the optional studies, subjects will have 1 teaspoon (4-6 mL) of extra bone marrow taken for biological studies. Extra bone marrow will be drawn during a standard bone marrow biopsy for clinical care. Subjects will not require an extra bone marrow biopsy. Subjects will receive study intervention (standard treatment with or without the study drug) for 2 ½ to 3 years. After stopping study intervention, subjects will have follow up visits and tests. The study team would like to keep in touch with all subjects and learn about their health up to 10 years after they stop study intervention.
Nurse navigators for cancer patients at Tufts Medical Center.

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