A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)
Investigating Chemotherapy with or without investigational medication for T-Cell Leukemia and Lymphoma
Brief description of study.
This randomized phase III clinical trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma.
Detailed description of study
This randomized phase III clinical trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: lymphoma,leukemia,T- Lymphoblastic Leukemia (T-ALL) ,T- Lymphoblastic Lymphoma (T-LLy),T- Lymphoblastic Leukemia ,T-ALL,T- Lymphoblastic Lymphoma,T-LLy,lymphoblastic,cancer,oncology,pediatric,kid,kids,child,children,adolescent,youth,teen,teens,teenager,teenagers,riley
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Age: 2 years - 30 years
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Gender: All
Inclusion Criteria
Patients must be enrolled on Project: Every Child (APEC14B1) prior to treatment and enrollment on AALL1231
Patients must have newly diagnosed T-lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma (T-LLy) stages II-IV
Exclusion Criteria
Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of protocol therapy on AALL1231
Uncontrolled seizure disorder
Diagnosis of Down syndrome (Trisomy 21)
Patients who are pregnant
Lactating females who plan to breastfeed
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
Patient has hypersensitivity to bortezomib, boron, or mannitol
Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and within 30 days of any dose of bortezomib
This study investigates the effectiveness of combination chemotherapy with or without an investigational medication in patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or stage II-IV T-cell lymphoblastic lymphoma (T-LLy). T-cell acute lymphoblastic leukemia is a type of cancer that affects the blood and bone marrow, while T-cell lymphoblastic lymphoma is a similar type of cancer that affects the lymph nodes.
Participants in the study will receive either chemotherapy alone or chemotherapy combined with an investigational medication. Chemotherapy is a treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
- Who can participate: Eligible individuals must be newly diagnosed with T-ALL or T-LLy stages II-IV, enrolled in Project: Every Child, and meet age criteria. Exclusions include prior cytotoxic chemotherapy, uncontrolled seizure disorder, and Down syndrome.
- Study details: Participants will be randomly assigned to receive either chemotherapy alone or with an investigational medication. No placebo will be used in this study.
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