At a glance
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Augmented Berlin-Frankfurt-Munster Therapy for Adolescents/Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
In Brief
A Phase 2 clinical trial evaluating Daunorubicin, Vincristine, and 8 other interventions for Lymphoblastic Leukemia and Lymphoblastic Lymphoma. Completed, enrolled 120 participants across 1 site.
Detailed Summary
Objectives: A. Primary objective: 1 To assess the feasibility and the effectiveness of pediatric type therapy (augmented BFM) in patients age 12 through 40 with untreated precursor-B or T acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL). B. Secondary objective: 1. To evaluate the prognostic significance of minimal residual disease in bone marrow samples at the end of induction and at the end of consolidation in this group of patients. 2. To prospectively evaluate gene hypermethylation status in this group of patients. 3. To prospectively analyze asparaginase activity and anti-asparaginase antibody formation in this population of patients.
Study Details
Timeline
Interventions
Starting Dose 25 mg/m\^2 by vein weekly
Starting Dose 2 mg by vein weekly
Starting Dose 2000 International units/m2 by vein in week 1
Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid
Starting Dose 1g/m2 by vein in weeks 1 and 5
75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months
Starting Dose 60 mg/m2 by mouth on days 1-14 of each month
Starting Dose at 100 mg/m2 by vein and escalating by 50 mg/m2/dose every 10 +/- 2 days for 5 doses to toxicity (e.g myelosuppression or mucositis grade 3
25 mg/m2 by vein in weeks 1, 2 and 3
60 mg/m2 by mouth daily for two weeks