drugset / Trial / NCT00866749
Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2006-09-12
- Primary completion
- 2018-07-26
- Completion
- 2018-07-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 1 unknown | Intravenous |
| Subject | Cytarabine | Small molecule | 75 mg/m2 | Subcutaneous |
| Subject | Daunorubicin | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 60 mg/m2 | Oral |
| Subject | Methotrexate | Small molecule | 12 mg | Intrathecal |
| Subject | Methotrexate | Small molecule | 100 mg/m2 | Intrathecal |
| Subject | Pegaspargase | Protein / enzyme biologic | 2000 unknown | Intravenous |
| Subject | Thioguanine | Small molecule | 60 mg/m2 | Oral |
| Subject | Vincristine | Small molecule | 2 mg | Intravenous |