Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
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:
- 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.
- To prospectively evaluate gene hypermethylation status in this group of patients.
- To prospectively analyze asparaginase activity and anti-asparaginase antibody formation in this population of patients.
Drug: Intrathecal Methotrexate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Augmented Berlin-Frankfurt-Munster Therapy for Adolescents/Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma|
- 3-Year Event-Free Survival (EFS) Rate [ Time Frame: 3 Years ] [ Designated as safety issue: No ]Study regimen considered successful if it exhibits a 3-year EFS rate greater than 60% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.
- Efficacy Monitoring by Patient Response [ Time Frame: 3 Years ] [ Designated as safety issue: No ]Patient Response categorized as Response With Toxicity, Response Without Toxicity, No Response With Toxicity, No Response No Toxicity.
|Study Start Date:||September 2006|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: Augmented BFM Therapy
Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine
Starting Dose 25 mg/m^2 by vein weekly
Other Name: Cerubidine®Drug: Vincristine
Starting Dose 2 mg by vein weekly
Other Name: Vincasar®Drug: PEG-asparaginase
Starting Dose 2000 International units/m2 by vein in week 1
Other Name: Oncaspar®Drug: Intrathecal Methotrexate
Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid
Other Name: Rheumatrex®Drug: Cyclophosphamide
Starting Dose 1g/m2 by vein in weeks 1 and 5
Other Name: Cytoxan®Drug: Cytarabine
75 mg/m2 subcutaneous or by vein for four consecutive days on days 1-4 and days 8-11 of both months
Other Name: Cytosar-U®Drug: Mercaptopurine
Starting Dose 60 mg/m2 by mouth on days 1-14 of each month
Other Name: Purinethol®Drug: Methotrexate
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
Other Name: Rheumatrex®Drug: Doxorubicin
25 mg/m2 by vein in weeks 1, 2 and 3
Other Name: Adriamycin®Drug: Thioguanine
60 mg/m2 by mouth daily for two weeks
Other Name: Thioguanine Tabloid®
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866749
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael E. Rytting, M.D.||M.D. Anderson Cancer Center|