Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00866749|
Recruitment Status : Completed
First Posted : March 20, 2009
Last Update Posted : August 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoblastic Leukemia Lymphoblastic Lymphoma||Drug: Daunorubicin Drug: Vincristine Drug: PEG-asparaginase Drug: Intrathecal Methotrexate Drug: Cyclophosphamide Drug: Cytarabine Drug: Mercaptopurine Drug: Methotrexate Drug: Doxorubicin Drug: Thioguanine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Augmented Berlin-Frankfurt-Munster Therapy for Adolescents/Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma|
|Actual Study Start Date :||September 12, 2006|
|Actual Primary Completion Date :||July 26, 2018|
|Actual Study Completion Date :||July 26, 2018|
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®
Starting Dose 2 mg by vein weekly
Other Name: Vincasar®
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®
Starting Dose 1g/m2 by vein in weeks 1 and 5
Other Name: Cytoxan®
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®
Starting Dose 60 mg/m2 by mouth on days 1-14 of each month
Other Name: Purinethol®
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®
25 mg/m2 by vein in weeks 1, 2 and 3
Other Name: Adriamycin®
60 mg/m2 by mouth daily for two weeks
Other Name: Thioguanine Tabloid®
- 3-Year Event-Free Survival (EFS) Rate [ Time Frame: 3 Years ]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 ]Patient Response categorized as Response With Toxicity, Response Without Toxicity, No Response With Toxicity, No Response No Toxicity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|