Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
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|ClinicalTrials.gov Identifier: NCT00866749|
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 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) [ Time Frame: 3 Years ]3-year EFS was calculated based on the participants with a complete response (CR). 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%.
- Overall Survival [ Time Frame: Up to 12 years ]Overall Survival defined: Time from date of treatment start until date of death due to any cause or last Follow-up.
- Participants With a Complete Response (CR) [ Time Frame: Up to 1 year ]Complete Response defined as: Bone Marrow blasts </= 5%, Platelets >/= 100 and an Absolute Neutrophil Count (ANC) >/= 1000
- Participants Achieving Negative Minimal Residual Disease (MRD) [ Time Frame: up to 3 months ]To evaluate the prognostic significance of minimal residual disease (MRD) in bone marrow samples of participants who achieved a complete response (CR) at the end of induction (day 29) and at the end of consolidation (day 84) in this group of patients.
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|