Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
This study is currently recruiting participants.
Verified February 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00866749
First received: March 19, 2009
Last updated: February 14, 2013
Last verified: February 2013
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Purpose
The goal of this clinical research study is to learn if augmented Berlin-Frankfurt-Munster (BFM) will be an effective treatment for patients with ALL or LL.
| Condition | Intervention | 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 |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Mercaptopurine
Methotrexate
Cytarabine
Thioguanine
Vincristine sulfate
Asparaginase
Methotrexate sodium
Daunorubicin
Doxorubicin
Daunorubicin hydrochloride
Doxorubicin hydrochloride
Pegaspargase
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- 3-Year Event-Free Survival (EFS) rate [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 125 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Augmented BFM Therapy
Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine
|
Drug: Daunorubicin
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 100mg/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
Eligibility| Ages Eligible for Study: | 12 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have precursor-B or T-lymphoblastic leukemia or lymphoblastic lymphoma.
- Patients must be untreated or have had only one prior chemotherapy regimen for ALL or LL . Previously treated patients will be analyzed separately.
- Age between 12 to 40 years old
- Patients with CNS disease or testicular disease are eligible.
- Intrathecal therapy with cytarabine is allowed prior to registration for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. Systemic chemotherapy must begin within 72 hours of the first intrathecal treatment.
- Signed informed consent prior to the start of systemic therapy. In the event of enrollment of a minor patient, an attempt to obtain assent from the patient must be documented, and parental consent must be signed.
- Echocardiogram should be done within 72 hours of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction)
- Creatinine should be < 3 mg/dL bilirubin < 3 mg/dl unless felt to be due to disease
- Zubrod Performance status of <3
- Patients who received steroids more than 72 hours prior to study enrollment are eligible but will be analyzed separately
Exclusion Criteria:
- Age less than twelve years of age or greater than 40 years.
- More than one prior treatment regimen for ALL or LL.
- The patient is pregnant or unwilling to practice appropriate birth control.
- Presence of the Philadelphia chromosome t(9;22)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866749
Contacts
| Contact: Michael E. Rytting, M.D. | 713/792-4855 | mrytting@mdanderson.org |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Michael E. Rytting, M.D. 713-792-4855 mrytting@mdanderson.org | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Michael E. Rytting, M.D. | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00866749 History of Changes |
| Other Study ID Numbers: | 2006-0375 |
| Study First Received: | March 19, 2009 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
acute lymphoblastic leukemia acute lymphoblastic lymphoma Leukemia ALL 6-Thioguanine Cyclophosphamide Cytarabine |
Daunorubicin Doxorubicin Methotrexate PEG-L-Asparaginase Vincristine Intrathecal Methotrexate Mercaptopurine |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Thioguanine |
Cyclophosphamide Pegaspargase Asparaginase Daunorubicin Doxorubicin Vincristine Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013