Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Lymphoblastic Leukemia Lymphoblastic Lymphoma |
| Intervention | Drug: Daunorubicin Drug: Vincristine Drug: PEG-asparaginase Drug: Intrathecal Methotrexate Drug: Cyclophosphamide Drug: Cytarabine Drug: Mercaptopurine Drug: Methotrexate Drug: Doxorubicin Drug: Thioguanine |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Responsible Party | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier | NCT00866749 |
| First Received | March 19, 2009 |
| Last Updated | April 23, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 19, 2009 |
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| Last Updated Date | April 23, 2014 |
| Start Date | September 2006 |
| Estimated Primary Completion Date | October 2016 |
| Current Primary Outcome Measures | 3-Year Event-Free Survival (EFS) rate [Time Frame: 3 Years] [Designated as safety issue: No] |
| Current 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. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma |
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| Official Title | Augmented Berlin-Frankfurt-Munster Therapy for Adolescents/Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma |
| Brief Summary | 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. |
| Detailed Description | During Induction, you will receive augmented Berlin-Frankfurt-Munster chemotherapy, which is made up of a combination of Cerubidine®, Daunorubicin Hydrochloride (daunorubicin), Oncovin® (vincristine), prednisone, dexamethasone, Oncaspar® (PEG Asparaginase), and MTX, amethopterin (methotrexate). All of these drugs are designed to interfere with the multiplication of cancer cells to cause them to die and to keep the cancer from coming back. If you are found to be eligible to take part in this study, on Day 1 or during the spinal tap procedure, you will be given cytarabine as an injection in your spinal fluid. Within 3 days, you will begin the Induction course, which will last for 4 weeks. Daunorubicin and vincristine will be given through a needle in your vein on Days 1, 8,15, and 22. During the first week of therapy, you will be given 1 infusion of PEG Asparaginase by vein. You will take prednisone by mouth on Days 1-28. Methotrexate will be injected into your spinal fluid on Weeks 2 and 5 during your spinal tap. Cerebrospinal fluid (CSF) studies will be sent with each spinal tap to test the fluid for leukemia. If there is disease in your spinal fluid before starting the treatment, you will be given additional methotrexate doses once a week until there is no disease present. You will continue to receive methotrexate in spinal taps every other week for 8 doses, then monthly for 6 doses. Blood (about 3 teaspoons) will be drawn multiple times during the study for routine tests. You will have a bone marrow aspirate or biopsy on Days 15 and 29 and then as needed to confirm remission. If you have less than 5% immature cells in the bone marrow, 1 week after Induction, you will continue treatment with Consolidation 1. If you achieved remission after 4 weeks of Induction treatment, you will then have treatment with Consolidation 1, which will be discussed in a separate informed consent document. If you have LL and had no bone marrow involvement at screening, you will have a chest x-ray, CT scans, and PET scans to measure the disease. Consolidation 1 and other phases of chemotherapy will be discussed in a separate informed consent document. If you still have more than 5% leukemia cells in the bone marrow after Induction therapy, you will receive 2 extra weeks of therapy called "Extended Induction" before going to the next phase of therapy. You will receive daunorubicin by vein on Day 1. You will receive vincristine on Weeks 1 and 2 by vein. You will take prednisone by mouth on Days 1-14. You will receive PEG Asparaginase by vein in the first week of the Extended Induction. Blood (about 3 teaspoons) will be drawn weekly during the Extended Induction period for routine tests. At the end of the Extended Induction period, you will have a physical exam and a bone marrow aspirate or biopsy to learn your response to treatment. After Extended Induction, if the disease is in remission, then you will have 1 course of Consolidation 1, 2 courses of Consolidation 2, and 2 courses of Consolidation 3 before proceeding to Maintenance therapy. A separate discussion and informed consent document for Consolidation and Maintenance will be provided. Length of Study: You may remain on study for as long as you are benefiting. However, if after Extended Induction, the disease is not in remission, you will be taken off study, and your doctor will discuss other treatment options with you. You may be taken off study if the disease gets worse or comes back during treatment, intolerable side effects occur, new information becomes available to your study doctor, if your doctor thinks it is in your best interest, or if you do not attend your appointments, which are scheduled at least once every 3 months. This is an investigational study. The chemotherapy drugs used in this study are FDA approved and commercially available. Up to 125 patients will take part in this study. All will be enrolled at MD Anderson. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Daunorubicin Starting Dose 25 mg/m^2 by vein weekly Other Names: Cerubidine®Drug: Vincristine Starting Dose 2 mg by vein weekly Other Names: Vincasar®Drug: PEG-asparaginase Starting Dose 2000 International units/m2 by vein in week 1 Other Names: Oncaspar®Drug: Intrathecal Methotrexate Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid Other Names: Rheumatrex®Drug: Cyclophosphamide Starting Dose 1g/m2 by vein in weeks 1 and 5 Other Names: 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 Names: Cytosar-U®Drug: Mercaptopurine Starting Dose 60 mg/m2 by mouth on days 1-14 of each month Other Names: 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 Names: Rheumatrex®Drug: Doxorubicin 25 mg/m2 by vein in weeks 1, 2 and 3 Other Names: Adriamycin®Drug: Thioguanine 60 mg/m2 by mouth daily for two weeks Other Names: Thioguanine Tabloid® |
| Study Arm (s) | Experimental: Augmented BFM Therapy Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
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| Estimated Enrollment | 125 |
| Estimated Completion Date | October 2016 |
| Estimated Primary Completion Date | October 2016 |
| Eligibility Criteria | Inclusion Criteria: 1. Patients must have precursor-B or T-lymphoblastic leukemia or lymphoblastic lymphoma. 2. Patients must be untreated or have had only one prior chemotherapy regimen for ALL or LL . Previously treated patients will be analyzed separately. 3. Age between 12 to 40 years old 4. Patients with CNS disease or testicular disease are eligible. 5. 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. 6. 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. 7. 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) 8. Creatinine should be < 3 mg/dL bilirubin < 3 mg/dl unless felt to be due to disease 9. Zubrod Performance status of <3 10. Patients who received steroids more than 72 hours prior to study enrollment are eligible but will be analyzed separately Exclusion Criteria: 1. Age less than twelve years of age or greater than 40 years. 2. More than one prior treatment regimen for ALL or LL. 3. The patient is pregnant or unwilling to practice appropriate birth control. 4. Presence of the Philadelphia chromosome t(9;22) |
| Gender | Both |
| Ages | 12 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00866749 |
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| Other Study ID Numbers | 2006-0375 |
| Has Data Monitoring Committee | No |
| Information Provided By | M.D. Anderson Cancer Center |
| Study Sponsor | M.D. Anderson Cancer Center |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Michael E. Rytting, M.D. M.D. Anderson Cancer Center |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| UT MD Anderson Cancer Center | Houston, Texas, United States, 77030 |
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