Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
Launched by M.D. ANDERSON CANCER CENTER · Mar 19, 2009
Trial Information
Current as of June 07, 2025
Completed
Keywords
ClinConnect Summary
Induction:
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 in...
Gender
ALL
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 Central Nervous System (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)
About M.D. Anderson Cancer Center
The University of Texas MD Anderson Cancer Center is a leading institution dedicated to cancer care, research, education, and prevention. As one of the world’s most respected cancer centers, MD Anderson focuses on innovative treatment approaches and groundbreaking clinical trials aimed at improving patient outcomes. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to advancing cancer research and providing comprehensive, personalized care to patients. MD Anderson's clinical trials play a pivotal role in translating scientific discoveries into effective therapies, positioning the center at the forefront of cancer treatment and research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Patients applied
Trial Officials
Michael E. Rytting, M.D.
Principal Investigator
M.D. Anderson Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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