Status:
COMPLETED
Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Eligibility:
All Genders
12-40 years
Phase:
PHASE2
Brief Summary
Objectives: 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 lymp...
Detailed Description
Induction: During Induction, you will receive augmented Berlin-Frankfurt-Munster chemotherapy, which is made up of a combination of Cerubidine®, Daunorubicin Hydrochloride (daunorubicin), Oncovin® (v...
Eligibility Criteria
Inclusion
- 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 Central Nervous System (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
- 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)
Key Trial Info
Start Date :
September 12 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00866749
Start Date
September 12 2006
End Date
July 26 2018
Last Update
September 10 2019
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030