Augmented Berlin-Frankfurt-Munster (BFM) Therapy for Adolescent/Young Adults With Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma

Completed · Phase 2

Conditions studied: Lymphoblastic Leukemia, Lymphoblastic Lymphoma

In brief

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 lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL). B. Secondary objective: 1. 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. 2. To prospectively evaluate gene hypermethylation status in this group of patients. 3. To prospectively analyze asparaginase activity and anti-asparaginase antibody formation in this population of patients.

Key facts

Study ID

NCT00866749

Run by

M.D. Anderson Cancer Center

People needed

120

Starts

2006-09-12

Expected to finish

2018-07-26

Last updated by the study team

2019-09-10

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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