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Study Summary
No. 2006-0375:.......Leukemia; Lymphoma......Michael E. Rytting......Leukemia
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Study Summary Title
Study Summary
Number:
2006-0375
Study Title:Augmented Berlin-Frankfurt-Munster therapy for adolescents/young adults with acute lymphoblastic leukemia or lymphoblastic lymphoma
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Physician New Patient Referral
Name:Michael E. RyttingPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-4855
Contact us about clinical trials
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General Information
Disease Group:Leukemia
Lymphoma
Supported By:N/A
Phase of Study:Phase IIReturn
Visit:
weekly until maintenance therapy begins then monthly
Treatment
Agents:
6-MP
6-Thioguanine
Cyclophosphamide
Cytarabine
Daunorubicin
Dexamethasone
Doxorubicin
Methotrexate
PEG-L-Asparaginase
Prednisone
Vincristine
Home Care:Home care as directed by the primary physician upon discussion with study
principal investigator
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
5 to 7days at the start of induction.
Description/
Intervention:
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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Study Objectives / Outcomes
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
    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.
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    Study Status Information
    Study Activation / Registration Date:09/12/2006
    IRB Review and Approval Date:08/02/2006
    Study Type:Phase Ii Or Phase I/Ii
    Recruitment Status:Open
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

    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)

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    Links
    Registration Number: NCT00866749
    Study Information on Clinical Trials Registry (clinicaltrials.gov)

    Other Links:
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    Results


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