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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00866749
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Lymphoblastic Leukemia Lymphoblastic Lymphoma Drug: Daunorubicin Drug: Vincristine Drug: PEG-asparaginase Drug: Intrathecal Methotrexate Drug: Cyclophosphamide Drug: Cytarabine Drug: Mercaptopurine Drug: Methotrexate Drug: Doxorubicin Drug: Thioguanine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Augmented Berlin-Frankfurt-Munster Therapy for Adolescents/Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Actual Study Start Date : September 12, 2006
Actual Primary Completion Date : July 26, 2018
Actual Study Completion Date : July 26, 2018

Arm Intervention/treatment
Experimental: Augmented BFM Therapy
Induction + Maintenance: Daunorubicin, Vincristine, PEG-asparaginase, Intrathecal Methotrexate, Cyclophosphamide, Cytarabine, Mercaptopurine, Doxorubicin, Thioguanine
Drug: Daunorubicin
Starting Dose 25 mg/m^2 by vein weekly
Other Name: Cerubidine®

Drug: Vincristine
Starting Dose 2 mg by vein weekly
Other Name: Vincasar®

Drug: PEG-asparaginase
Starting Dose 2000 International units/m2 by vein in week 1
Other Name: Oncaspar®

Drug: Intrathecal Methotrexate
Starting Dose 12 mg on week 2 and week 5 injected into spinal fluid
Other Name: Rheumatrex®

Drug: Cyclophosphamide
Starting Dose 1g/m2 by vein in weeks 1 and 5
Other Name: 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 Name: Cytosar-U®

Drug: Mercaptopurine
Starting Dose 60 mg/m2 by mouth on days 1-14 of each month
Other Name: 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 Name: Rheumatrex®

Drug: Doxorubicin
25 mg/m2 by vein in weeks 1, 2 and 3
Other Name: Adriamycin®

Drug: Thioguanine
60 mg/m2 by mouth daily for two weeks
Other Name: Thioguanine Tabloid®

Primary Outcome Measures :
  1. 3-Year Event-Free Survival (EFS) [ Time Frame: 3 Years ]
    3-year EFS was calculated based on the participants with a complete response (CR). Study regimen considered successful if it exhibits a 3-year EFS rate greater than 60% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.

  2. Overall Survival [ Time Frame: Up to 12 years ]
    Overall Survival defined: Time from date of treatment start until date of death due to any cause or last Follow-up.

  3. Participants With a Complete Response (CR) [ Time Frame: Up to 1 year ]
    Complete Response defined as: Bone Marrow blasts </= 5%, Platelets >/= 100 and an Absolute Neutrophil Count (ANC) >/= 1000

Secondary Outcome Measures :
  1. Participants Achieving Negative Minimal Residual Disease (MRD) [ Time Frame: up to 3 months ]
    To evaluate the prognostic significance of minimal residual disease (MRD) in bone marrow samples of participants who achieved a complete response (CR) at the end of induction (day 29) and at the end of consolidation (day 84) in this group of patients.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00866749

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Michael E. Rytting, M.D. M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00866749    
Other Study ID Numbers: 2006-0375
NCI-2012-01650 ( Registry Identifier: NCI CTRP )
First Posted: March 20, 2009    Key Record Dates
Results First Posted: September 10, 2019
Last Update Posted: September 10, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
acute lymphoblastic leukemia
acute lymphoblastic lymphoma
Intrathecal Methotrexate
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists