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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00866749
First received: March 19, 2009
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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

  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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Augmented Berlin-Frankfurt-Munster Therapy for Adolescents/Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 3-Year Event-Free Survival (EFS) Rate [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
    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%.


Secondary Outcome Measures:
  • Efficacy Monitoring by Patient Response [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
    Patient Response categorized as Response With Toxicity, Response Without Toxicity, No Response With Toxicity, No Response No Toxicity.


Estimated Enrollment: 125
Study Start Date: September 2006
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866749

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michael E. Rytting, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00866749     History of Changes
Other Study ID Numbers: 2006-0375, NCI-2012-01650
Study First Received: March 19, 2009
Last Updated: November 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
acute lymphoblastic leukemia
acute lymphoblastic lymphoma
Leukemia
ALL
6-Thioguanine
Cyclophosphamide
Cytarabine
Daunorubicin
Doxorubicin
Methotrexate
PEG-L-Asparaginase
Vincristine
Intrathecal Methotrexate
Mercaptopurine

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
6-Mercaptopurine
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Doxorubicin
Liposomal doxorubicin
Methotrexate
Pegaspargase
Thioguanine
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents

ClinicalTrials.gov processed this record on November 24, 2014