Trial for the Treatment of Newly Diagnosed Mature B-Cell Acute Lymphoblastic Leukemia (B-ALL), Burkitt's Non-Hodgkin's Lymphoma (NHL) and Other High-Grade Lymphoma in Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Information provided by:
Johann Wolfgang Goethe University Hospitals Identifier:
First received: September 12, 2005
Last updated: May 29, 2008
Last verified: May 2008
The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.

Condition Intervention Phase
Burkitt's Lymphoma
Burkitt's Leukemia
Mediastinal Neoplasms
Lymphoblastic Lymphoma
Large Cell Anaplastic Lymphoma
Drug: Adriamycin
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone/Prednisolone
Drug: VP16
Drug: Ifosfamide
Drug: Methotrexate
Drug: G-CSF
Drug: Rituximab
Drug: Vincristine/Vindesine
Procedure: Irradiation (in specific conditions)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)

Resource links provided by NLM:

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Remission rate
  • Remission duration
  • Disease free survival
  • Overall survival

Secondary Outcome Measures:
  • Dose and time compliance
  • Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)
  • Death under therapy and in complete remission (CR)
  • Localisations of relapse

Estimated Enrollment: 650
Study Start Date: July 2002
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma
  • Age > 15 years
  • Written informed consent

Exclusion Criteria:

  • Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected
  • HIV infection
  • Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy
  • Known severe allergy to foreign proteins
  • Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy.
  • Pregnancy or nursing
  • Participation in other studies that interfere with study therapy
  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 identifier: NCT00199082

Contact: Dieter Hoelzer, MD, PhD ++49(0)69 6301 5194
Contact: Nicola Goekbuget, MD ++49(0)69 6301 6365

University Hospital, Medical Dept. II Recruiting
Frankfurt, Germany, 60590
Contact: Dieter Hoelzer, MD, PhD    ++49(0)69 6301 5194   
Contact: Nicola Goekbuget, MD    ++49(0)69 6301 6365   
Principal Investigator: Dieter Hoelzer, MD, PhD         
Sub-Investigator: Nicola Goekbuget, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Study Chair: Dieter Hoelzer, MD University of Frankfurt, Medical Dept. II
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00199082     History of Changes
Other Study ID Numbers: GMALL05 
Study First Received: September 12, 2005
Last Updated: May 29, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
High-grade NHL
De novo
Mature B-ALL
Burkitt'S NHL
Primary mediastinal diffuse large cell lymphoma
B-precursor lymphoblastic lymphoma

Additional relevant MeSH terms:
Thoracic Diseases
Burkitt Lymphoma
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Mediastinal Neoplasms
DNA Virus Infections
Epstein-Barr Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoproliferative Disorders
Mediastinal Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Respiratory Tract Diseases
Thoracic Neoplasms
Tumor Virus Infections
Virus Diseases processed this record on May 25, 2016