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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

This study has been completed.
Information provided by (Responsible Party):
Nicola Goekbuget, Johann Wolfgang Goethe University Hospital Identifier:
First received: September 12, 2005
Last updated: August 4, 2016
Last verified: August 2016
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
Intervention Model: Parallel Assignment
Masking: None (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 Nicola Goekbuget, Johann Wolfgang Goethe University Hospital:

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
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00199082

University Hospital, Medical Dept. II
Frankfurt, Germany, 60590
Sponsors and Collaborators
Nicola Goekbuget
Principal Investigator: Nicola Goekbuget, Dr. med. University Hospital of Frankfurt (Main)
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nicola Goekbuget, Dr. med., Johann Wolfgang Goethe University Hospital Identifier: NCT00199082     History of Changes
Other Study ID Numbers: GMALL05
Study First Received: September 12, 2005
Last Updated: August 4, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nicola Goekbuget, Johann Wolfgang Goethe University Hospital:
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:
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Burkitt Lymphoma
Mediastinal Neoplasms
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Thoracic Neoplasms
Neoplasms by Site
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases
Lymphoma, T-Cell
Rituximab processed this record on September 18, 2017