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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

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
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199082
First received: September 12, 2005
Last updated: May 29, 2008
Last verified: May 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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

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 ClinicalTrials.gov identifier: NCT00199082

Contacts
Contact: Dieter Hoelzer, MD, PhD ++49(0)69 6301 5194 hoelzer@em.uni-frankfurt.de
Contact: Nicola Goekbuget, MD ++49(0)69 6301 6365 goekbuget@em.uni-frankfurt.de

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

No publications provided by Johann Wolfgang Goethe University Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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
 Chemotherapy
Rituximab
Primary mediastinal diffuse large cell lymphoma
B-precursor lymphoblastic lymphoma

Additional relevant MeSH terms:
Burkitt Lymphoma
Lymphoma
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, B-Cell
Lymphoma, T-Cell
Leukemia
Mediastinal Neoplasms
DNA Virus Infections
Epstein-Barr Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunoproliferative Disorders
Leukemia, Lymphoid
 Lymphatic Diseases
Lymphoproliferative Disorders
Mediastinal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Experimental
Respiratory Tract Diseases
Thoracic Diseases
Thoracic Neoplasms
Tumor Virus Infections
Virus Diseases
Cyclophosphamide
Dexamethasone
Methotrexate

ClinicalTrials.gov processed this record on February 25, 2015