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.
Sponsor:
Information provided by (Responsible Party):
Nicola Goekbuget, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier:
NCT00199082
First received: September 12, 2005
Last updated: August 4, 2016
Last verified: August 2016
  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:


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

Primary Outcome Measures:
  • Remission rate [ Designated as safety issue: No ]
  • Remission duration [ Designated as safety issue: No ]
  • Disease free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dose and time compliance [ Designated as safety issue: No ]
  • Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) [ Designated as safety issue: Yes ]
  • Death under therapy and in complete remission (CR) [ Designated as safety issue: No ]
  • Localisations of relapse [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
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

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nicola Goekbuget, Dr. med., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT00199082     History of Changes
Other Study ID Numbers: GMALL05 
Study First Received: September 12, 2005
Last Updated: August 4, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Johann Wolfgang Goethe University Hospital:
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:
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Burkitt Lymphoma
Mediastinal Neoplasms
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
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
Dexamethasone
Prednisolone
Cyclophosphamide
Rituximab

ClinicalTrials.gov processed this record on August 25, 2016