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 - Full Text View

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:

European Leukemia Trial Registry This link exits the ClinicalTrials.gov site

German Leukemia Trial Registry This link exits the ClinicalTrials.gov site

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

Hoelzer D, Walewski J, Döhner H, Viardot A, Hiddemann W, Spiekermann K, Serve H, Dührsen U, Hüttmann A, Thiel E, Dengler J, Kneba M, Schaich M, Schmidt-Wolf IG, Beck J, Hertenstein B, Reichle A, Domanska-Czyz K, Fietkau R, Horst HA, Rieder H, Schwartz S, Burmeister T, Gökbuget N; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Improved outcome of adult Burkitt lymphoma/leukemia with rituximab and chemotherapy: report of a large prospective multicenter trial. Blood. 2014 Dec 18;124(26):3870-9. doi: 10.1182/blood-2014-03-563627. Epub 2014 Oct 30.


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 September 27, 2016