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German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults

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ClinicalTrials.gov Identifier: NCT00199017
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 23, 2010
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:
This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year of intensive cyclical chemotherapy with additional prophylaxis for central nervous system (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation after induction chemotherapy.

Condition or disease Intervention/treatment Phase
Lymphoma, Lymphoblastic Drug: Dexamethasone/Prednisolone Drug: Cyclophosphamide Drug: Vincristine Drug: Daunorubicin Drug: Asparaginase Drug: G-CSF Drug: Mercaptopurine Drug: Cytarabine Drug: Methotrexate Drug: VP16 Drug: Vindesine Drug: Adriamycin Drug: Thioguanine Drug: HDARAC Procedure: CNS irradiation Procedure: Mediastinal irradiation Drug: Cladribine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1)
Study Start Date : April 2004
Primary Completion Date : March 2009





Primary Outcome Measures :
  1. remission rate, remission duration, disease free survival, overall survival

Secondary Outcome Measures :
  1. time and dose compliance, toxicity according to World Health Organization (WHO)


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T-lymphoblastic lymphoma (bone marrow [BM] involvement < 25%)
  • Aged 15-65 years (55-65 years if biologically younger)
  • Written informed consent

Exclusion Criteria:

  • Severe complications due to lymphoma or secondary disease
  • T-LBL as second malignancy or other active second malignancy
  • Cytostatic pretreatment of LBL (exception of emergency treatments)
  • Pregnancy
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
  • Participation in other study interfering with study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199017


Locations
Germany
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Study Chair: Dieter Hoelzer, MD, PhD University Hospital Frankfurt, Medical Dept. II

Additional Information:
ClinicalTrials.gov Identifier: NCT00199017     History of Changes
Other Study ID Numbers: GMALL04
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 23, 2010
Last Verified: May 2008

Keywords provided by Johann Wolfgang Goethe University Hospital:
T-LBL
Treatment
De novo
Chemotherapy
Adult
Lymphoma, lymphoblastic, T-cell

Additional relevant MeSH terms:
Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Dexamethasone
Prednisolone
Cyclophosphamide
Methotrexate
Cytarabine
Vincristine
Doxorubicin
Daunorubicin
Asparaginase
6-Mercaptopurine
Cladribine
Thioguanine
Vindesine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents