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

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199017
First received: September 12, 2005
Last updated: August 20, 2010
Last verified: May 2008
  Purpose

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 Intervention 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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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:
  • time and dose compliance, toxicity according to World Health Organization (WHO)

Estimated Enrollment: 75
Study Start Date: April 2004
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
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
  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: NCT00199017

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

No publications provided

ClinicalTrials.gov Identifier: NCT00199017     History of Changes
Other Study ID Numbers: GMALL04
Study First Received: September 12, 2005
Last Updated: August 20, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Methotrexate
Dexamethasone
Asparaginase
Daunorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on October 19, 2014