- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00199017
German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults
August 20, 2010 updated by: Johann Wolfgang Goethe University Hospital
Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Drug: Methotrexate
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Cytarabine
- Drug: G-CSF
- Drug: Cladribine
- Drug: Daunorubicin
- Drug: Mercaptopurine
- Drug: Asparaginase
- Drug: Vindesine
- Drug: VP16
- Drug: Adriamycin
- Drug: Thioguanine
- Procedure: CNS irradiation
- Drug: Dexamethasone/Prednisolone
- Drug: HDARAC
- Procedure: Mediastinal irradiation
Study Type
Interventional
Enrollment (Anticipated)
75
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Frankfurt, Germany, 60590
- University Hospital, Medical Dept. II
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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remission rate, remission duration, disease free survival, overall survival
|
Secondary Outcome Measures
Outcome Measure |
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time and dose compliance, toxicity according to World Health Organization (WHO)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
August 23, 2010
Last Update Submitted That Met QC Criteria
August 20, 2010
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia
- Lymphoma
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Antibiotics, Antineoplastic
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Dexamethasone
- Prednisolone
- Cyclophosphamide
- Doxorubicin
- Cytarabine
- Methotrexate
- Vincristine
- Daunorubicin
- Asparaginase
- Mercaptopurine
- Cladribine
- Thioguanine
- Vindesine
Other Study ID Numbers
- GMALL04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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