Back to resultsGerman Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults
Primary Purpose
Lymphoma, Lymphoblastic
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Dexamethasone/Prednisolone
Cyclophosphamide
Vincristine
Daunorubicin
Asparaginase
G-CSF
Mercaptopurine
Cytarabine
Methotrexate
VP16
Vindesine
Adriamycin
Thioguanine
HDARAC
CNS irradiation
Mediastinal irradiation
Cladribine
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Lymphoblastic focused on measuring T-LBL, Treatment, De novo, Chemotherapy, Adult, Lymphoma, lymphoblastic, T-cell
Eligibility 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
Sites / Locations
- University Hospital, Medical Dept. II
Outcomes
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)
Full Information
NCT ID
NCT00199017
First Posted
September 12, 2005
Last Updated
August 20, 2010
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00199017
Brief Title
German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Lymphoblastic
Keywords
T-LBL, Treatment, De novo, Chemotherapy, Adult, Lymphoma, lymphoblastic, T-cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dexamethasone/Prednisolone
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention Type
Drug
Intervention Name(s)
Asparaginase
Intervention Type
Drug
Intervention Name(s)
G-CSF
Intervention Type
Drug
Intervention Name(s)
Mercaptopurine
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
VP16
Intervention Type
Drug
Intervention Name(s)
Vindesine
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Intervention Type
Drug
Intervention Name(s)
Thioguanine
Intervention Type
Drug
Intervention Name(s)
HDARAC
Intervention Type
Procedure
Intervention Name(s)
CNS irradiation
Intervention Type
Procedure
Intervention Name(s)
Mediastinal irradiation
Intervention Type
Drug
Intervention Name(s)
Cladribine
Primary Outcome Measure Information:
Title
remission rate, remission duration, disease free survival, overall survival
Secondary Outcome Measure Information:
Title
time and dose compliance, toxicity according to World Health Organization (WHO)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Hoelzer, MD, PhD
Organizational Affiliation
University Hospital Frankfurt, Medical Dept. II
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital, Medical Dept. II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.leukemia-trials.eu
Description
European Leukemia Trial Registry
Learn more about this trial
German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults
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