Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1)
Phase 4
15 Years
65 Years
15 Years
65 Years
Not Enrolling
Both
Lymphoma, Lymphoblastic
Both
Lymphoma, Lymphoblastic
Trial Information
Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
remission rate, remission duration, disease free survival, overall survival
Principal Investigator
Dieter Hoelzer, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Frankfurt, Medical Dept. II
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
GMALL04
NCT ID:
NCT00199017
Start Date:
April 2004
Completion Date:
Related Keywords:
- Lymphoma, Lymphoblastic
- T-LBL
- Treatment
- De novo
- Chemotherapy
- Adult
- Lymphoma, lymphoblastic, T-cell
- Lymphoma
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma, Non-Hodgkin
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