Lymphoma, Lymphoblastic Clinical Trial
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)
| NCT number | NCT00199017 |
| Other study ID # | GMALL04 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | September 12, 2005 |
| Last updated | August 20, 2010 |
| Start date | April 2004 |
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.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years to 65 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital, Medical Dept. II | Frankfurt |
| Lead Sponsor | Collaborator |
|---|---|
| Johann Wolfgang Goethe University Hospitals |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | remission rate, remission duration, disease free survival, overall survival | |||
| Secondary | time and dose compliance, toxicity according to World Health Organization (WHO) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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