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

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1)

Conditions
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Lymphoma, Lymphoblastic

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dexamethasone/Prednisolone|nan|
|Drug: Cyclophosphamide|nan|
|Drug: Vincristine|nan|
|Drug: Daunorubicin|nan|
|Drug: Asparaginase|nan|
|Drug: G-CSF|nan|
|Drug: Mercaptopurine|nan|
|Drug: Cytarabine|nan|
|Drug: Methotrexate|nan|
|Drug: VP16|nan|
|Drug: Vindesine|nan|
|Drug: Adriamycin|nan|
|Drug: Thioguanine|nan|
|Drug: HDARAC|nan|
|Procedure: CNS irradiation|nan|
|Procedure: Mediastinal irradiation|nan|
|Drug: Cladribine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate, remission duration, disease free survival, overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time and dose compliance, toxicity according to World Health Organization (WHO) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment, De novo, T-LBL, Chemotherapy, Adult, Lymphoma, lymphoblastic, T-cell