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

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00199017

Collaborator

(none)

Enrollment

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Lymphoblastic	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	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Mar 1, 2009

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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