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

Phase 4CompletedNCT00199017

Johann Wolfgang Goethe University Hospital75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, Lymphoblastic

Interventions

Dexamethasone/PrednisoloneDRUG

CyclophosphamideDRUG

VincristineDRUG

DaunorubicinDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital, Medical Dept. II

Frankfurt, Germany

Outcomes

Primary Outcomes

remission rate, remission duration, disease free survival, overall survival

Secondary Outcomes

time and dose compliance, toxicity according to World Health Organization (WHO)

Data from ClinicalTrials.gov

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