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

NCT ID: NCT00199017

Last Updated: 2010-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

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.

Detailed Description

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Conditions

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Lymphoma, Lymphoblastic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Dexamethasone/Prednisolone

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Daunorubicin

Intervention Type DRUG

Asparaginase

Intervention Type DRUG

G-CSF

Intervention Type DRUG

Mercaptopurine

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

VP16

Intervention Type DRUG

Vindesine

Intervention Type DRUG

Adriamycin

Intervention Type DRUG

Thioguanine

Intervention Type DRUG

HDARAC

Intervention Type DRUG

CNS irradiation

Intervention Type PROCEDURE

Mediastinal irradiation

Intervention Type PROCEDURE

Cladribine

Intervention Type DRUG

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Dieter Hoelzer, MD, PhD

Role: STUDY_CHAIR

University Hospital Frankfurt, Medical Dept. II

Locations

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University Hospital, Medical Dept. II

Frankfurt, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.studienregister-online.de

German Leukemia Trial Registry

Other Identifiers

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GMALL04

Identifier Type: -

Identifier Source: org_study_id

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