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Completed

NCT Number: NCT00199017

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

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.

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Key information

Conditions

Lymphoma, Lymphoblastic Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

CNS irradiation

Procedure

Mediastinal irradiation

Procedure

cladribine

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2009
First posted
Sep 20, 2005
Registry last updated
Aug 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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