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

J

Johann Wolfgang Goethe University Hospital

Status and phase

Completed
Phase 4

Conditions

Lymphoma, Lymphoblastic

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00199017
GMALL04

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

15 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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