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A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-Cell Lymphoma: NHL-13


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Diffuse Large B-Cell Lymphoma (DLBCL), Follicular NHL Grade 3b

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Trial Information

A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-Cell Lymphoma: NHL-13


Inclusion Criteria:



- 4 to 8 cycles R-CHOP/like, total of 8x Rituximab

- CR, CRu

- ECOG/ 0.1 or 2

- Known IPI at time of diagnosis

- Age > 18 years

- Negative pregnancy test

- Men must agree not to father a child during the therapy

Exclusion Criteria:

- Transformed lymphoma

- Secondary malignancy

- Evidence of CNS - involvement

- Significant cardiac disease

- Creatinine > 2.0 mg/dl

- HIV, Hepatitis positive

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

event free survival

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Ulrich Jaeger, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Vienna

Authority:

Austria: Ethikkommission

Study ID:

NHL-13 (ML18223)

NCT ID:

NCT00400478

Start Date:

January 2006

Completion Date:

December 2012

Related Keywords:

  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Follicular NHL Grade 3b
  • DLBCL
  • NHL 13
  • Rituximab
  • maintenance
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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