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Multicenter Study to Evaluate the Combination of Oral Fludarabine, Mitoxantrone Und Rituximab Induction Therapy Und Rituximab Maintenance Therapy in Follicular B-Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Follicular T-NHL Lymphoma, Rituximab Maintenance

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Trial Information

Multicenter Study to Evaluate the Combination of Oral Fludarabine, Mitoxantrone Und Rituximab Induction Therapy Und Rituximab Maintenance Therapy in Follicular B-Cell Lymphoma


Inclusion Criteria:



- a positive BCL2/IgH rearrangement in peripheral blood (PB) and/or bone marrow (BM)

- clinical stage III or IV, requiring treatment with one or more of the following
criteria: symptoms related to the disease, hemoglobin less than 12 g/dL, platelets
less than 100 G/L, progressive disease, bulky tumor of more than 10 cm

Exclusion Criteria:

- pretreatment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

conversion rate of bcl-2 in blood and bone marrow defined by PCR

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Michael Fridirk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

AKH Linz

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

AGMT_NHL 9

NCT ID:

NCT01560117

Start Date:

January 2004

Completion Date:

July 2010

Related Keywords:

  • Follicular T-NHL Lymphoma
  • Rituximab Maintenance
  • AGMT
  • NHL
  • Lymphoma
  • Lymphoma, B-Cell

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