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Combination of Oral Fludarabine, Mitoxantrone Und Rituximab Induction Therapy and Rituximab Maintenance Therapy in Follicular B-Cell Lymphoma

Primary Purpose

Follicular T-NHL Lymphoma, Rituximab Maintenance

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Rituximab

About this trial

This is an interventional treatment trial for Follicular T-NHL Lymphoma focused on measuring AGMT, NHL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients with a response after 8 weeks

Full Information

NCT ID

NCT01560117

First Posted

March 16, 2012

Last Updated

January 8, 2018

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

1. Study Identification

Unique Protocol Identification Number

NCT01560117

Brief Title

Combination of Oral Fludarabine, Mitoxantrone Und Rituximab Induction Therapy and Rituximab Maintenance Therapy in Follicular B-Cell Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Immunotherapy with the monoclonal anti-CD20 antibody rituximab has become standard of care for patients with follicular lymphoma. However, there are still open questions regarding dosing and scheduling of rituximab, optimal type of chemotherapeutic combination partners during induction as well as the best interval and length of rituximab maintenance treatment. Fludarabine-mitoxantrone combinations have shown strong debulking activity as initial therapy followed by rituximab maintenance. While rituximab maintenance with a standard dose of 375 mg/m2 prolongs clinical remissions, administration schedules still vary: Three-monthly infusions for 2 years and two-monthly infusions for one or 2 years are most frequently used. A few pharmacokinetic data for rituximab have been reported for induction treatment. These studies have proposed a presumptive "active" level of 25.000 ng/ml in anti-lymphoma treatment. However, there is only limited information regarding maintenance treatment in patients who are in remission and have no remaining tumor load. The aim of this trial is to investigate the effect of treatment with oral Fludarabine, Mitoxantrone und Rituximab and Rituximab maintenance on the depth of remission measured by BCL2/IgH PCR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Follicular T-NHL Lymphoma, Rituximab Maintenance

Keywords

AGMT, NHL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

Rituximab 375 mg/m2 i.v. every 2 months for 24 months

Primary Outcome Measure Information:

Title

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Number of patients with a response after 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Fridirk, MD

Organizational Affiliation

AKH Linz

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ulrich Jäger

Organizational Affiliation

AKH Wien

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

22511498

Citation

Jager U, Fridrik M, Zeitlinger M, Heintel D, Hopfinger G, Burgstaller S, Mannhalter C, Oberaigner W, Porpaczy E, Skrabs C, Einberger C, Drach J, Raderer M, Gaiger A, Putman M, Greil R; Arbeitsgemeinschaft Medikamentose Tumortherapie (AGMT) Investigators. Rituximab serum concentrations during immuno-chemotherapy of follicular lymphoma correlate with patient gender, bone marrow infiltration and clinical response. Haematologica. 2012 Sep;97(9):1431-8. doi: 10.3324/haematol.2011.059246. Epub 2012 Apr 17.

Results Reference

derived

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Combination of Oral Fludarabine, Mitoxantrone Und Rituximab Induction Therapy and Rituximab Maintenance Therapy in Follicular B-Cell Lymphoma

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