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

NCT ID: NCT01560117

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2010-07-31

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.

Conditions

Follicular T-NHL Lymphoma; Rituximab Maintenance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Interventions

Rituximab

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Fridirk, MD

Role: PRINCIPAL_INVESTIGATOR

AKH Linz

Ulrich Jäger

Role: PRINCIPAL_INVESTIGATOR

AKH Wien

References

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.

Reference Type: DERIVED

PMID: 22511498 (View on PubMed)

Other Identifiers

AGMT_NHL 9

Identifier Type: -

Identifier Source: org_study_id