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

NCT01560117 | Completed Phase 2

• 1 other identifier: AGMT_NHL 9
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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

Keywords

AGMT; NHL

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (1)

• Number of patients with a response after 8 weeks

Interventions

Rituximab DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pretreatment

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead

Related Publications (1)

• 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.

  PMID: 22511498 DERIVED

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michael Fridirk, MD

  AKH Linz

  PRINCIPAL INVESTIGATOR

• Ulrich Jäger

  AKH Wien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 22, 2012
• Study Start: January 1, 2004
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2010
• Last Updated: January 9, 2018

Record last verified: 2018-01