Follicular T-NHL Lymphoma Clinical Trial
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
| Verified date | January 2018 |
| Source | Arbeitsgemeinschaft medikamentoese Tumortherapie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | July 2010 |
| Est. primary completion date | July 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Arbeitsgemeinschaft medikamentoese Tumortherapie |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | conversion rate of bcl-2 in blood and bone marrow defined by PCR | 3 years | ||
| Secondary | Number of patients with a response after 8 weeks |