Treatment protocol for elderly patients with mantle cell lymphoma (MCL). A phase II study of the Finnish Lymphoma Group.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003255-39-FI

Enrollment

Registered

2004-12-01

Start date

2005-02-08

Completion date

Unknown

Last updated

2015-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle cell lymphoma

Interventions

Trade Name: MabThera Product Name: MabThera

Rituximab Pharmaceutical Form: Intravenous infusion INN or Proposed INN: rituximab Concentration unit: mg milligram(s) Concentration number: 100-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria - Patients with histologically confirmed mantle cell lymphoma - Advanced stage II-IV - Previously untreated - 65 years and older, or 55-65 years if not eligible for high dose chemotherapy - Written informed consent - Adequate organ function - PS =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria - Severe somatic or psychiatric disease including cardiac, pulmonary, renal and CNS diseases, severe chronic infections, and active malignant diseases - Poor compliance

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this phase II study is to investigate whether the poor outcome in elderly patients with MCL could be improved by treatment schedule consisting of long induction with combination chemotherapy (alternating CHOP and intermediate-dose cytarabine, plus fludarabine in last three courses) combined with rituximab, and in patients with chemosensitive disease (PR or CR), of maintenance treatment with rituximab. ;Secondary Objective: ;Primary end point(s): Primary: Reduction of lymphoma mass measured by the CR rate, progression-free survival and overall survival Secondary: Progression-free survival and survival after maintenance therapy	—

Measure

Time frame

Main Objective: The aim of this phase II study is to investigate whether the poor outcome in elderly patients with MCL could be improved by treatment schedule consisting of long induction with combination chemotherapy (alternating CHOP and intermediate-dose cytarabine, plus fludarabine in last three courses) combined with rituximab, and in patients with chemosensitive disease (PR or CR), of maintenance treatment with rituximab. ;Secondary Objective: ;Primary end point(s): Primary: Reduction of lymphoma mass measured by the CR rate, progression-free survival and overall survival Secondary: Progression-free survival and survival after maintenance therapy

—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026