Clinical trial NCT00472420: A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.
Official title: An Open-label Study of the Effect of the Addition of MabThera to Standard Chemotherapy on Clinical Response in Patients With Previously Untreated Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-05-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* histologically-proven mantle cell lymphoma;
* previously untreated disease at stage II, III and IV, requiring therapy.

Exclusion Criteria:

* known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
* active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
* serious disorders interfering with full standard dosing chemotherapy;
* stage I disease.

Primary outcomes:
measure: Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR)
timeFrame: Screening, Baseline (BL), every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)
measure: Event Free Survival (EFS)
timeFrame: Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Institute of Oncology, A Dept of Internal Medicine
city: Debrecen
country: Hungary
facility: University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Korhaz; Hematologia
city: Kaposvar
country: Hungary
facility: Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Korhaz; Ii Belgyogyaszat
city: Szeged
country: Hungary
facility: University of Szeged, II Dept of Internal Medicine
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz; Ii. Belgyogyaszat
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: