A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.
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|ClinicalTrials.gov Identifier: NCT00472420|
Recruitment Status : Completed
First Posted : May 11, 2007
Results First Posted : November 26, 2014
Last Update Posted : August 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: rituximab [MabThera/Rituxan] Drug: First line chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 27, 2007|
|Primary Completion Date :||May 25, 2011|
|Study Completion Date :||May 25, 2011|
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 3 weeksDrug: First line chemotherapy
- Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR) [ Time Frame: 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) ]CR was defined by: a) disappearance of clinical/radiographic evidence of disease, disease-related symptoms, and biochemical abnormalities; b) decrease in lymph nodes (LNs) greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) to less than (<) 1.5 cm, a decrease in LNs 1.1 - 1.5 cm to 1 cm or 75 percent (%) decrease in sum of the products of GTD (SPD); c) non-palpable spleen, decreased size of enlarged organs, and disappearance of nodules; and d) disappearance of bone marrow (BM) infiltrate. CR(u) was defined as fulfilling a) and c), above, with greater than or equal to (≥) 1 of the following: a) > 75% decrease in SPD of LNs > 1.5 cm, and > 75% decrease in SPD of previously confluent LNs; b) indeterminate BM, or c) confirmed CR. PR was defined by: a) 50% decrease in SPD of the 6 largest LNs; b) no increase in LNs, liver, or spleen size; c) ≥ 50% decrease in splenic and hepatic nodule SPDs; d) no measurable disease in other organs; and e) no new sites of disease.
- Progression Free Survival (PFS) [ Time Frame: 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) ]PFS was defined as the median time, in months, from the date of study entry to disease progression, death due to mantle cell lymphoma, or last contact. Progressive disease (PD) was defined by: a) 50% increase from nadir in the SPD of any previously identified abnormal LN, or b) appearance of any new lesion during or at the end of treatment. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.
- Event Free Survival (EFS) [ Time Frame: 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) ]EFS was defined as the median time, in months, from the date of study entry disease progression, relapse, secondary malignancy, death or last contact. Relapse was defined by: a) appearance of any new lesion or a ≥ 50% increase in size of previously involved sites, or b) ≥ 50% increase in GTD of any previously identified LN >1 cm in short axis or in the SPD of more than one LN. The 95% CI was estimated using Kaplan-Meier methodology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472420
|National Institute of Oncology, A Dept of Internal Medicine|
|Budapest, Hungary, 1122|
|University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology|
|Debrecen, Hungary, 4032|
|Petz Aladar Megyei Korhaz; Hematologia|
|Gyor, Hungary, 9024|
|Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology|
|Kaposvar, Hungary, 7400|
|Miskolci Semmelweis Korhaz; Ii Belgyogyaszat|
|Miskolc, Hungary, 3529|
|University of Szeged, II Dept of Internal Medicine|
|Szeged, Hungary, 6720|
|Zala Megyei Korhaz; Ii. Belgyogyaszat|
|Zalaegerszeg, Hungary, 8901|
|Study Director:||Clinical Trials||Hoffmann-La Roche|