- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00472420
A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.
July 6, 2017 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Budapest, Hungary, 1122
- National Institute of Oncology, A Dept of Internal Medicine
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Debrecen, Hungary, 4032
- University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
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Gyor, Hungary, 9024
- Petz Aladar Megyei Korhaz; Hematologia
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Kaposvar, Hungary, 7400
- Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
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Miskolc, Hungary, 3529
- Miskolci Semmelweis Korhaz; Ii Belgyogyaszat
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Szeged, Hungary, 6720
- University of Szeged, II Dept of Internal Medicine
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Zalaegerszeg, Hungary, 8901
- Zala Megyei Korhaz; Ii. Belgyogyaszat
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
375mg/m2 iv every 3 weeks
As prescribed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
|
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.
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2007
Primary Completion (Actual)
May 25, 2011
Study Completion (Actual)
May 25, 2011
Study Registration Dates
First Submitted
May 10, 2007
First Submitted That Met QC Criteria
May 10, 2007
First Posted (Estimate)
May 11, 2007
Study Record Updates
Last Update Posted (Actual)
August 15, 2017
Last Update Submitted That Met QC Criteria
July 6, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- ML20493
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mantle Cell Lymphoma
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Northwestern UniversityNational Cancer Institute (NCI); Janssen Scientific Affairs, LLCActive, not recruitingStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedRecurrent Mantle Cell Lymphoma | Stage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
-
National Cancer Institute (NCI)CompletedStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell Lymphoma | Stage I Mantle Cell LymphomaUnited States
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Burzynski Research InstituteWithdrawnRecurrent Mantle Cell Lymphoma | Stage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Contiguous Stage II Mantle Cell Lymphoma | Noncontiguous Stage II Mantle Cell LymphomaUnited States
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Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedStage III Mantle Cell Lymphoma | Stage IV Mantle Cell Lymphoma | Stage I Mantle Cell Lymphoma | Stage II Contiguous Mantle Cell Lymphoma | Stage II Non-Contiguous Mantle Cell LymphomaUnited States
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University of WashingtonNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell Lymphoma | Ann Arbor Stage I Mantle Cell Lymphoma | Ann Arbor Stage II Mantle Cell Lymphoma | Ann Arbor Stage III Mantle Cell Lymphoma | Ann Arbor Stage IV Mantle Cell LymphomaUnited States
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BeiGeneRecruitingMantle Cell Lymphoma | Relapsed Mantle Cell Lymphoma | Refractory Mantle Cell Lymphoma (MCL)United States, China, Israel, Belgium, Poland, Spain, Turkey, Brazil, Italy, Canada, United Kingdom, France, Germany, Argentina
-
BeiGeneCompletedRefractory Mantle Cell Lymphoma | Relapsed Mantle Cell LymphomaChina
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Mantle Cell Lymphoma | Recurrent Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Refractory Mantle Cell Lymphoma | Central Nervous System Lymphoma | Gastric Mantle Cell Lymphoma | Splenic Mantle Cell LymphomaUnited States
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Fondazione Italiana Linfomi - ETSRecruitingRefractory Mantle Cell Lymphoma | Relapsed Mantle Cell LymphomaItaly
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