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This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is <3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MabThera/Rituxan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab [MabThera/Rituxan] | Drug | 375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR) | Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL. PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. | Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Clinical Response | Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cologne | 50924 | Germany | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
| Time to Best Response | The median time, in months, from start of the treatment (first application) until best response (PR or CR). | Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
| Duration of Remission | Median time, in months, between the documentation of CR or PR and PD in clinical responders. | Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
| Time to Progression | The median time, in months, from the start of treatment (first application) until detection of PD. | Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
| Overall Survival (OS) | OS was defined as the time, in months, between enrollment into the study and death, due to any cause. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. | Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
| Number of Participants With a Clinical Response to Re-Treatment | Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD. CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%. | First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months). |
| Erlangen |
| 91054 |
| Germany |
| Göttingen | 37075 | Germany |
| Grenzach-Wyhlen | 79639 | Germany |
| Hanover | 30625 | Germany |
| Homburg/saar | 66424 | Germany |
| München | 80336 | Germany |
| München | 81377 | Germany |
| Münster | 48129 | Germany |
| Stuttgart | 70376 | Germany |
| Tübingen | 72076 | Germany |
| 1st Treatment Cycle Completed Until PD |
|
| 2nd Treatment Cycle Started |
|
| 2nd Treatment Cycle Completed Until PD |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat (ITT) population included all participants with at least 1 application of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | National Institutes of Health (NIH), Office of Management and Budget (OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Ann Arbor stage | A staging system for lymphomas based on the location of the tumor and on systemic symptoms, ranging from stage I to stage IV. Stage III indicated that the cancer had spread to both sides of the diaphragm, including 1 organ or area near the lymph nodes or the spleen. Stage IV indicated diffuse or disseminated involvement of 1 or more extra-lymphatic organs, including any involvement of the liver, bone marrow, or nodular involvement of the lungs. | Number | participants |
| ||||||||||||||||||||||
| Histological subtype | Histological subtype as confirmed by central pathologic review. | Number | participants |
| ||||||||||||||||||||||
| B-Symptoms | B-Symptoms included high temperatures [greater than (>) 38 degrees Celsius (C)], night sweats, and unintentional weight loss >10 percent (%) over a period of 6 months or less. | Number | participants |
| ||||||||||||||||||||||
| Bulky disease | Bulky disease was defined as at least 1 lesion ≥ 5 centimeters (cm) in diameter. | Number | participants |
| ||||||||||||||||||||||
| Bone marrow involvement | Number | participants |
| |||||||||||||||||||||||
| Liver involvement | Number | participants |
| |||||||||||||||||||||||
| Spleen involvement | Number | participants |
| |||||||||||||||||||||||
| Other extra-nodal lesions | Number | participants |
| |||||||||||||||||||||||
| Number of previous therapies | Number of previous therapies since diagnosis of lymphoma. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR) | Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL. PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Number of Participants With a Clinical Response | Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%. | ITT population | Posted | Number | participants | Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Best Response | The median time, in months, from start of the treatment (first application) until best response (PR or CR). | ITT population; only participants with at least one application of study treatment within the first 4 weeks of treatment were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Remission | Median time, in months, between the documentation of CR or PR and PD in clinical responders. | Participants in the ITT population with CR or PR after the first treatment cycle. | Posted | Median | 95% Confidence Interval | months | Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Progression | The median time, in months, from the start of treatment (first application) until detection of PD. | ITT population | Posted | Median | 95% Confidence Interval | months | Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time, in months, between enrollment into the study and death, due to any cause. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. | ITT population | Posted | Median | 95% Confidence Interval | months | Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With a Clinical Response to Re-Treatment | Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD. CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%. | Participants in the ITT population who began a second cycle of treatment. | Posted | Number | participants | First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months). |
|
Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab | Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse. | 10 | 38 | 34 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy | Immune system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Lymphocytes | Blood and lymphatic system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Dysrhythmias | Cardiac disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Lethargy (fatigue, malaise) | General disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Shortness of breath (including wheezing) | Respiratory, thoracic and mediastinal disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobine | Blood and lymphatic system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Lymphocytes | Blood and lymphatic system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| White blood count | Blood and lymphatic system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Blood/bone marrow: other (not specified) | Blood and lymphatic system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Dysrhythmias | Cardiac disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Esophagitis/dysphagia/odonophagia (including recall reaction) | Gastrointestinal disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Vomitting | Gastrointestinal disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Gastrointestinal: other (not specified) | Gastrointestinal disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Fever in absence of infection (including drug fever) | General disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Lethargy (fatigue, malaise) | General disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Myalgia | General disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Rigor/chills (grade 3 including cyanosis) | General disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Flue-like symptoms: other (not specified) | General disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Alkaline phosphatase | Hepatobiliary disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Bilirubin | Hepatobiliary disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Lactate dehydrogenase (LDH) | Hepatobiliary disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Alanine transaminase (ALT) | Hepatobiliary disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Hepatic: other (not specified) | Hepatobiliary disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Allergy | Immune system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Coagulation: other (not specified) | Investigations | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Metabolic: other (not specified) | Metabolism and nutrition disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Sensory | Nervous system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Neurologic: other (not specified) | Nervous system disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Genitourinary: other (not specifed) | Renal and urinary disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Shortness of breath (including wheezing) | Respiratory, thoracic and mediastinal disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Rash/itch (not due to allergy, including recall reaction) | Skin and subcutaneous tissue disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Skin: other (not specified) | Skin and subcutaneous tissue disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Edema | Vascular disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | NCI-CTC v. 21Dec1994 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Greater Than or Equal to (≥) 65 Years |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Missing |
|
| 3 previous therapies |
|
| Counts |
|---|
| Participants |
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| Units |
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| Counts |
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| Participants |
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