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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab [MabThera/Rituxan] | Drug | 375mg/m2 iv every 3 weeks |
| |
| First line chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR) | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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. |
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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 |
|---|---|---|---|---|---|---|
| National Institute of Oncology, A Dept of Internal Medicine | Budapest | 1122 | Hungary | |||
| University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab Plus (+) Chemotherapy | Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or orally (PO), on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, every 12 hours (q12h) on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Treatment Period |
|
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| Drug |
As prescribed |
|
| 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) | 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) |
| Debrecen |
| 4032 |
| Hungary |
| Petz Aladar Megyei Korhaz; Hematologia | Győr | 9024 | Hungary |
| Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology | Kaposvár | 7400 | Hungary |
| Miskolci Semmelweis Korhaz; Ii Belgyogyaszat | Miskolc | 3529 | Hungary |
| University of Szeged, II Dept of Internal Medicine | Szeged | 6720 | Hungary |
| Zala Megyei Korhaz; Ii. Belgyogyaszat | Zalaegerszeg | 8901 | Hungary |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
Intent-to-treat (ITT) population: all randomized participants who received at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab + Chemotherapy | Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 47 participants were included in the calculation of age. | Median | Full Range | years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR) | 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. | ITT population | Posted | Number | participants | 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 | Progression Free Survival (PFS) | 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. | ITT population | Posted | Median | 95% Confidence Interval | months | 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) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Event Free Survival (EFS) | 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. | ITT population | Posted | Median | 95% Confidence Interval | months | 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) |
|
Adverse events (AEs) were recorded throughout the study up to 3 months after the last study drug administration.
All participants who received at least 1 dose of study treatment were included in the safety analysis.
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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 + Chemotherapy | Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies: CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5. OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15. Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses). | 25 | 48 | 23 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pleurlopneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Arrythmia | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Tumour excision | Surgical and medical procedures | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Acute coronaria syndrome | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Disease recurrence | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Periproctal abscess | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Urticaria, perioral tingling | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Heart injury | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Progression of pre-existing cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | Non-systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Encephalomalacia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea infectious | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bacteremia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pruritus cutaneous | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Toxicoderma | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Helicobacter test positive | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Chilliness | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Oral thrush | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Prostatitis | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | CTCAE (2.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Herpes labialis | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Bone marrow toxicity | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Ulcus corneae | Eye disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Carotid sinus syndrome | Cardiac disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Choking sensation | Gastrointestinal disorders | CTCAE (2.0) | 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 | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| 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
Not provided
| 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
| Protocol Violation |
|
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|
|
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