Trial Outcomes & Findings for A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma. (NCT NCT00472420)
NCT ID: NCT00472420
Last Updated: 2017-08-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome 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)
Results posted on
2017-08-15
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Induction Treatment Period
STARTED
|
48
|
|
Induction Treatment Period
COMPLETED
|
32
|
|
Induction Treatment Period
NOT COMPLETED
|
16
|
|
Follow-up Period
STARTED
|
32
|
|
Follow-up Period
COMPLETED
|
15
|
|
Follow-up Period
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Induction Treatment Period
Physician Decision
|
9
|
|
Induction Treatment Period
Adverse Event
|
3
|
|
Induction Treatment Period
Non-compliance
|
1
|
|
Induction Treatment Period
Death
|
3
|
|
Follow-up Period
Death
|
5
|
|
Follow-up Period
Physician Decision
|
9
|
|
Follow-up Period
Lost to Follow-up
|
2
|
|
Follow-up Period
Protocol Violation
|
1
|
Baseline Characteristics
A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.
Baseline characteristics by cohort
| Measure |
Rituximab + Chemotherapy
n=48 Participants
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).
|
|---|---|
|
Age, Continuous
|
70.20 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
PRIMARY outcome
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)Population: ITT population
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.
Outcome measures
| Measure |
Rituximab + Chemotherapy
n=48 Participants
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).
|
|---|---|
|
Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR)
CR
|
19 participants
|
|
Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR)
PR
|
8 participants
|
SECONDARY outcome
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)Population: ITT population
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.
Outcome measures
| Measure |
Rituximab + Chemotherapy
n=48 Participants
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).
|
|---|---|
|
Progression Free Survival (PFS)
|
30.456 months
Interval 19.011 to 41.901
|
SECONDARY outcome
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)Population: ITT population
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.
Outcome measures
| Measure |
Rituximab + Chemotherapy
n=48 Participants
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).
|
|---|---|
|
Event Free Survival (EFS)
|
40.049 months
Interval 33.296 to 46.802
|
Adverse Events
Rituximab + Chemotherapy
Serious events: 25 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab + Chemotherapy
n=48 participants at risk
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).
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.1%
1/48 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
4/48 • 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.
|
|
Infections and infestations
Septic shock
|
2.1%
1/48 • 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.
|
|
General disorders
Pyrexia
|
6.2%
3/48 • 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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
3/48 • 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.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
8.3%
4/48 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
6/48 • 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.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/48 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/48 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.1%
1/48 • 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.
|
|
Infections and infestations
Pneumonia
|
8.3%
4/48 • 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.
|
|
Infections and infestations
Sepsis
|
4.2%
2/48 • 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.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
2.1%
1/48 • 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.
|
|
Vascular disorders
Deep vein thrombosis
|
4.2%
2/48 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.2%
2/48 • 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.
|
|
Renal and urinary disorders
Renal failure acute
|
2.1%
1/48 • 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.
|
|
Infections and infestations
Sinusitis
|
2.1%
1/48 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurlopneumonia
|
2.1%
1/48 • 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.
|
|
Cardiac disorders
Arrythmia
|
2.1%
1/48 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
1/48 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.1%
1/48 • 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.
|
|
Vascular disorders
Haemorrhage
|
2.1%
1/48 • 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.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.1%
1/48 • 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.
|
|
Vascular disorders
Hypertensive crisis
|
2.1%
1/48 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.1%
1/48 • 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.
|
|
Surgical and medical procedures
Tumour excision
|
2.1%
1/48 • 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.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
2.1%
1/48 • 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.
|
|
Cardiac disorders
Acute coronaria syndrome
|
2.1%
1/48 • 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.
|
|
General disorders
Disease recurrence
|
2.1%
1/48 • 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.
|
|
Nervous system disorders
Transient ischaemic attack
|
2.1%
1/48 • 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.
|
|
Infections and infestations
Periproctal abscess
|
2.1%
1/48 • 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.
|
|
Skin and subcutaneous tissue disorders
Urticaria, perioral tingling
|
2.1%
1/48 • 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.
|
|
Cardiac disorders
Heart injury
|
2.1%
1/48 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progression of pre-existing cancer
|
2.1%
1/48 • 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.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
8.3%
4/48 • 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.
|
|
Infections and infestations
Encephalomalacia
|
2.1%
1/48 • 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.
|
Other adverse events
| Measure |
Rituximab + Chemotherapy
n=48 participants at risk
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).
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea infectious
|
2.1%
1/48 • 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.
|
|
Blood and lymphatic system disorders
Bacteremia
|
2.1%
1/48 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
4/48 • 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.
|
|
Infections and infestations
Herpes zoster
|
2.1%
1/48 • 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.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
10.4%
5/48 • 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.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.2%
2/48 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus cutaneous
|
2.1%
1/48 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
1/48 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
2/48 • 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.
|
|
Skin and subcutaneous tissue disorders
Toxicoderma
|
2.1%
1/48 • 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.
|
|
Infections and infestations
Helicobacter test positive
|
2.1%
1/48 • 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.
|
|
General disorders
Chills
|
8.3%
4/48 • 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.
|
|
General disorders
Pyrexia
|
6.2%
3/48 • 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.
|
|
General disorders
Chilliness
|
2.1%
1/48 • 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.
|
|
General disorders
Pain
|
2.1%
1/48 • 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.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • 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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/48 • 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.
|
|
Infections and infestations
Pneumonia
|
4.2%
2/48 • 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.
|
|
Infections and infestations
Oral thrush
|
2.1%
1/48 • 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.
|
|
Infections and infestations
Prostatitis
|
2.1%
1/48 • 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.1%
1/48 • 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.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
2.1%
1/48 • 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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.1%
1/48 • 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.
|
|
Vascular disorders
Thrombophlebitis
|
2.1%
1/48 • 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.
|
|
Renal and urinary disorders
Renal failure
|
2.1%
1/48 • 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.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
2.1%
1/48 • 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.
|
|
Infections and infestations
Gastroenteritis
|
2.1%
1/48 • 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.
|
|
Infections and infestations
Herpes labialis
|
2.1%
1/48 • 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.
|
|
Blood and lymphatic system disorders
Bone marrow toxicity
|
2.1%
1/48 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
1/48 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
2.1%
1/48 • 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.
|
|
Eye disorders
Ulcus corneae
|
2.1%
1/48 • 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.
|
|
Cardiac disorders
Carotid sinus syndrome
|
2.1%
1/48 • 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.
|
|
Gastrointestinal disorders
Choking sensation
|
2.1%
1/48 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER