Trial Outcomes & Findings for A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma. (NCT NCT01144403)

Last Updated: 2016-10-18

Results Overview

Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Up to 50 months (approximately)

Results posted on

2016-10-18

Participant Flow

A total 8 participants were enrolled from Romania.

Participant milestones

Participant milestones
Measure	Rituximab Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). Cyclophosphamide: as prescribed, 6 cycles Fludarabine: as prescribed, 6 cycles Mitoxantrone: as prescribed, 6 cycles Rituximab \[Mabthera/Rituxan\]: 375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
Overall Study STARTED	8
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). Cyclophosphamide: as prescribed, 6 cycles Fludarabine: as prescribed, 6 cycles Mitoxantrone: as prescribed, 6 cycles Rituximab \[Mabthera/Rituxan\]: 375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
Overall Study Lost to Follow-up	3
Overall Study Death	1
Overall Study Adverse Event	1

Baseline Characteristics

A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=8 Participants Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). Cyclophosphamide: as prescribed, 6 cycles Fludarabine: as prescribed, 6 cycles Mitoxantrone: as prescribed, 6 cycles Rituximab \[Mabthera/Rituxan\]: 375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
Age, Continuous	60.50 years STANDARD_DEVIATION 7.964 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 50 months (approximately)

Population: Efficacy population included all the participants who had received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Rituximab n=8 Participants Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy for mantle cell lymphoma. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). cyclophosphamide: as prescribed, 6 cycles fludarabine: as prescribed, 6 cycles mitoxantrone: as prescribed, 6 cycles rituximab \[Mabthera/Rituxan\]: 375 mg/m\^2 intravenously, day 1 of each 28-day cycle, up to 8 cycles
Overall Response Rate (ORR)	87.5 percentage of participants

SECONDARY outcome

Timeframe: From the time of enrollment until death due to any cause (up to 50 months [approximately])

Population: Efficacy population included all the participants who had received at least one dose of study treatment.

Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.

Outcome measures

Outcome measures
Measure	Rituximab n=8 Participants Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy for mantle cell lymphoma. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). cyclophosphamide: as prescribed, 6 cycles fludarabine: as prescribed, 6 cycles mitoxantrone: as prescribed, 6 cycles rituximab \[Mabthera/Rituxan\]: 375 mg/m\^2 intravenously, day 1 of each 28-day cycle, up to 8 cycles
Overall Survival (OS)	927 days Interval 0.0 to 2204.066

SECONDARY outcome

Timeframe: From the time of enrollment until death due to any cause (up to 50 months [approximately])

Population: Efficacy population included all the participants who had received at least one dose of study treatment.

PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Rituximab n=8 Participants Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy for mantle cell lymphoma. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). cyclophosphamide: as prescribed, 6 cycles fludarabine: as prescribed, 6 cycles mitoxantrone: as prescribed, 6 cycles rituximab \[Mabthera/Rituxan\]: 375 mg/m\^2 intravenously, day 1 of each 28-day cycle, up to 8 cycles
Progression-free Survival (PFS)	653 days Interval 537.058 to 768.942

SECONDARY outcome

Timeframe: Up to 50 months (approximately)

Population: Safety population included all the participants who had received at least one dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.

Outcome measures

Outcome measures
Measure	Rituximab n=8 Participants Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy for mantle cell lymphoma. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). cyclophosphamide: as prescribed, 6 cycles fludarabine: as prescribed, 6 cycles mitoxantrone: as prescribed, 6 cycles rituximab \[Mabthera/Rituxan\]: 375 mg/m\^2 intravenously, day 1 of each 28-day cycle, up to 8 cycles
Number of Participant With Adverse Event (AE)	8 participants

Adverse Events

Rituximab

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab n=8 participants at risk Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). Cyclophosphamide: as prescribed, 6 cycles Fludarabine: as prescribed, 6 cycles Mitoxantrone: as prescribed, 6 cycles Rituximab \[Mabthera/Rituxan\]: 375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
Infections and infestations Pneumonia	12.5% 1/8 • Up to approximately 50 months
Infections and infestations Neutropenia	12.5% 1/8 • Up to approximately 50 months
Injury, poisoning and procedural complications Toxicity	12.5% 1/8 • Up to approximately 50 months

Other adverse events

Other adverse events
Measure	Rituximab n=8 participants at risk Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles). Cyclophosphamide: as prescribed, 6 cycles Fludarabine: as prescribed, 6 cycles Mitoxantrone: as prescribed, 6 cycles Rituximab \[Mabthera/Rituxan\]: 375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
Blood and lymphatic system disorders Anemia	37.5% 3/8 • Up to approximately 50 months
Blood and lymphatic system disorders Leucopenia	50.0% 4/8 • Up to approximately 50 months
Gastrointestinal disorders Gastric Pain	12.5% 1/8 • Up to approximately 50 months
Vascular disorders Ascending Aorta Dilatation	12.5% 1/8 • Up to approximately 50 months
Injury, poisoning and procedural complications Drug Eruption	25.0% 2/8 • Up to approximately 50 months
Skin and subcutaneous tissue disorders Dermatitis Eczematous	12.5% 1/8 • Up to approximately 50 months
Respiratory, thoracic and mediastinal disorders Tracheitis	12.5% 1/8 • Up to approximately 50 months
Blood and lymphatic system disorders Neutropenia	25.0% 2/8 • Up to approximately 50 months
Metabolism and nutrition disorders Hyperglycemia	12.5% 1/8 • Up to approximately 50 months
Hepatobiliary disorders Hepatitis Ag HBS+	12.5% 1/8 • Up to approximately 50 months
Infections and infestations Herpes	12.5% 1/8 • Up to approximately 50 months
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • Up to approximately 50 months
Nervous system disorders Vertiginous syndrome	12.5% 1/8 • Up to approximately 50 months
Cardiac disorders Supraventricular arrhythmia	12.5% 1/8 • Up to approximately 50 months
Respiratory, thoracic and mediastinal disorders Respiratory Virosis	12.5% 1/8 • Up to approximately 50 months
Infections and infestations Oral Candidiasis	12.5% 1/8 • Up to approximately 50 months
Blood and lymphatic system disorders Thrombocytopenia	62.5% 5/8 • Up to approximately 50 months
Blood and lymphatic system disorders ß2-microglobuline ↗	12.5% 1/8 • Up to approximately 50 months
Blood and lymphatic system disorders C- reactive protein	12.5% 1/8 • Up to approximately 50 months

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

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