Trial Outcomes & Findings for Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma (NCT NCT00581854)

NCT ID: NCT00581854

Last Updated: 2019-12-13

Results Overview

Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: Median follow up of 37 months
• Results posted on: 2019-12-13

Participant Flow

Participant milestones

Measure	Rituximab Single Arm Maintenance rituximab following induction chemoimmunotherapy
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma

Baseline characteristics by cohort

Measure	Group 1 n=22 Participants SAEs during induction therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Median follow up of 37 months

Population: All Subjects enrolled were included in the analysis. Response rate is represented as % of total subjects enrolled.

Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999).

Outcome measures

Measure	Group 1 n=22 Participants All subjects received R-HyperCVAD induction therapy.
Complete Response Rate to Induction Therapy	64 percentage of participants Interval 44.0 to 80.0

Adverse Events

Group 1

Serious events: 8 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=22 participants at risk SAEs during induction therapy
Infections and infestations Infection with febrile neutropenia, Gr 3	9.1% 2/22 • Number of events 2
Blood and lymphatic system disorders Neutropenic Fever Gr 3	18.2% 4/22 • Number of events 4
Cardiac disorders Atrial fibrillation gr 3, dyspnea	4.5% 1/22 • Number of events 1
Infections and infestations perionitis, gr 5	4.5% 1/22 • Number of events 1
Infections and infestations psuedomonas sepsis, gr 5	4.5% 1/22 • Number of events 1
Metabolism and nutrition disorders Hyponatremia, gr 3	4.5% 1/22 • Number of events 1
Cardiac disorders Chronic Heart Failure, gr 5	4.5% 1/22 • Number of events 1

Other adverse events

Measure	Group 1 n=22 participants at risk SAEs during induction therapy
Blood and lymphatic system disorders Neutropenia	81.8% 18/22 • Number of events 59
Blood and lymphatic system disorders febrile neutropenia	18.2% 4/22 • Number of events 4
Infections and infestations infection with neutropenia	27.3% 6/22 • Number of events 6
Blood and lymphatic system disorders Thrombocytopenia	36.4% 8/22 • Number of events 24
Blood and lymphatic system disorders Anemia	36.4% 8/22 • Number of events 12
Metabolism and nutrition disorders Hyperglycemia	18.2% 4/22 • Number of events 9
General disorders dehydration	4.5% 1/22 • Number of events 3

Additional Information

Brad S Kahl, MD

University of Wisconsin

Phone: 608-263-1836

Email: bsk@medicine.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place