Trial Outcomes & Findings for Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL (NCT NCT00504751)

Last Updated: 2017-04-07

Results Overview

Complete Response

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

26 months

Results posted on

2017-04-07

Participant milestones
Measure	Study Treatment This is a single arm study bortezomib, dexamethasone, ifosfamide: VIPER chemotherapy will be administered every 28 days at the following doses: * Dexamethasone 40 mg IV days 1-4 * Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4 * Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide) * Cisplatin 25 mg IV days 1-4 * Etoposide 100 mg/m2 CIVI over 24 hours days 1-4 * Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles) * VELCADE 1.5 mg/m2 on days 2 and 5 mesna, cisplatin, etoposide, rituximab: VIPER chemotherapy will be administered every 28 days at the following doses: * Dexamethasone 40 mg IV days 1-4 * Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4 * Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide) * Cisplatin 25 mg IV days 1-4 * Etoposide 100 mg/m2 CIVI over 24 hours days 1-4 * Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles) * VELCADE 1.5
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL

Baseline characteristics by cohort
Measure	Study Treatment n=15 Participants This is a single arm study
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

Timeframe: 26 months

Complete Response

Outcome measures
Measure	Study Treatment n=15 Participants This is a single arm study
Complete Response	3 participants

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Study Treatment n=15 participants at risk This is a single arm study
Blood and lymphatic system disorders Neutropenia	53.3% 8/15
Blood and lymphatic system disorders thrombocytopenia	46.7% 7/15
Blood and lymphatic system disorders Anemia	20.0% 3/15
Blood and lymphatic system disorders febrile neutropenia	20.0% 3/15
General disorders Nausea	6.7% 1/15
General disorders fatigue	6.7% 1/15
Gastrointestinal disorders mucositis	6.7% 1/15
Blood and lymphatic system disorders hypocalcemia	6.7% 1/15
Blood and lymphatic system disorders Hyponatremia	6.7% 1/15
Blood and lymphatic system disorders Hyperglycemia	6.7% 1/15

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