Trial Outcomes & Findings for Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell (NCT NCT00656084)
NCT ID: NCT00656084
Last Updated: 2016-11-03
Results Overview
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
2 years
Results posted on
2016-11-03
Participant Flow
Participant milestones
| Measure |
Gemzar + Novantrone + Rituxan
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Gemzar + Novantrone + Rituxan
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Patient Request
|
1
|
|
Overall Study
Investigator Request
|
1
|
Baseline Characteristics
Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
Baseline characteristics by cohort
| Measure |
Gemzar + Novantrone + Rituxan
n=16 Participants
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
|
|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Evaluable Population
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Gemzar + Novantrone + Rituxan
n=15 Participants
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
|
|---|---|
|
Objective Response Rate (CR + PR)
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.Population: For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.
The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Gemzar + Novantrone + Rituxan
n=7 Participants
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
|
|---|---|
|
Duration of Response
|
7.9 months
Interval 4.8 to 31.3
|
SECONDARY outcome
Timeframe: 1 year.Population: ITT population
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Outcome measures
| Measure |
Gemzar + Novantrone + Rituxan
n=16 Participants
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
|
|---|---|
|
Overall Survival (OS) Rate at 1 Year
|
0.57 Probability of Survival
Interval 0.28 to 0.78
|
SECONDARY outcome
Timeframe: 1 year.Population: ITT population
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Outcome measures
| Measure |
Gemzar + Novantrone + Rituxan
n=16 Participants
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
|
|---|---|
|
Progression-free Survival Rate at 1 Year.
|
0.54 Probability of Progression-free Survival
Interval 0.24 to 0.77
|
Adverse Events
Gemzar + Novantrone + Rituxan
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemzar + Novantrone + Rituxan
n=15 participants at risk
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
|
|---|---|
|
General disorders
CACHEXIA
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
FEVER
|
13.3%
2/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
PAIN ABDO
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
Other adverse events
| Measure |
Gemzar + Novantrone + Rituxan
n=15 participants at risk
Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
|
|---|---|
|
Gastrointestinal disorders
ABDO ENLARGE
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Immune system disorders
ALLERG REACT
|
13.3%
2/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
20.0%
3/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
ANEMIA
|
86.7%
13/15 • Number of events 49 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
ANOREXIA
|
46.7%
7/15 • Number of events 10 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
ASTHENIA
|
93.3%
14/15 • Number of events 35 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
BILIRUBINEM
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
BUN INC
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Infections and infestations
CELLULITIS
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
CHILLS
|
13.3%
2/15 • Number of events 4 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
CONSTIP
|
40.0%
6/15 • Number of events 7 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH INC
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
CREATININE INC
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
DEHYDRAT
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
DEPRESSION
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
DIARRHEA
|
13.3%
2/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Nervous system disorders
DIZZINESS
|
20.0%
3/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
DRY MOUTH
|
20.0%
3/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
20.0%
3/15 • Number of events 5 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
EDEMA PERIPH
|
6.7%
1/15 • Number of events 4 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
FEVER
|
20.0%
3/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
FLATUL
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
FLU SYND
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
HEADACHE
|
6.7%
1/15 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Renal and urinary disorders
HEMATURIA
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
HYPERGLYCEM
|
13.3%
2/15 • Number of events 4 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
HYPERURICEM
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
HYPOCALCEM
|
13.3%
2/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
HYPONATREM
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
HYPOPROTEINEM
|
13.3%
2/15 • Number of events 4 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
HYPOVOLEM
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Infections and infestations
INFECT
|
13.3%
2/15 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
INSOMNIA
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
LAB TEST ABNORM
|
6.7%
1/15 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
LDH INC
|
13.3%
2/15 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
60.0%
9/15 • Number of events 50 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Skin and subcutaneous tissue disorders
MUCOUS MEM DIS
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
13.3%
2/15 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
NAUSEA
|
60.0%
9/15 • Number of events 15 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
100.0%
15/15 • Number of events 64 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
PAIN
|
20.0%
3/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
PAIN ABDO
|
13.3%
2/15 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Musculoskeletal and connective tissue disorders
PAIN BONE
|
6.7%
1/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Investigations
PAIN CHEST SUBSTERN
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Investigations
PALLOR
|
6.7%
1/15 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Metabolism and nutrition disorders
PHOSPHATASE ALK INC
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Investigations
PLAT ABNORM
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
13.3%
2/15 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Skin and subcutaneous tissue disorders
RASH
|
20.0%
3/15 • Number of events 4 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
RECTAL DIS
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
STOMATITIS
|
6.7%
1/15 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
SWEAT
|
13.3%
2/15 • Number of events 4 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
TASTE PERVERS
|
20.0%
3/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
THROMBOCYTHEM
|
6.7%
1/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
80.0%
12/15 • Number of events 63 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Investigations
VASODILAT
|
6.7%
1/15 • Number of events 1 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
Gastrointestinal disorders
VOMIT
|
13.3%
2/15 • Number of events 3 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
|
General disorders
WEIGHT DEC
|
13.3%
2/15 • Number of events 2 • During the whole treatment period, up to 30 days following last dose.
For treated patients only, assessed at each treatment visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place