Trial Outcomes & Findings for Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma (NCT NCT00823797)
NCT ID: NCT00823797
Last Updated: 2017-07-07
Results Overview
Defined as the proportion of patients who remain alive and free of any disease progression at 6 months. PFS over time will be estimated using the Kaplan-Meier method with standard errors estimated using Greenwood's formula.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
At 6 months
Results posted on
2017-07-07
Participant Flow
Participant milestones
| Measure |
Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma
Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Treatment (Bendamustine Hydrochloride) for Glioblastoma
Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
16
|
|
Overall Study
COMPLETED
|
29
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Baseline characteristics by cohort
| Measure |
Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma
n=29 Participants
Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Treatment (Bendamustine Hydrochloride) for Glioblastoma
n=16 Participants
Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsDefined as the proportion of patients who remain alive and free of any disease progression at 6 months. PFS over time will be estimated using the Kaplan-Meier method with standard errors estimated using Greenwood's formula.
Outcome measures
| Measure |
Treatment (Bendamustine Hydrochloride) for Glioblastoma
n=16 Participants
Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma
n=29 Participants
Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
PFS-6
|
1 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to progression or death, whichever came first, assessed up to 108 monthsDefined as the time from date of initial therapy to first objective documentation of tumor progression or death.
Outcome measures
| Measure |
Treatment (Bendamustine Hydrochloride) for Glioblastoma
n=16 Participants
Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma
n=29 Participants
Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
PFS
|
1.0 months
Interval -0.5 to 2.6
|
2.6 months
Interval -1.0 to 6.3
|
SECONDARY outcome
Timeframe: Up to 30 days after completion of study treatmentDefined as death that is possibly, probably, or definitely attributed to bendamustine hydrochloride.
Outcome measures
| Measure |
Treatment (Bendamustine Hydrochloride) for Glioblastoma
n=16 Participants
Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma
n=29 Participants
Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Toxic Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Until death or last reported survival\*inclusive of subjects still alive at time of last reporting.
Outcome measures
| Measure |
Treatment (Bendamustine Hydrochloride) for Glioblastoma
n=16 Participants
Glioblastoma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma
n=29 Participants
Anaplastic Glioma Arm
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
18.3 months
Interval 8.2 to 28.4
|
45.6 months
Interval 33.6 to 57.7
|
Adverse Events
Treatment (Bendamustine Hydrochloride)
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Bendamustine Hydrochloride)
n=45 participants at risk
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.4%
2/45 • Number of events 2
|
|
Immune system disorders
Allergic Reaction
|
2.2%
1/45 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Bendamustine Hydrochloride)
n=45 participants at risk
Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Bendamustine Hydrochloride: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
80.0%
36/45
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
9/45
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place