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Trial Outcomes & Findings for Bendamustine, Obinutuzumab, and Dexamethasone in Older Patients With Diffuse Large B-cell Lymphoma (NCT NCT02420210)

NCT ID: NCT02420210

Last Updated: 2018-06-06

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Up to 8 months

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure
Treatment (Bendamustine, Obinutuzumab, Dexamethasone)
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Bendamustine Hydrochloride: Given IV Obinutuzumab: Given IV Dexamethasone: Given PO Quality-of-Life Assessment: Ancillary studies Laboratory Biomarker Analysis: Correlative studies
Overall Study
STARTED
2
Overall Study
COMPLETED
2
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bendamustine, Obinutuzumab, and Dexamethasone in Older Patients With Diffuse Large B-cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment (Bendamustine, Obinutuzumab, Dexamethasone)
n=2 Participants
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Bendamustine Hydrochloride: Given IV Obinutuzumab: Given IV Dexamethasone: Given PO Quality-of-Life Assessment: Ancillary studies Laboratory Biomarker Analysis: Correlative studies
Age, Continuous
89.5 years
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
1 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
2 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure
Treatment (Bendamustine, Obinutuzumab, Dexamethasone)
n=2 Participants
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Bendamustine Hydrochloride: Given IV Obinutuzumab: Given IV Dexamethasone: Given PO Quality-of-Life Assessment: Ancillary studies Laboratory Biomarker Analysis: Correlative studies
ORR (PR + CR) Using the Cheson et al Parameters
2 Participants

SECONDARY outcome

Timeframe: Up to 40 months

Population: Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of study entry (date of first treatment) until death from any cause, assessed at 2 years

Population: Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.

Survival analyses will be performed according to Kaplan and Meier methods. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better OS. OS will also be stratified for bulky versus non-bulky disease comparisons (defined as any site with more than 5 cm in largest diameter).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of study entry (date of first treatment) until death from any cause, assessed at 3 years

Population: Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.

Survival analyses will be performed according to Kaplan and Meier methods. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better OS. OS will also be stratified for bulky versus non-bulky disease comparisons (defined as any site with more than 5 cm in largest diameter).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of study entry (date of first treatment) until progression, secondary malignancy, or death from any cause, assessed at 2 years

Population: Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.

Kaplan-Meier analysis will be performed. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better PFS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days following the last administration of study treatment

Population: Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.

Adverse events will be tabulated by type and grade.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 18 weeks (at end of study treatment)

Population: Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Bendamustine, Obinutuzumab, Dexamethasone)

Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Treatment (Bendamustine, Obinutuzumab, Dexamethasone)
n=2 participants at risk
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Bendamustine Hydrochloride: Given IV Obinutuzumab: Given IV Dexamethasone: Given PO Quality-of-Life Assessment: Ancillary studies Laboratory Biomarker Analysis: Correlative studies
Metabolism and nutrition disorders
Anorexia
50.0%
1/2 • 4 months
Gastrointestinal disorders
Diarrhea
50.0%
1/2 • 4 months

Other adverse events

Other adverse events
Measure
Treatment (Bendamustine, Obinutuzumab, Dexamethasone)
n=2 participants at risk
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone PO daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Bendamustine Hydrochloride: Given IV Obinutuzumab: Given IV Dexamethasone: Given PO Quality-of-Life Assessment: Ancillary studies Laboratory Biomarker Analysis: Correlative studies
Investigations
White blood cell decreased
50.0%
1/2 • 4 months
Infections and infestations
Upper resipiratory infection
50.0%
1/2 • 4 months

Additional Information

Theodore Karrison

University of Chicago

Phone: 773-702-9326

Results disclosure agreements

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