Trial Outcomes & Findings for Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma (NCT NCT00705250)

Last Updated: 2017-03-03

Results Overview

The percentage of evaluable participants who achieved either a complete response (CR) or partial response (PR). CR Disappearance of all evidence of disease. (a) FDGavid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT. PR Regression of measurable disease and no new sites. \> or = to 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

up to 3 years

Results posted on

2017-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion.
Overall Study STARTED	36
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion.
Overall Study Withdrawal by Subject	1
Overall Study Patient died in car accident	1

Baseline Characteristics

Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=36 Participants
Age, Continuous	34 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 years

Outcome measures

Outcome measures
Measure	All Participants n=34 Participants
Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL.	56 percentage of evaluable participants

Adverse Events

All Participants

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=36 participants at risk
General disorders Febrile neutropenia	5.6% 2/36
Respiratory, thoracic and mediastinal disorders Pneumonia	2.8% 1/36
Blood and lymphatic system disorders Self-limited Gross Hematuria	2.8% 1/36
Gastrointestinal disorders Vomiting	2.8% 1/36

Other adverse events

Other adverse events
Measure	All Participants n=36 participants at risk
Blood and lymphatic system disorders Thrombocytopenia	50.0% 18/36
Blood and lymphatic system disorders Anemia	13.9% 5/36
Blood and lymphatic system disorders Neutropenia	8.3% 3/36
General disorders Fatigue	83.3% 30/36
Gastrointestinal disorders Nausea	50.0% 18/36
Respiratory, thoracic and mediastinal disorders Cough	22.2% 8/36
Gastrointestinal disorders Vomiting	22.2% 8/36
Respiratory, thoracic and mediastinal disorders Dyspnea	19.4% 7/36
General disorders Fever	11.1% 4/36
General disorders Pneumonia	11.1% 4/36
Respiratory, thoracic and mediastinal disorders Respiratory Infection	8.3% 3/36
Gastrointestinal disorders Constipation	8.3% 3/36
Gastrointestinal disorders Mucositis	5.6% 2/36
General disorders Febrile Neutropenia	5.6% 2/36
General disorders Hematuria	5.6% 2/36

Additional Information

Craig Moskowitz, MD

Memorial Sloan Kettering Cancer Center

Phone: (212) 639-7992

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place