Trial Outcomes & Findings for Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia (NCT NCT00014560)
NCT ID: NCT00014560
Last Updated: 2018-05-03
Results Overview
This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
TERMINATED
PHASE1
3 participants
day 1-29
2018-05-03
Participant Flow
Participant milestones
| Measure |
Single Arm
This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If \> 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Single Arm
n=3 Participants
This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If \> 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 1-29Population: This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1-29This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 Hours 0,2,4,6,24, day 15 Hours 0,2,4,6,24This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
Outcome measures
Outcome data not reported
Adverse Events
Single Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pamela Ely
Dartmouth Hitchcock
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place