Trial Outcomes & Findings for Alemtuzumab and Pentostatin In T-cell Neoplasms (NCT NCT00453193)
NCT ID: NCT00453193
Last Updated: 2012-08-07
Results Overview
Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month.
TERMINATED
PHASE2
26 participants
After a maximum of 6 months of therapy maintained for one month.
2012-08-07
Participant Flow
Recruitment Period: 8/241/2004 to 5/12/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.
Of the 26 enrolled, only 24 patients were included in this study.
Participant milestones
| Measure |
Alemtuzumab + Pentostatin
Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alemtuzumab and Pentostatin In T-cell Neoplasms
Baseline characteristics by cohort
| Measure |
Alemtuzumab + Pentostatin
n=24 Participants
Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks
|
|---|---|
|
Age Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After a maximum of 6 months of therapy maintained for one month.Population: Analysis was per protocol.
Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month.
Outcome measures
| Measure |
Alemtuzumab + Pentostatin
n=24 Participants
Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks
|
|---|---|
|
Number of Participants With Objective Response
Complete Response
|
11 Participants
|
|
Number of Participants With Objective Response
Partial Response
|
2 Participants
|
Adverse Events
Alemtuzumab + Pentostatin
Serious adverse events
| Measure |
Alemtuzumab + Pentostatin
n=24 participants at risk
Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks
|
|---|---|
|
Hepatobiliary disorders
elevated asparatate aminotransferase
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Infections and infestations
Bacteremia
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Infections and infestations
Pneumonia
|
12.5%
3/24 • Number of events 4 • 5 years 2 months
|
|
General disorders
Death
|
33.3%
8/24 • Number of events 8 • 5 years 2 months
|
|
Cardiac disorders
Myocardial Infarction
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
2/24 • Number of events 2 • 5 years 2 months
|
|
Infections and infestations
Neutropenic Fever
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Blood and lymphatic system disorders
Subdural Hematoma
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Infections and infestations
sinusitis
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Infections and infestations
non neutropenic fever
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Hepatobiliary disorders
increased liver function
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Nervous system disorders
headache
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
General disorders
fever
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Blood and lymphatic system disorders
Epididymitis
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
|
Infections and infestations
viral infection
|
4.2%
1/24 • Number of events 1 • 5 years 2 months
|
Other adverse events
| Measure |
Alemtuzumab + Pentostatin
n=24 participants at risk
Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks
|
|---|---|
|
General disorders
Hives
|
37.5%
9/24 • Number of events 9 • 5 years 2 months
|
|
General disorders
Edema
|
12.5%
3/24 • Number of events 3 • 5 years 2 months
|
|
General disorders
fatugue
|
25.0%
6/24 • Number of events 6 • 5 years 2 months
|
|
Gastrointestinal disorders
Nausea
|
62.5%
15/24 • Number of events 15 • 5 years 2 months
|
|
Hepatobiliary disorders
Hepatic
|
29.2%
7/24 • Number of events 7 • 5 years 2 months
|
|
Eye disorders
Ocular
|
8.3%
2/24 • Number of events 2 • 5 years 2 months
|
|
General disorders
Pain
|
29.2%
7/24 • Number of events 7 • 5 years 2 months
|
|
Renal and urinary disorders
Renal
|
20.8%
5/24 • Number of events 5 • 5 years 2 months
|
|
General disorders
tumor lysis syndrome
|
8.3%
2/24 • Number of events 2 • 5 years 2 months
|
Additional Information
Farhad Ravandi-Kashani MD/Associate Professor
The University of Texas M D Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place