Trial Outcomes & Findings for 10-Propargyl-10-Deazaaminopterin in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma (NCT NCT00052442)
NCT ID: NCT00052442
Last Updated: 2021-08-25
Results Overview
Per Response Evaluation Criteria in T-cell and B-cell Lymphoma for target lesions and assessed using computerized tomography (CT) and or Positron emission tomography CT (PET CT) by local investigators: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
72 participants
Primary outcome timeframe
3 weeks
Results posted on
2021-08-25
Participant Flow
Participant milestones
| Measure |
135 mg/m^2 Pralatrexate 1/2 Weeks
Pralatrexate 135 mg/m\^2 administered as an IV infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
|
30 mg/m^2 Pralatrexate 3/4 Weeks
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
|
30 mg/m^2 Pralatrexate 6/7 Weeks
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
45 mg/m^2 Pralatrexate 6/7 Weeks
Pralatrexate 45 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
270 mg/m^2 Pralatrexate 2/4 Weeks
Pralatrexate 270 mg/m\^2 administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
3
|
27
|
11
|
15
|
|
Overall Study
COMPLETED
|
16
|
3
|
27
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
10-Propargyl-10-Deazaaminopterin in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
135 mg/m2 Pralatrexate 1/2 Weeks
n=16 Participants
Pralatrexate 135 mg/m\^2 administered as an IV infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
|
30 mg/m2 Pralatrexate 3/4 Weeks
n=3 Participants
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
|
30 mg/m2 Pralatrexate 6/7 Weeks
n=27 Participants
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
45 mg/m2 Pralatrexate 6/7 Weeks
n=11 Participants
Pralatrexate 45 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
270 mg/m2 Pralatrexate 2/4 Weeks
n=15 Participants
Pralatrexate 270 mg/m\^2 administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
57.1 years
STANDARD_DEVIATION 15.1 • n=21 Participants
|
54.1 years
STANDARD_DEVIATION 15.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPer Response Evaluation Criteria in T-cell and B-cell Lymphoma for target lesions and assessed using computerized tomography (CT) and or Positron emission tomography CT (PET CT) by local investigators: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
135 mg/m^2 Pralatrexate 1/2 Weeks
n=16 Participants
Pralatrexate 135 mg/m\^2 administered as an IV infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
|
30 mg/m^2 Pralatrexate 3/4 Weeks
n=3 Participants
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
|
30 mg/m^2 Pralatrexate 6/7 Weeks
n=27 Participants
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
45 mg/m^2 Pralatrexate 6/7 Weeks
n=11 Participants
Pralatrexate 45 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
270 mg/m^2 Pralatrexate 2/4 Weeks
n=15 Participants
Pralatrexate 270 mg/m\^2 administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.
|
|---|---|---|---|---|---|
|
Response Rate
|
15 Participants
|
3 Participants
|
27 Participants
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 3 weeksAdverse events; number of patients with at least one adverse events reported.
Outcome measures
| Measure |
135 mg/m^2 Pralatrexate 1/2 Weeks
n=16 Participants
Pralatrexate 135 mg/m\^2 administered as an IV infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
|
30 mg/m^2 Pralatrexate 3/4 Weeks
n=3 Participants
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
|
30 mg/m^2 Pralatrexate 6/7 Weeks
n=27 Participants
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
45 mg/m^2 Pralatrexate 6/7 Weeks
n=11 Participants
Pralatrexate 45 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
270 mg/m^2 Pralatrexate 2/4 Weeks
n=15 Participants
Pralatrexate 270 mg/m\^2 administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.
|
|---|---|---|---|---|---|
|
Toxicities of Pralatrexate
|
16 Participants
|
3 Participants
|
27 Participants
|
11 Participants
|
15 Participants
|
Adverse Events
135 mg/m^2 Pralatrexate 1/2 Weeks
Serious events: 8 serious events
Other events: 8 other events
Deaths: 0 deaths
30 mg/m^2 Pralatrexate 3/4 Weeks
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
30 mg/m^2 Pralatrexate 6/7 Weeks
Serious events: 15 serious events
Other events: 12 other events
Deaths: 0 deaths
45 mg/m^2 Pralatrexate 6/7 Weeks
Serious events: 10 serious events
Other events: 1 other events
Deaths: 0 deaths
270 mg/m^2 Pralatrexate 2/4 Weeks
Serious events: 10 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
135 mg/m^2 Pralatrexate 1/2 Weeks
n=16 participants at risk
Pralatrexate 135 mg/m\^2 administered as an IV infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
|
30 mg/m^2 Pralatrexate 3/4 Weeks
n=3 participants at risk
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
|
30 mg/m^2 Pralatrexate 6/7 Weeks
n=27 participants at risk
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
45 mg/m^2 Pralatrexate 6/7 Weeks
n=11 participants at risk
Pralatrexate 45 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
270 mg/m^2 Pralatrexate 2/4 Weeks
n=15 participants at risk
Pralatrexate 270 mg/m\^2 administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
37.5%
6/16 • Number of events 6
|
0.00%
0/3
|
11.1%
3/27 • Number of events 3
|
27.3%
3/11 • Number of events 3
|
20.0%
3/15 • Number of events 3
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/16
|
0.00%
0/3
|
11.1%
3/27 • Number of events 3
|
9.1%
1/11 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
12.5%
2/16 • Number of events 2
|
0.00%
0/3
|
0.00%
0/27
|
9.1%
1/11 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16
|
0.00%
0/3
|
0.00%
0/27
|
9.1%
1/11 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia & Thrombocytopenia
|
0.00%
0/16
|
33.3%
1/3 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
36.4%
4/11 • Number of events 4
|
13.3%
2/15 • Number of events 2
|
|
General disorders
General Disorders
|
0.00%
0/16
|
0.00%
0/3
|
22.2%
6/27
|
0.00%
0/11
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/16
|
0.00%
0/3
|
3.7%
1/27 • Number of events 1
|
0.00%
0/11
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
135 mg/m^2 Pralatrexate 1/2 Weeks
n=16 participants at risk
Pralatrexate 135 mg/m\^2 administered as an IV infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
|
30 mg/m^2 Pralatrexate 3/4 Weeks
n=3 participants at risk
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
|
30 mg/m^2 Pralatrexate 6/7 Weeks
n=27 participants at risk
Pralatrexate 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
45 mg/m^2 Pralatrexate 6/7 Weeks
n=11 participants at risk
Pralatrexate 45 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.
|
270 mg/m^2 Pralatrexate 2/4 Weeks
n=15 participants at risk
Pralatrexate 270 mg/m\^2 administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
8/16 • Number of events 8
|
66.7%
2/3
|
44.4%
12/27
|
9.1%
1/11
|
33.3%
5/15
|
Additional Information
Owen A. O'Connor, MD, PhD
Memorial Sloan-Kettering Cancer Center
Phone: 212-639-8889
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place