Trial Outcomes & Findings for Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy (NCT NCT02139280)
NCT ID: NCT02139280
Last Updated: 2021-02-16
Results Overview
the investigator will identify the number of cells collected within the apheresis products
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-02-16
Participant Flow
58 Individuals provided informed consent. Of those. four (4) participants were screen failures.
Participant milestones
| Measure |
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Arm 2: Cyclophosphamide 3 Gms/m(2)
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
20
|
|
Overall Study
COMPLETED
|
32
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Arm 2: Cyclophosphamide 3 Gms/m(2)
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
|---|---|---|
|
Overall Study
No longer eligible
|
2
|
0
|
Baseline Characteristics
Cyclophosphamide for Hematopoietic Stem Cell Mobilization in Patients With a Hematologic Malignancy
Baseline characteristics by cohort
| Measure |
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
n=32 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Arm 2: Cyclophosphamide 3 Gms/m(2)
n=20 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
n=5 Participants
|
61.3 years
n=7 Participants
|
61.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
20 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksthe investigator will identify the number of cells collected within the apheresis products
Outcome measures
| Measure |
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
n=32 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Arm 2: Cyclophosphamide 3 Gms/m(2)
n=20 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
|---|---|---|
|
Number of Nucleated Cells Collected Within the Apheresis Products
|
5.7 cells x10e10
Interval 2.9 to 15.5
|
3.8 cells x10e10
Interval 1.9 to 7.1
|
PRIMARY outcome
Timeframe: 6 weeksthe investigator will identify the number of CD34+ cells collected within the apheresis products
Outcome measures
| Measure |
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
n=32 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Arm 2: Cyclophosphamide 3 Gms/m(2)
n=20 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
|---|---|---|
|
Number of CD34+ Cells Collected Within the Apheresis Products
|
7 cells x10e8
Interval 2.2 to 49.9
|
10.5 cells x10e8
Interval 1.9 to 29.4
|
SECONDARY outcome
Timeframe: participants will be followed approximately 6 weeks following initiation of treatmentPopulation: Data was not collected due to the large geographic areas of the patient residence. It was too difficult to collect the date from multiple physicians from multiple states.
Resources used during the mobilization and apheresis processes will be captured.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: participants will be followed approximately 6 weeks following initiation of treatmentPopulation: Data was not collected due to the large geographic areas of the patient residence. It was too difficult to collect the date from multiple physicians from multiple states.
Resources used during the mobilization and apheresis processes will be captured.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: participants will be followed approximately 6 weeks following initiation of treatmentResources used during the mobilization and apheresis processes will be captured.
Outcome measures
| Measure |
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
n=32 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Arm 2: Cyclophosphamide 3 Gms/m(2)
n=20 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
|---|---|---|
|
Resource Utilization- Hospitalizations
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: participants will be followed approximately 6 weeks following initiation of treatmentResources used during the mobilization and apheresis processes will be captured.
Outcome measures
| Measure |
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
n=32 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Arm 2: Cyclophosphamide 3 Gms/m(2)
n=20 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
|---|---|---|
|
Resource Utilization- Incidence of Febrile Neutropenia
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: participants will be followed approximately 6 weeks following initiation of treatmentPopulation: Number of participants who experienced a grade 3 or higher adverse event
Toxicities during the mobilization and apheresis processes Grade 3 and higher
Outcome measures
| Measure |
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
n=32 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Arm 2: Cyclophosphamide 3 Gms/m(2)
n=20 Participants
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
|---|---|---|
|
Toxicities During the Mobilization and Apheresis Processes
|
4 Participants
|
7 Participants
|
Adverse Events
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm 2: Cyclophosphamide 3 Gms/m(2)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
n=33 participants at risk
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Arm 2: Cyclophosphamide 3 Gms/m(2)
n=20 participants at risk
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
|---|---|---|
|
Infections and infestations
Infection
|
3.0%
1/33 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
10.0%
2/20 • Number of events 2 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
Other adverse events
| Measure |
Arm 1: 1.5 Gms/m(2) Cyclophosphamide
n=33 participants at risk
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 1.5 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
Arm 2: Cyclophosphamide 3 Gms/m(2)
n=20 participants at risk
Patients will receive intravenous mesna 15 minutes prior to cyclophosphamide and again at 4 and 8 hours afterwards. Each infusion will be given over 15 minutes. Oral mesna can be substituted for the two post-cyclophosphamide doses. Oral mesna will be administered at 2 and 6 hours after the start of cyclophosphamide. Cyclophosphamide will be administered intravenously over one hour at the dose of 3 gms/m(2).
Cyclophosphamide: Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
|
|---|---|---|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/33 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
25.0%
5/20 • Number of events 5 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
5.0%
1/20 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Blood and lymphatic system disorders
Edema: limb
|
3.0%
1/33 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
5.0%
1/20 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
0.00%
0/33 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
5.0%
1/20 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
5.0%
1/20 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Cardiac disorders
Sinus tachycardia
|
3.0%
1/33 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
0.00%
0/20 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Cardiac disorders
Hypotension
|
3.0%
1/33 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
0.00%
0/20 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
3.0%
1/33 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
0.00%
0/20 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
0.00%
0/20 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
3.0%
1/33 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
0.00%
0/20 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain: Bone
|
18.2%
6/33 • Number of events 6 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
0.00%
0/20 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain: Extremity-limb
|
3.0%
1/33 • Number of events 1 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
0.00%
0/20 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain NOS
|
9.1%
3/33 • Number of events 3 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
0.00%
0/20 • Monitoring of toxicities will terminate on the last day of collection, since treatment-related toxicities occur during this time period. Patients who complete mobilization will be considered "off treatment" on the date of the last mobilization. There will be no specified follow up beyond the off treatment period other than following for engraftment. Average period of data collection was 10 days
Evaluation of toxicities (other than Hematologic) will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTC AE 4.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place