Trial Outcomes & Findings for Allogeneic Stem Cell Transplant for CLL (NCT NCT01629511)
NCT ID: NCT01629511
Last Updated: 2020-02-24
Results Overview
Number of deaths related to treatment by day 100 post allogeneic transplant
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
100 days post transplant
Results posted on
2020-02-24
Participant Flow
Participants enrolled at MD Anderson clinic starting on November 21, 2012 on Phase I of the study. No participants were enrolled on Phase II.
Participant milestones
| Measure |
Gemcitabine Dose Level 1
Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 2
Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 3
Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 4
Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
8
|
3
|
|
Overall Study
COMPLETED
|
4
|
0
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allogeneic Stem Cell Transplant for CLL
Baseline characteristics by cohort
| Measure |
Gemcitabine Dose Level 1
n=4 Participants
Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 2
Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 3
n=8 Participants
Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 4
n=3 Participants
Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Continuous
|
56 years
n=5 Participants
|
—
|
57.5 years
n=5 Participants
|
60 years
n=4 Participants
|
59 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Disease Category
Diseases : Chronic Lymphocytic Leukemia (CLL)
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Disease Category
Diseases : Prolymphocytic Leukemia (PLL)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Disease Category
Diseases: Richter's
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 100 days post transplantPopulation: No participants were treated at dose level 2.
Number of deaths related to treatment by day 100 post allogeneic transplant
Outcome measures
| Measure |
Gemcitabine Dose Level 1
n=4 Participants
Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 2
Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 3
n=8 Participants
Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 4
n=3 Participants
Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
|---|---|---|---|---|
|
100 Day Treatment Related Mortality (TRM)
Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
100 Day Treatment Related Mortality (TRM)
Graft versus Host Disease (GVHD)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Enrollment up to day 30 post transplantPopulation: MTD analysis was for Phase II. Data were not collected.
To find the maximum tolerated dose (MTD) of Gemcitabine when administered with Busulfan \& Clofarabine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 year post transplantPopulation: All participants were registered on Phase I.
Will be estimated by the method of Kaplan and Meier. Time-to-event distributions as function of patient baseline covariates will be evaluated using Bayesian time-to-event regression modeling.
Outcome measures
| Measure |
Gemcitabine Dose Level 1
n=4 Participants
Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 2
Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 3
n=8 Participants
Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 4
n=3 Participants
Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
|---|---|---|---|---|
|
Overall Survival
|
3 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 year post transplantPopulation: Analysis was for Phase II. No analysis was done due to low accrual on Phase I.
Number of patients without any relapse post treatment completion
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post transplantPopulation: No participants were treated at dose level 2.
The number of days until participants by dose level reach engraftment.
Outcome measures
| Measure |
Gemcitabine Dose Level 1
n=4 Participants
Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 2
Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 3
n=8 Participants
Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 4
n=3 Participants
Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
|---|---|---|---|---|
|
Time-to-engraftment
Day 10
|
1 participants
|
—
|
2 participants
|
0 participants
|
|
Time-to-engraftment
Day 11
|
2 participants
|
—
|
4 participants
|
0 participants
|
|
Time-to-engraftment
Day 12
|
1 participants
|
—
|
0 participants
|
1 participants
|
|
Time-to-engraftment
Day 13
|
0 participants
|
—
|
1 participants
|
0 participants
|
|
Time-to-engraftment
Day 15
|
0 participants
|
—
|
0 participants
|
1 participants
|
|
Time-to-engraftment
Day 17
|
0 participants
|
—
|
0 participants
|
1 participants
|
|
Time-to-engraftment
<10 days - Graft Failure
|
0 participants
|
—
|
1 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 year post transplantPopulation: Analysis was for Phase II. No analysis was done due to low accrual on Phase I.
GvHD (Graft versus Host Disease) occurs when immune cells transplanted from a non-identical donor (graft) recognizes the transplant recipient (the host) as foreign, thereby initiating an immune reaction in the transplant recipient. Acute GvHD typically occurs around the time of engraftment and manifests in skin, GI system, and liver abnormalities. Chronic GvHD is defined by manifestations such as ocular, oral, lung, sclerosis skin, failure to thrive, fascia, cholestasis in liver, esophagus strictures.
Outcome measures
Outcome data not reported
Adverse Events
Gemcitabine Dose Level 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Gemcitabine Dose Level 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gemcitabine Dose Level 3
Serious events: 0 serious events
Other events: 8 other events
Deaths: 1 deaths
Gemcitabine Dose Level 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gemcitabine Dose Level 1
n=4 participants at risk
Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 2
Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 3
n=8 participants at risk
Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
Gemcitabine Dose Level 4
n=3 participants at risk
Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant
|
|---|---|---|---|---|
|
Cardiac disorders
Hypertension
|
100.0%
4/4 • Number of events 4 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
12.5%
1/8 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
33.3%
1/3 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
General disorders
Fluid Overload
|
100.0%
4/4 • Number of events 4 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
62.5%
5/8 • Number of events 5 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
100.0%
3/3 • Number of events 3 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
General disorders
Fever
|
100.0%
4/4 • Number of events 5 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
12.5%
1/8 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
66.7%
2/3 • Number of events 2 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
50.0%
4/8 • Number of events 4 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
66.7%
2/3 • Number of events 2 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Gastrointestinal disorders
Mucositis
|
100.0%
4/4 • Number of events 4 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
75.0%
6/8 • Number of events 6 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
66.7%
2/3 • Number of events 2 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
100.0%
8/8 • Number of events 8 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
100.0%
3/3 • Number of events 3 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Renal and urinary disorders
Elevated Creatinine
|
50.0%
2/4 • Number of events 2 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
0.00%
0/8 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
33.3%
1/3 • Number of events 2 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
25.0%
1/4 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
0.00%
0/8 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
0.00%
0/3 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Hepatobiliary disorders
Transaminitis
|
75.0%
3/4 • Number of events 5 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
75.0%
6/8 • Number of events 6 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
100.0%
3/3 • Number of events 4 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Hepatobiliary disorders
Elevated Bilirubin
|
75.0%
3/4 • Number of events 3 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
62.5%
5/8 • Number of events 5 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
33.3%
1/3 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Infections and infestations
Infection
|
100.0%
4/4 • Number of events 8 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
100.0%
8/8 • Number of events 15 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
100.0%
3/3 • Number of events 7 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
General disorders
Neutropenic Fever
|
75.0%
3/4 • Number of events 3 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
87.5%
7/8 • Number of events 7 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
66.7%
2/3 • Number of events 2 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Nervous system disorders
Headaches
|
0.00%
0/4 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
25.0%
2/8 • Number of events 2 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
33.3%
1/3 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
1/4 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
12.5%
1/8 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
0.00%
0/3 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
75.0%
3/4 • Number of events 3 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
50.0%
4/8 • Number of events 4 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
33.3%
1/3 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
General disorders
Acute Graft versus Host Disease
|
75.0%
3/4 • Number of events 5 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
37.5%
3/8 • Number of events 7 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
66.7%
2/3 • Number of events 5 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
General disorders
Chronic Graft versus Host Disease
|
50.0%
2/4 • Number of events 3 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
37.5%
3/8 • Number of events 8 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
66.7%
2/3 • Number of events 8 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Blood and lymphatic system disorders
Secondary Graft Failure
|
0.00%
0/4 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
12.5%
1/8 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
33.3%
1/3 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
|
Blood and lymphatic system disorders
Primary Graft Failure
|
0.00%
0/4 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
—
0/0 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
12.5%
1/8 • Number of events 1 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
0.00%
0/3 • Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place