Trial Outcomes & Findings for Multi-Ctr PII Cmb.Modality Tx Ruxolitinib, Decitabine, and DLI for Post HSCT in AML/MDS (NCT NCT04055844)
NCT ID: NCT04055844
Last Updated: 2023-11-07
Results Overview
Rate of Overall Survival (OS)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
6 Months
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Decitabine + Ruxolitinib + DLI
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Decitabine + Ruxolitinib + DLI
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Poor Performance
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Multi-Ctr PII Cmb.Modality Tx Ruxolitinib, Decitabine, and DLI for Post HSCT in AML/MDS
Baseline characteristics by cohort
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsRate of Overall Survival (OS)
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Efficacy of Combined Modality Treatment (Ruxolitinib, Decitabine, and DLI) for Relapsed AML or MDS Post Allo-HCT: Rate of Overall Survival (OS)
|
36 Percentage of participants
Interval 18.0 to 72.0
|
SECONDARY outcome
Timeframe: 1 YearRate of Overall Survival (OS)
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Efficacy of Combined Modality Treatment (Ruxolitinib, Decitabine, and DLI) for Relapsed AML or MDS Post Allo-HCT: Rate of Overall Survival (OS)
|
14 Percentage of participants
Interval 4.0 to 52.0
|
SECONDARY outcome
Timeframe: 3 MonthsPercentage of Participants with Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)
|
43 Percentage of participants
Interval 17.0 to 67.0
|
SECONDARY outcome
Timeframe: 6 MonthsRate of Progression Free Survival (PFS)
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Progression Free Survival (PFS)
|
14 Percentage of participants with PFS
Interval 4.0 to 52.0
|
SECONDARY outcome
Timeframe: 1 YearRate of Progression Free Survival (PFS)
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Progression Free Survival (PFS)
|
7 Percentage of participants
Interval 1.0 to 47.0
|
SECONDARY outcome
Timeframe: 6 MonthsCumulative Incidence of Relapse
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Relapse
|
71 Percentage of participants
Interval 37.0 to 89.0
|
SECONDARY outcome
Timeframe: 1 YearCumulative Incidence of Relapse
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Relapse
|
79 Percentage of participants
Interval 41.0 to 94.0
|
SECONDARY outcome
Timeframe: 6 MonthsRate of Complete Remission (CR)
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Complete Remission (CR)
|
14 Percentage of participants
Interval 4.0 to 40.0
|
SECONDARY outcome
Timeframe: 1 YearRate of Complete Remission (CR)
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Complete Remission (CR)
|
7 Percentage of participants
Interval 0.0 to 31.0
|
SECONDARY outcome
Timeframe: 6 MonthsCumulative Incidence of Non-Relapse Mortality (NRM)
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Non-Relapse Mortality (NRM)
|
14 Percentage of participants
Interval 2.0 to 38.0
|
SECONDARY outcome
Timeframe: 1 YearCumulative Incidence of Non-Relapse Mortality (NRM)
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Non-Relapse Mortality (NRM)
|
14 Percentage of participants
Interval 2.0 to 38.0
|
SECONDARY outcome
Timeframe: 1 YearBest response until next line of treatment, death, or last follow up, whichever occurs sooner
Outcome measures
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 Participants
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Best Response
|
14 Percentage of participants
Interval 2.0 to 38.0
|
Adverse Events
Decitabine + Ruxolitinib + DLI
Serious events: 3 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 participants at risk
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
2/14 • Number of events 11 • 1 year
|
|
Blood and lymphatic system disorders
Lung infection
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Upper gastrointestinal
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Alanine aminotransferase
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Cardiac disorders
Blood and lymphatic system
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Cardiac disorders
Upper gastrointestinal
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Cardiac disorders
Alanine aminotransferase
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Febrile neutropenia
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Blood and lymphatic system
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Neoplasms benign, malignant and
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
General disorders
Sepsis
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
General disorders
Infections and infestations - Other,
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
Tooth infection
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
Infections and infestations - Other,
|
14.3%
2/14 • Number of events 7 • 1 year
|
|
Infections and infestations
Intracranial hemorrhage
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
INR increased
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
Gastrointestinal disorders - Other,
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
Bacteremia
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
Injury, poisoning and procedural
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
Alanine aminotransferase
|
7.1%
1/14 • Number of events 3 • 1 year
|
|
Infections and infestations
Neoplasms benign, malignant and
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Investigations
Encephalopathy
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Investigations
Fatigue
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Investigations
General disorders and administration
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Investigations
Pericardial effusion
|
7.1%
1/14 • Number of events 3 • 1 year
|
|
Investigations
Syncope
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypertension
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Nervous system disorders
Febrile neutropenia
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Nervous system disorders
Sepsis
|
7.1%
1/14 • Number of events 3 • 1 year
|
|
Vascular disorders
Infections and infestations - Other,
|
7.1%
1/14 • Number of events 2 • 1 year
|
Other adverse events
| Measure |
Decitabine + Ruxolitinib + DLI
n=14 participants at risk
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to \>100 x 10\^9/L.
Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
|
|---|---|
|
Infections and infestations
Bacteremia
|
21.4%
3/14 • Number of events 3 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
21.4%
3/14 • Number of events 3 • 1 year
|
|
Infections and infestations
Lung infection
|
21.4%
3/14 • Number of events 3 • 1 year
|
|
Infections and infestations
Sepsis
|
21.4%
3/14 • Number of events 3 • 1 year
|
|
Infections and infestations
Hepatic infection
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Investigations
Neutrophil count decreased
|
57.1%
8/14 • Number of events 10 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14 • Number of events 5 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
2/14 • Number of events 3 • 1 year
|
|
Investigations
INR increased
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Investigations
White blood cell decreased
|
7.1%
1/14 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
57.1%
8/14 • Number of events 11 • 1 year
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
7.1%
1/14 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Typhlitis
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
General disorders
Disease progression
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
General disorders
Fever
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Nervous system disorders
Intracranial hemorrhage
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Cardiac disorders
Hepatobiliary disorders
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Cardiac disorders
Hepatic failure
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • 1 year
|
Additional Information
Mark Juckett , MD
University of Minnesota, Masonic Cancer Center
Phone: 612-676-4200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place