Trial Outcomes & Findings for Decitabine Followed by Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory AML and MDS (NCT NCT01607645)

NCT ID: NCT01607645

Last Updated: 2017-03-31

Results Overview

Morphologic complete remission (CR): Absolute Neutrophil Count (ANC)≥1,000/uL, platelet count ≥100,000/uL, \<5% Bone Marrow (BM) blasts, no Auer rods (cytoplasmic inclusions which result from an abnormal fusion of the primary (azurophilic) granules), no morphologic dysplasia, and no evidence of extramedullary disease

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: Participants were monitored up until the point when they went off study following completion of the treatment (3 months)
• Results posted on: 2017-03-31

Participant Flow

Participant were enrolled between 8/23/12 and 5/16/13 at the FHCRC

Participant milestones

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decitabine Followed by Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory AML and MDS

Baseline characteristics by cohort

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Total n=7 Participants Total of all reporting groups
Age, Continuous	50.75 years STANDARD_DEVIATION 16.46 • n=5 Participants	34.67 years STANDARD_DEVIATION 13.01 • n=7 Participants	43.86 years STANDARD_DEVIATION 16.31 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=7 Participants	1 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	4 Participants n=5 Participants	2 Participants n=7 Participants	6 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	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were monitored up until the point when they went off study following completion of the treatment (3 months)

Morphologic complete remission (CR): Absolute Neutrophil Count (ANC)≥1,000/uL, platelet count ≥100,000/uL, <5% Bone Marrow (BM) blasts, no Auer rods (cytoplasmic inclusions which result from an abnormal fusion of the primary (azurophilic) granules), no morphologic dysplasia, and no evidence of extramedullary disease

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Number of Participants Who Achieved Morphologic CR CR	2 participants	0 participants
Number of Participants Who Achieved Morphologic CR CRi-MRD (Minimal Residual Disease)	1 participants	0 participants
Number of Participants Who Achieved Morphologic CR Refractory	1 participants	3 participants

SECONDARY outcome

Timeframe: Assessed for up to 90 days

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Resistant Disease Defined as Patient Survives at Least 14 Days After Completion of the Last Dose of Induction or Re-induction But Has Persistent Leukemia in Peripheral Blood (PB) or BM	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Assessed for up to 5 years

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Cytogenetic Response Defined as no Detectable Cytogenetic Abnormality in a Subsequent BM Specimen After Induction or Re-induction	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed for up to 5 years

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
CRMRD- Defined as Morphologic CR Without Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed for up to 5 years

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
CRi Defined as Meeting All Criteria for a Morphologic CR But ANC Remains Less Than 1,000/μL and/or Platelet Count Less Than 100,000/μL	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed for up to 5 years

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
CRMRD+ Defined as a Morphologic CR But With Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed for up to 5 years

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
CRiMRD+ Defined as Meeting All Criteria for a CRi But With Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed for up to Day 30

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
TRM With Each Course of Decitabine-priming, Idarubicin, and Cytarabine	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed for up to 3 months after completion study treatment

Population: We have analyzed 4 and 3 patients in each arm, respectively. One patient in each of the arms completed 2 cycles of therapy. The numbers provided in the Outcome Measure Data Table in Frequency and Severity of Grade 3, 4, and 5 Toxicities are the numbers of patients with each specified event.

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0 CYCLE 1 : Infection Grade 3	2 Participants	0 Participants
Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0 CYCLE 1 : Infection Grade 4	0 Participants	1 Participants
Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0 CYCLE 1 : Hepatobiliary Grade 3	0 Participants	1 Participants
Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0 CYCLE 1 : Blood and Lymphatic Grade 3	3 Participants	1 Participants
Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0 CYCLE 1 : Gastrointenstinal Grade 3	0 Participants	0 Participants
Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0 CYCLE 2 : Infection Grade 3	0 Participants	0 Participants
Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0 CYCLE 2 : Infection Grade 4	0 Participants	0 Participants
Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0 CYCLE 2 : Hepatobiliary Grade 3	0 Participants	0 Participants
Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0 CYCLE 2 : Blood and Lymphatic Grade 3	1 Participants	0 Participants
Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0 CYCLE 2 : Gastrointenstinal Grade 3	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed for up to 45 days

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Severe Prolonged Aplasia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed for up to 5 years

Population: No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Duration of Severe Neutropenia Defined as an ANC Less Than 500	65 days Interval 25.0 to 106.0	—

SECONDARY outcome

Timeframe: Assessed for up to 5 years

Population: No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Duration of Moderate Neutropenia Defined as an ANC Less Than 1000	67 days Interval 30.0 to 106.0	—

SECONDARY outcome

Timeframe: Assessed for up to 5 years

Population: No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.

Outcome measures

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=3 Participants Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Duration of Thrombocytopenia Defined as Platelet Count Less Than 100,000	51 days Interval 18.0 to 103.0	—

Adverse Events

Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 participants at risk Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 participants at risk Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Infections and infestations Grade 4 Infection	0.00% 0/4 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	33.3% 1/3 • Number of events 1 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.

Other adverse events

Measure	Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine) n=4 participants at risk Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV	Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine) n=3 participants at risk Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I. decitabine: Given IV idarubicin: Given IV cytarabine: Given IV
Blood and lymphatic system disorders Febrile Neutropenia	50.0% 2/4 • Number of events 2 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	66.7% 2/3 • Number of events 2 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.
Gastrointestinal disorders Abdominal Pain	25.0% 1/4 • Number of events 1 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	0.00% 0/3 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.
Gastrointestinal disorders Hemorrhoids	50.0% 2/4 • Number of events 2 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	0.00% 0/3 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 1 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	0.00% 0/3 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.
Hepatobiliary disorders Hyperbilirubinemia	25.0% 1/4 • Number of events 1 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	66.7% 2/3 • Number of events 2 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.
Infections and infestations Infection	50.0% 2/4 • Number of events 5 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	0.00% 0/3 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.
Skin and subcutaneous tissue disorders Joint pain	0.00% 0/4 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	33.3% 1/3 • Number of events 1 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.
Skin and subcutaneous tissue disorders Back Pain	25.0% 1/4 • Number of events 1 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	0.00% 0/3 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.
Reproductive system and breast disorders Menorrhagia	25.0% 1/4 • Number of events 1 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	0.00% 0/3 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.
Vascular disorders Venous thrombosis	25.0% 1/4 • Number of events 1 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.	0.00% 0/3 • The Adverse Events were assessed while the participants were receiving study specific treatment for up to 3 months after the start of the treatment.

Additional Information

Derek L. Stirewalt

FHCRC

Phone: 2066675386

Email: dstirewa@fhcrc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place