Trial Outcomes & Findings for Daratumumab and Donor Lymphocyte Infusion in Treating Participants With Relapsed Acute Myeloid Leukemia After Stem Cell Transplant (NCT NCT03537599)

NCT ID: NCT03537599

Last Updated: 2025-05-21

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: Up to 6 months
• Results posted on: 2025-05-21

Participant Flow

Due to low enrollment dose levels were not increased during the study

Participant milestones

Measure	Cohort I (High Risk AML) Participants receive daratumumab intravenously once a week for 8 weeks and donor lymphocyte infusion in weeks 3 or 4 in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV Donor Lymphocyte Infusion: Given via infusion Laboratory Biomarker Analysis: Correlative studies	Cohort 2 (AML/MDS-relapsed After Allo-HSCT) Participants receive daratumumab intravenously once a week for 8 weeks and donor lymphocyte infusion in weeks 3 or 4 in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV Donor Lymphocyte Infusion: Given via infusion Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	2	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Cohort I (High Risk AML) Participants receive daratumumab intravenously once a week for 8 weeks and donor lymphocyte infusion in weeks 3 or 4 in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV Donor Lymphocyte Infusion: Given via infusion Laboratory Biomarker Analysis: Correlative studies	Cohort 2 (AML/MDS-relapsed After Allo-HSCT) Participants receive daratumumab intravenously once a week for 8 weeks and donor lymphocyte infusion in weeks 3 or 4 in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV Donor Lymphocyte Infusion: Given via infusion Laboratory Biomarker Analysis: Correlative studies
Overall Study Disease Progression	2	1
Overall Study Death	0	1

Baseline Characteristics

Daratumumab and Donor Lymphocyte Infusion in Treating Participants With Relapsed Acute Myeloid Leukemia After Stem Cell Transplant

Baseline characteristics by cohort

Measure	Cohort I (High Risk AML) n=2 Participants Participants receive daratumumab intravenously once a week for 8 weeks and donor lymphocyte infusion in weeks 3 or 4 in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV Donor Lymphocyte Infusion: Given via infusion Laboratory Biomarker Analysis: Correlative studies	Cohort 2 (AML/MDS-relapsed After Allo-HSCT) n=2 Participants Participants receive daratumumab intravenously once a week for 8 weeks and donor lymphocyte infusion in weeks 3 or 4 in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV Donor Lymphocyte Infusion: Given via infusion Laboratory Biomarker Analysis: Correlative studies	Total n=4 Participants Total of all reporting groups
Age, Continuous	70 years n=5 Participants	62.5 years n=7 Participants	66.25 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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	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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	2 patients n=5 Participants	2 patients n=7 Participants	4 patients n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: Data was not collected due to participants not reaching time point

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: Data was not collected due to participants not reaching time point

Kaplan-Meier estimates of survival and relapse will be made. Response will be measured using standard criteria. For pre/post-treatment comparisons in the correlative part of the study, a paired t-test will be applied. Two-tailed p values <0.05 will be considered statistically significant in all analyses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6 months

Population: Data was not collected due to participants not reaching time point

Kaplan-Meier estimates of survival and relapse will be made. Response will be measured using standard criteria. For pre/post-treatment comparisons in the correlative part of the study, a paired t-test will be applied. Two-tailed p values <0.05 will be considered statistically significant in all analyses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: Data was not collected due to participants not reaching time point

Kaplan-Meier estimates of survival and relapse will be made. Response will be measured using standard criteria. For pre/post-treatment comparisons in the correlative part of the study, a paired t-test will be applied. Two-tailed p values <0.05 will be considered statistically significant in all analyses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: Data was not collected due to participants not reaching time point

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

CD38 expression on bone marrow is checked prior to transplant. Most patients are in remission prior to transplant. Patients who were initially treated at Ohio State University (OSU) will have banked leukemia samples at the time of diagnosis. Expression of CD38 on samples at diagnosis and prior to transplant by immunohistochemical staining will be performed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

Percentage of lymphocytes in bone marrow pre- and post-treatment with daratumumab will be studied. In addition to percentage, expression of CD38 on lymphocytes will be evaluated by immunohistochemistry (IHC).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

This will be performed on bone marrow samples pre-and post-treatment with Daratumumab at the specified time points.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

This will be performed on bone marrow samples pre-and post-treatment with daratumumab.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

This will be evaluated on bone marrow samples pre-and post-treatment with daratumumab.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

This will be examined for both number and also content (protein, messenger ribonucleic acid [mRNA], and micro RNAs [mIRs]).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

Will be assessed with with stromal cell cultures.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

Using single-nucleotide polymorphisms, relative contributions from donor vs. recipient in sorted CD3+ and CD33+ cells will be measured and expressed as a percentage.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

Dr.Gerard Lozanski has developed a panel called the Immunome to study reconstitution of T cells, NK cells and B cells post-transplant. Specific information regarding stages of activation of T cells is also available from this panel.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

This will be performed on bone marrow samples pre-and post-treatment with daratumumab.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

This will be performed on bone marrow samples pre-and post-treatment with daratumumab.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months

Population: Not sufficient number of patients accrued to report on outcomes

This will be measured at relapse, pre and post daratumumab treatment. Exosomes from bone marrow will be examined at these serial times for both number and also content (protein, messenger ribonucleic acid [mRNA], and micro RNA [mIRs]).

Outcome measures

Outcome data not reported

Adverse Events

Cohort I (High Risk AML)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2 (AML/MDS-relapsed After Allo-HSCT)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cohort I (High Risk AML) n=2 participants at risk Participants receive daratumumab intravenously once a week for 8 weeks and donor lymphocyte infusion in weeks 3 or 4 in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV Donor Lymphocyte Infusion: Given via infusion Laboratory Biomarker Analysis: Correlative studies	Cohort 2 (AML/MDS-relapsed After Allo-HSCT) n=2 participants at risk Participants receive daratumumab intravenously once a week for 8 weeks and donor lymphocyte infusion in weeks 3 or 4 in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV Donor Lymphocyte Infusion: Given via infusion Laboratory Biomarker Analysis: Correlative studies
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Blood and lymphatic system disorders Anemia	100.0% 2/2 • Number of events 4 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	100.0% 2/2 • Number of events 4 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Metabolism and nutrition disorders Anorexia	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Injury, poisoning and procedural complications Bruising	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	100.0% 2/2 • Number of events 2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Gastrointestinal disorders Constipation	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Gastrointestinal disorders Diarrhea	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	100.0% 2/2 • Number of events 2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Nervous system disorders Dysgeusia	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Ear and labyrinth disorders Bloody Ear	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 3 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
General disorders Fatigue	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	100.0% 2/2 • Number of events 6 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
General disorders Fever	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 3 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Nervous system disorders Headache	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Metabolism and nutrition disorders Hyperglycemia	100.0% 2/2 • Number of events 9 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 3 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 1/2 • Number of events 2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 3 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 4 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 3 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Vascular disorders Hypotension	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Investigations INR increased	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Immune system disorders Infusion related reaction	100.0% 2/2 • Number of events 2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	100.0% 2/2 • Number of events 2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Investigations Lymphocyte count decreased	100.0% 2/2 • Number of events 6 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	100.0% 2/2 • Number of events 3 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
General disorders Multi-organ failure	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Gastrointestinal disorders Nausea	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Investigations Neutrophil count decreased	100.0% 2/2 • Number of events 7 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	100.0% 2/2 • Number of events 9 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Investigations Platelet count decreased	100.0% 2/2 • Number of events 6 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	100.0% 2/2 • Number of events 7 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Infections and infestations Sepsis	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Nervous system disorders Somnolence	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Renal and urinary disorders Urinary frequency	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Gastrointestinal disorders Vomiting	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Blood and lymphatic system disorders White blood cell decreased	100.0% 2/2 • Number of events 3 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	100.0% 2/2 • Number of events 9 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Injury, poisoning and procedural complications Fall	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Investigations Creatinine increased	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Gastrointestinal disorders Gastroesophageal reflux disease	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Vascular disorders Hypertension	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Endocrine disorders Hypothyroidism	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Metabolism and nutrition disorders Obesity	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Nervous system disorders Peripheral motor neuropathy	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Blood and lymphatic system disorders Vitamin B12 deficiency	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Blood and lymphatic system disorders Folate Deficiency	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Eye disorders Blurred vision	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Investigations CD4 lymphocytes decreased	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/2 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.	50.0% 1/2 • Number of events 1 • Adverse events were collected and monitored from the start of the study until study completion up to an average of 4 months. The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events.

Additional Information

Dr. Sumithira Vasu

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-9869

Email: Sumithira.Vasu@osumc.edu

Results disclosure agreements

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