Trial Outcomes & Findings for BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma (NCT NCT03264131)

Last Updated: 2025-02-10

Results Overview

The response was assessed based on the International Workshop to standardize response criteria for malignant lymphomas (i.e., Lugano Criteria per Cheson, et al. J Clin Oncol. 2014;32(27):3059-68; Complete Response: Positron emission tomography (PET): Complete metabolic response Computerized tomography (CT): Target must regress to ≤ 1.5 cm in the largest transverse diameter (LDi) or no extra lymphatic sites of disease. Partial Response: PET: reduced uptake compared with baseline, and CT: ≥50% decrease in the sum of the products of diameters (SPD).No Response or Stable Disease: No metabolic response on PET or \< 50% decrease from baseline in SPD of up to 6 dominant, measurable nodes and extra nodal sites on CT. Progressive Disease: PET: Score 4 or 5 with an increase in the intensity of uptake or CT: an individual node/lesion must be abnormal with LDi \> 1.5 cm, increase by ≥ 50% from the cross product of the LDi and shortest axis perpendicular to LDi (SDi).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

18 weeks

Results posted on

2025-02-10

Participant Flow

Participants were enrolled in the study between 10/11/2018 - 06/22/2022 at four cancer centers in the United States.

A total of sixteen eligible participants consented and started to the study.

Participant milestones

Participant milestones
Measure	Open-label, Multicenter, Single-Arm This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death. Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days). CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles. Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles. Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label, Multicenter, Single-Arm n=16 Participants This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death. Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days). CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles. Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles. Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	14 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 weeks

Population: Participants started the study and response assessments were completed.

Outcome measures

Outcome measures
Measure	Open-label, Multicenter, Single-Arm n=16 Participants This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death. Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days). CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles. Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles. Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
Complete Response Rate After 2-6 Cycles of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP) Complete Response	10 Participants
Complete Response Rate After 2-6 Cycles of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP) Partial Response	4 Participants
Complete Response Rate After 2-6 Cycles of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (BV-CHEP) Progressive Disease	2 Participants

Adverse Events

Open-label, Multicenter, Single-Arm

Serious events: 7 serious events

Other events: 9 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Open-label, Multicenter, Single-Arm n=16 participants at risk This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death. Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days). CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles. Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles. Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
Blood and lymphatic system disorders Febrile neutropenia	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Ear and labyrinth disorders Hearing impaired	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Eye disorders Eye pain	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Constipation	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Mucositis oral	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Typhlitis	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Vomiting	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
General disorders Fatigue	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
General disorders Fever	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
General disorders General disorders and administration site conditions - Other, specify	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
General disorders pain	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Infections and infestations Infections and infestations - Other, specify	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Neutrophil count decreased	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Platelet count decreased	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Weight loss	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Musculoskeletal and connective tissue disorders Bone pain	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.

Other adverse events

Other adverse events
Measure	Open-label, Multicenter, Single-Arm n=16 participants at risk This is a single-arm intervention where patients will receive concurrent therapy with BV+CHEP \[(brentuximab vedotin; 1.8 mg/kg IV, on D1 every 21 days) (cyclophosphamide 750 mg/m\^2 on D1; doxorubicin 50 mg/m\^2 on D1, etoposide 100 mg/m\^2 IV infusion on D1-3; prednisone 100 mg orally once daily on D1-5; cycle length every 21 days)\] for 2 to 6 cycles of induction therapy. After 6 cycles of BV + CHEP, responders (CR, PR or SD) who are not eligible for BMT and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV, every 21 days) until disease progression, withdrawal due to toxicity or death. Brentuximab Vedotin: Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days). CHEP: Cyclophosphamide- 750 mg/m\^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles Doxorubicin- 50 mg/m\^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles. Etoposide - 100 mg/m\^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles. Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles.
Blood and lymphatic system disorders Anemia	43.8% 7/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	18.8% 3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Blood and lymphatic system disorders Febrile neutropenia	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Cardiac disorders Sinus tachycardia	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Ear and labyrinth disorders Tinnitus	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Eye disorders Eye disorders - Other, specify	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Abdominal pain	31.2% 5/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Colitis	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Constipation	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Diarrhea	31.2% 5/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Dry mouth	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Dyspepsia	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Dysphagia	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Gastroesophageal reflux disease	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Mucositis oral	37.5% 6/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Nausea	43.8% 7/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Oral pain	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Gastrointestinal disorders Vomiting	18.8% 3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
General disorders Chills	37.5% 6/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
General disorders Edema limbs	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
General disorders Fatigue	25.0% 4/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
General disorders Fever	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
General disorders General disorders and administration site conditions - Other, specify	18.8% 3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Infections and infestations Infections and infestations - Other, specify	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Infections and infestations Upper respiratory infection	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Injury, poisoning and procedural complications Bruising	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Alkaline phosphatase increased	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Aspartate aminotransferase increased	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Carbon monoxide diffusing capacity decreased	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Cholesterol high	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Creatinine increased	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Investigations - Other, specify	25.0% 4/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Lymphocyte count decreased	18.8% 3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Lymphocyte count increased	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Neutrophil count decreased	25.0% 4/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations Platelet count decreased	25.0% 4/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Investigations White blood cell decreased	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Metabolism and nutrition disorders Anorexia	18.8% 3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Metabolism and nutrition disorders Hypercalcemia	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Metabolism and nutrition disorders Hypocalcemia	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Metabolism and nutrition disorders Hypokalemia	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Metabolism and nutrition disorders Hypomagnesemia	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Metabolism and nutrition disorders Hyponatremia	18.8% 3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Metabolism and nutrition disorders Hypophosphatemia	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Musculoskeletal and connective tissue disorders Back pain	25.0% 4/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	18.8% 3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Musculoskeletal and connective tissue disorders Neck pain	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Nervous system disorders Dizziness	31.2% 5/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Nervous system disorders Dysgeusia	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Nervous system disorders Headache	37.5% 6/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Nervous system disorders Paresthesia	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Nervous system disorders Peripheral sensory neuropathy	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Nervous system disorders Radiculitis	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Nervous system disorders Tremor	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Psychiatric disorders Anxiety	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Psychiatric disorders Confusion	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Psychiatric disorders Insomnia	18.8% 3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Renal and urinary disorders Cystitis noninfective	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Respiratory, thoracic and mediastinal disorders Hiccups	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Respiratory, thoracic and mediastinal disorders Sore throat	18.8% 3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Skin and subcutaneous tissue disorders Nail discoloration	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Skin and subcutaneous tissue disorders Nail loss	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	18.8% 3/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Skin and subcutaneous tissue disorders Skin ulceration	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Vascular disorders Hypertension	12.5% 2/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.
Vascular disorders Hypotension	6.2% 1/16 • Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment. (Up to 14 months) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03). All hospitalization was graded as SAE per protocol criteria.

Additional Information

Melahat Garipagaoglu Canter

UNC Lineberger Comprehensive Cancer Center

Phone: 919-962-0000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Study publication should be a joint publication of all sites. A separate site publication is restricted until 24 months after the study completion or study publication.
Publication restrictions are in place

Restriction type: OTHER