Trial Outcomes & Findings for Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas (NCT NCT01030900)

Last Updated: 2022-10-06

Results Overview

PFS is the time interval from start of treatment to documented evidence of disease progression estimated using a Kaplan Meier curve. Progression was assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas and is defined as ≥50% increase from nadir in the sum of the products of diameters of any previously identified abnormal node for partial response or non-responders. And an appearance of any new lesion during or at the end of therapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Time of progression or death, approximately 10 months

Results posted on

2022-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath Participants will receive 30mg of Alemtuzumab on day 1 of therapy, followed by Rituximab on day 1 and dose-adjusted EPOCH chemotherapy days 1-5, up to six cycles of therapy.
Overall Study STARTED	50
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath Participants will receive 30mg of Alemtuzumab on day 1 of therapy, followed by Rituximab on day 1 and dose-adjusted EPOCH chemotherapy days 1-5, up to six cycles of therapy.
Overall Study Not treated due to congestive heart failure	1
Overall Study Not treated due to rapid disease	1

Baseline Characteristics

Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath n=50 Participants Participants will receive 30mg of Alemtuzumab on day 1 of therapy, followed by Rituximab on day 1 and dose-adjusted EPOCH chemotherapy days 1-5, up to six cycles of therapy.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	43 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 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	3 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	8 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
Histology Grey-Zone	4 Participants n=5 Participants
Histology Hodgkin Lymphoma	16 Participants n=5 Participants
Histology Primary mediastinal B-cell lymphoma (PMBL)	5 Participants n=5 Participants
Histology Diffuse large B-cell lymphoma (DLBCL)	23 Participants n=5 Participants
Histology B-cell lymphoma not otherwise specified (NOS)	2 Participants n=5 Participants
Median Number of Prior Lines of Therapy	2 lines of therapy n=5 Participants

PRIMARY outcome

Timeframe: Time of progression or death, approximately 10 months

Population: 48/50 participants were evaluable for this outcome measure because 2 participants were not treated.

Outcome measures

Outcome measures
Measure	Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath n=48 Participants Participants will receive 30mg of Alemtuzumab on day 1 of therapy, followed by Rituximab on day 1 and dose-adjusted EPOCH chemotherapy days 1-5, up to six cycles of therapy.
Progression Free Survival (PFS)	6.6 months Interval 3.3 to 8.8

PRIMARY outcome

Timeframe: Median overall survival from enrollment to the day of death, approximately 17.9 months

Population: 48/50 participants were evaluable for this outcome measure because 2 participants were not treated.

OS is from enrollment to the day of death estimated using the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath n=48 Participants Participants will receive 30mg of Alemtuzumab on day 1 of therapy, followed by Rituximab on day 1 and dose-adjusted EPOCH chemotherapy days 1-5, up to six cycles of therapy.
Overall Survival (OS)	17.9 months Interval 11.5 to 49.6

SECONDARY outcome

Timeframe: On study and at relapse after study treatment, approximately 10 months

Population: 46/50 participants were evaluable for this outcome measure because 2 participants were not treated, and two participants were not evaluable for response.

Clinical response was assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas. Complete remission is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed is as per complete remission except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Relapsed disease is appearance of any new lesion or increase by ≥50% in the size of the previously involved sites. Stable disease is defined as less than a partial response but not progressive disease. Progression is ≥50% increase from nadir in the SPD of diameters of any previously identified abnormal node for partial response or non-responders; and an appearance of any new lesion during or at the end of therapy.

Outcome measures

Outcome measures
Measure	Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath n=46 Participants Participants will receive 30mg of Alemtuzumab on day 1 of therapy, followed by Rituximab on day 1 and dose-adjusted EPOCH chemotherapy days 1-5, up to six cycles of therapy.
Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC) Complete remission	17 Participants
Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC) Complete response unconfirmed	0 Participants
Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC) Partial response	13 Participants
Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC) Stable disease	2 Participants
Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC) Relapsed disease	0 Participants
Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC) Progressive disease	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 58 months and 18 days.

Population: 2/50 participants were not treated.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath n=48 Participants Participants will receive 30mg of Alemtuzumab on day 1 of therapy, followed by Rituximab on day 1 and dose-adjusted EPOCH chemotherapy days 1-5, up to six cycles of therapy.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	48 Participants

Adverse Events

Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath

Serious events: 27 serious events

Other events: 48 other events

Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure	Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath n=48 participants at risk Participants will receive 30mg of Alemtuzumab on day 1 of therapy, followed by Rituximab on day 1 and dose-adjusted EPOCH chemotherapy days 1-5, up to six cycles of therapy.
Cardiac disorders Atrial fibrillation	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Back pain	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Bone pain	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Dehydration	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Diarrhea	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Dizziness	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.2% 3/48 • Number of events 3 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Blood and lymphatic system disorders Febrile neutropenia	41.7% 20/48 • Number of events 36 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
General disorders Fever	8.3% 4/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Vascular disorders Hypotension	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Infections and infestations - Other, E.coli	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Infections and infestations - Other, pseudomonas	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Lung infection	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Myalgia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Nausea	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Sepsis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Vascular disorders Thromboembolic event	6.2% 3/48 • Number of events 3 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Urinary tract infection	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Vomiting	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Wound infection	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.

Other adverse events

Other adverse events
Measure	Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath n=48 participants at risk Participants will receive 30mg of Alemtuzumab on day 1 of therapy, followed by Rituximab on day 1 and dose-adjusted EPOCH chemotherapy days 1-5, up to six cycles of therapy.
Gastrointestinal disorders Abdominal pain	10.4% 5/48 • Number of events 8 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Activated partial thromboplastin time prolonged	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Renal and urinary disorders Acute kidney injury	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Alanine aminotransferase increased	22.9% 11/48 • Number of events 20 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Alkaline phosphatase increased	8.3% 4/48 • Number of events 6 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Immune system disorders Allergic reaction	8.3% 4/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Alopecia	35.4% 17/48 • Number of events 17 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Anal pain	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Blood and lymphatic system disorders Anemia	89.6% 43/48 • Number of events 130 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Anorectal infection	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Anorexia	14.6% 7/48 • Number of events 8 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Psychiatric disorders Anxiety	10.4% 5/48 • Number of events 5 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Aspartate aminotransferase increased	22.9% 11/48 • Number of events 16 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Cardiac disorders Atrial fibrillation	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Back pain	8.3% 4/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Bladder infection	8.3% 4/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Renal and urinary disorders Bladder spasm	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, Amylase Ser	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, Partial thromboplastin time (PTT)	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Blood bilirubin increased	6.2% 3/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Eye disorders Blurred vision	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Bone pain	29.2% 14/48 • Number of events 19 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Cluster of differentiation 4 (CD4) lymphocytes decreased	25.0% 12/48 • Number of events 13 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Creatine phosphokinase (CPK) increased	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Cardiac disorders Sinus Tachycardia	20.8% 10/48 • Number of events 12 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Cardiac disorders Cardiac disorders - Other, orthostasis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Cardiac disorders Cardiac troponin I increased	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Catheter related infection	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Cardiac disorders Chest pain - cardiac	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Chest wall pain	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
General disorders Chills	37.5% 18/48 • Number of events 23 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Constipation	37.5% 18/48 • Number of events 20 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 6/48 • Number of events 7 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Creatinine increased	8.3% 4/48 • Number of events 5 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Renal and urinary disorders Cystitis noninfective	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Immune system disorders Cytokine release syndrome	10.4% 5/48 • Number of events 6 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Dehydration	14.6% 7/48 • Number of events 8 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Psychiatric disorders Depression	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Diarrhea	37.5% 18/48 • Number of events 26 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Dizziness	18.8% 9/48 • Number of events 12 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Eye disorders Dry eye	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Dry skin	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Dysgeusia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Dysphagia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Dysphasia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 8/48 • Number of events 9 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Ear and labyrinth disorders Ear pain	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
General disorders Edema limbs	10.4% 5/48 • Number of events 5 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Enterocolitis infectious	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Erythema multiforme	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Esophagitis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Injury, poisoning and procedural complications Fall	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
General disorders Fatigue	50.0% 24/48 • Number of events 27 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Blood and lymphatic system disorders Febrile neutropenia	41.7% 20/48 • Number of events 37 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
General disorders Fever	39.6% 19/48 • Number of events 21 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
General disorders Flu like symptoms	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Gastroesophageal reflux disease	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Headache	31.2% 15/48 • Number of events 20 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Ear and labyrinth disorders Hearing impaired	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Renal and urinary disorders Hematuria	8.3% 4/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Hiccups	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Hoarseness	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hypercalcemia	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hyperglycemia	10.4% 5/48 • Number of events 5 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hyperkalemia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hypermagnesemia	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hypernatremia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Vascular disorders Hypertension	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hyperuricemia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hypoalbuminemia	64.6% 31/48 • Number of events 48 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hypocalcemia	16.7% 8/48 • Number of events 10 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hypoglycemia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hypokalemia	20.8% 10/48 • Number of events 12 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hypomagnesemia	16.7% 8/48 • Number of events 12 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hyponatremia	16.7% 8/48 • Number of events 9 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Metabolism and nutrition disorders Hypophosphatemia	35.4% 17/48 • Number of events 29 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Vascular disorders Hypotension	18.8% 9/48 • Number of events 12 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Ileal obstruction	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Infections and infestations - Other, C. Diff	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Infections and infestations - Other, cytomegalovirus (CMV)	8.3% 4/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Infections and infestations - Other, herpes simplex virus (HSV)	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Infections and infestations - Other, Klebsiella pan S	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Infections and infestations - Other, Wound	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Infections and infestations - Other, specify	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
General disorders Infusion related reaction	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Psychiatric disorders Insomnia	10.4% 5/48 • Number of events 5 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	6.2% 3/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Cardiac disorders Left ventricular systolic dysfunction	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Lung infection	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Lymphocyte count decreased	93.8% 45/48 • Number of events 120 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
General disorders Malaise	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Memory impairment	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Mucosal infection	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Mucositis oral	43.8% 21/48 • Number of events 32 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Muscle weakness trunk	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Myalgia	10.4% 5/48 • Number of events 5 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Nausea	39.6% 19/48 • Number of events 30 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Neck pain	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Nervous system disorders - Other, Autonomic Neuropathy	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Nervous system disorders - Other, recurrent laryngeal nerve palsy	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Nervous system disorders - Other, sensory	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Neuralgia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Neutrophil count decreased	89.6% 43/48 • Number of events 137 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Oral pain	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
General disorders Pain	16.7% 8/48 • Number of events 9 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Musculoskeletal and connective tissue disorders Pain in extremity	18.8% 9/48 • Number of events 17 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Cardiac disorders Palpitations	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Papulopustular rash	6.2% 3/48 • Number of events 3 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Reproductive system and breast disorders Pelvic pain	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Peripheral motor neuropathy	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Peripheral sensory neuropathy	41.7% 20/48 • Number of events 22 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Pharyngitis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Platelet count decreased	91.7% 44/48 • Number of events 140 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Postnasal drip	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Injury, poisoning and procedural complications Postoperative hemorrhage	4.2% 2/48 • Number of events 3 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Productive cough	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Pruritus	12.5% 6/48 • Number of events 6 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Purpura	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Rash acneiform	8.3% 4/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.3% 4/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Rash pustular	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Rectal hemorrhage	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Rectal mucositis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Rectal pain	4.2% 2/48 • Number of events 3 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Sepsis	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Cardiac disorders Sinus bradycardia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Cardiac disorders Cardiac disorders - Other, tachycardia	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Sinusitis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Skin infection	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Sore throat	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Nervous system disorders Syncope	4.2% 2/48 • Number of events 3 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Vascular disorders Thromboembolic event	20.8% 10/48 • Number of events 10 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Ear and labyrinth disorders Tinnitus	2.1% 1/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Tooth infection	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Toothache	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Respiratory, thoracic and mediastinal disorders Tracheal mucositis	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Upper respiratory infection	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Renal and urinary disorders Urinary frequency	8.3% 4/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Infections and infestations Urinary tract infection	16.7% 8/48 • Number of events 10 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Renal and urinary disorders Urinary tract pain	8.3% 4/48 • Number of events 4 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Renal and urinary disorders Urinary urgency	2.1% 1/48 • Number of events 1 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Skin and subcutaneous tissue disorders Urticaria	16.7% 8/48 • Number of events 10 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Gastrointestinal disorders Vomiting	20.8% 10/48 • Number of events 13 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Eye disorders Watering eyes	4.2% 2/48 • Number of events 2 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations Weight loss	6.2% 3/48 • Number of events 3 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.
Investigations White blood cell decreased	97.9% 47/48 • Number of events 167 • Date treatment consent signed to date off study, approximately 58 months and 18 days. 2/50 participants were not treated.

Additional Information

Dr. Wyndham Wilson

National Cancer Institute

Phone: (240) 760-6092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place