Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02604511
Collaborator
Pharmacyclics LLC. (Industry)
31
Enrollment
2
Locations
1
Arm
85
Anticipated Duration (Months)
15.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research study is studying a drug called ibrutinib as a possible treatment for untreated Waldenstrom's Macroglobulinemia (WM).

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The FDA (the U.S. Food and Drug Administration) has approved ibrutinib as a form of treatment for the patient specific disease.

Ibrutinib has been under investigation in research studies in participants with recurrent B-cell lymphoma, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and prolymphocytic leukemia, and WM. In a study of ibrutinib in relapsed/refractory WM patients, response rates were high and the treatment was well tolerated.

The prior studies suggest that ibrutinib may be a useful treatment strategy for untreated WM patients. This study will test the safety and efficacy of ibrutinib as an option for untreated WM patients. The study will also conduct genomic sequencing of malignant WM cells before the start of treatment, and 6, 12, 24, 36 and 48 months afterwards. Genomic sequencing is the analysis of the entire DNA structure from tumor and normal cells. The purpose of this sequencing is to study which genetic changes effect how ibrutinib works. The results of these studies could also help in better understanding the course of WM disease, and be applicable to the development of other effective drug treatments.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Ibrutinib

This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration.

Drug: Ibrutinib
Other Names:
  • Imbruvica
  • PCI-32765
  • Outcome Measures

    Primary Outcome Measures

    1. Major Response Rate [4 years]

      To asses the proportion of participants with a PR (50% reduction or more in serum IgM) or better.

    2. Best Overall Response Rate [4 years]

      To asses the proportion of participants with an MR (25% reduction or more in serum IgM) or better.

    Secondary Outcome Measures

    1. Duration of Response [4 years]

      The amount of time between attainment of at least a minor response and disease progression.

    Other Outcome Measures

    1. Time to Response [4 years]

      The amount of time between starting treatment and attaining at least a minor response to therapy

    2. Progression Free Survival [4 years]

      The number of participants who have not experienced disease progression 4 years after therapy initiation

    3. Overall Survival [4 years]

      The number of participants who are still living 4 years after initiation of ibrutinib

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia (Kyle et al, 2003).

    • Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of ≥ 2 times the upper limit of normal is required.

    • Age ≥ 18 years.

    • ECOG performance status ≤2 (see Appendix A.).

    • Participants must have normal organ and marrow function as defined below:

    • Absolute neutrophil count ≥ 1,000/μL

    • Platelets ≥ 50,000/μL

    • Hemoglobin ≥ 8 g/dL

    • Total bilirubin ≤ 2.0. mg/dL or < 2.5 mg/dL if attributable to hepatic infiltration by neoplastic disease or Gilbert's syndrome.

    • AST (SGOT) and ALT (SGPT) ≤ 2.5 X institutional upper limit of normal

    • Estimated Creatinine Clearance ≥30ml/min

    • Not on any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skin.

    • Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) while participating in the study; and 2) for at least 28 days after discontinuation from the study. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. FCBP must be referred to a qualified provider of contraceptive methods if needed.

    • Able to adhere to the study visit schedule and other protocol requirements.

    • Ability to understand and the willingness to sign a written informed consent document.

    • Both men and women of all races and ethnic groups are eligible for this trial.

    Exclusion Criteria:
    • Prior systemic therapy for WM

    • Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form.

    • Concurrent use of any other anti-cancer treatments or any other investigational agents.

    • Concomitant use of warfarin or other Vitamin K antagonists.

    • Concomitant treatment with strong CYP3A4/5 inhibitor.

    • Any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

    • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion could interfere with the absorption or metabolism of ibrutinib.

    • Known CNS lymphoma.

    • Concomitant use of medication known to cause QT prolongation.

    • Currently active, clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction, unstable angina or acute coronary syndrome within 6 months of screening.

    • Malabsorption, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.

    • Known history of Human Immunodeficiency Virus (HIV), active infection with Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV). Subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.

    • Lactating or pregnant women.

    • Inability to swallow capsules.

    • History of non-compliance to medical regimens.

    • Unwilling or unable to comply with the protocol.

    • Major surgery within 4 weeks of first dose of study drug.

    • No active infections requiring systemic therapy.

    • Known bleeding disorders with the exception of acquired Von Willebrand Disorder suspected on the basis of WM.

    • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Massacusetts General HospitalBostonMassachusettsUnited States02114
    2Dana-Farber Cancer InstituteBostonMassachusettsUnited States02215

    Sponsors and Collaborators

    • Dana-Farber Cancer Institute
    • Pharmacyclics LLC.

    Investigators

    • Principal Investigator: Steven P Treon, MD, PhD, Dana-Farber Cancer Institute

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Steven P. Treon, MD, PhD, Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT02604511
    Other Study ID Numbers:
    • 15-359
    First Posted:
    Nov 13, 2015
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Dec 1, 2021
    Keywords provided by Steven P. Treon, MD, PhD, Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleIbrutinib
    Arm/Group DescriptionThis is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    Period Title: Overall Study
    STARTED31
    COMPLETED19
    NOT COMPLETED12

    Baseline Characteristics

    Arm/Group TitleIbrutinib
    Arm/Group DescriptionThis is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    Overall Participants31
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    11
    35.5%
    >=65 years
    20
    64.5%
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    67
    Sex: Female, Male (Count of Participants)
    Female
    23
    74.2%
    Male
    8
    25.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    2
    6.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    28
    90.3%
    More than one race
    0
    0%
    Unknown or Not Reported
    1
    3.2%
    Region of Enrollment (participants) [Number]
    United States
    31
    100%

    Outcome Measures

    1. Primary Outcome
    TitleMajor Response Rate
    DescriptionTo asses the proportion of participants with a PR (50% reduction or more in serum IgM) or better.
    Time Frame4 years

    Outcome Measure Data

    Analysis Population Description
    All participants except one participant determined to be ineligible
    Arm/Group TitleIbrutinib
    Arm/Group DescriptionThis is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    Measure Participants30
    Count of Participants [Participants]
    26
    83.9%
    2. Primary Outcome
    TitleBest Overall Response Rate
    DescriptionTo asses the proportion of participants with an MR (25% reduction or more in serum IgM) or better.
    Time Frame4 years

    Outcome Measure Data

    Analysis Population Description
    All participants except one participant determined to be ineligible
    Arm/Group TitleIbrutinib
    Arm/Group DescriptionThis is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    Measure Participants30
    Count of Participants [Participants]
    30
    96.8%
    3. Secondary Outcome
    TitleDuration of Response
    DescriptionThe amount of time between attainment of at least a minor response and disease progression.
    Time Frame4 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Other Pre-specified Outcome
    TitleTime to Response
    DescriptionThe amount of time between starting treatment and attaining at least a minor response to therapy
    Time Frame4 years

    Outcome Measure Data

    Analysis Population Description
    All participants except one determined to be ineligible
    Arm/Group TitleIbrutinib
    Arm/Group DescriptionThis is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    Measure Participants30
    Median (95% Confidence Interval) [months]
    0.9
    5. Other Pre-specified Outcome
    TitleProgression Free Survival
    DescriptionThe number of participants who have not experienced disease progression 4 years after therapy initiation
    Time Frame4 years

    Outcome Measure Data

    Analysis Population Description
    All participants except for one determined to be ineligible
    Arm/Group TitleIbrutinib
    Arm/Group DescriptionThis is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    Measure Participants30
    Count of Participants [Participants]
    24
    77.4%
    6. Other Pre-specified Outcome
    TitleOverall Survival
    DescriptionThe number of participants who are still living 4 years after initiation of ibrutinib
    Time Frame4 years

    Outcome Measure Data

    Analysis Population Description
    All participants except one who was determined to be ineligible
    Arm/Group TitleIbrutinib
    Arm/Group DescriptionThis is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    Measure Participants30
    Count of Participants [Participants]
    30
    96.8%

    Adverse Events

    Time FrameAdverse events were collected after ibrutinib initiation, through 30 days of last dose of ibrutinib (e.g. 49 months)
    Adverse Event Reporting Description
    Arm/Group TitleIbrutinib
    Arm/Group DescriptionThis is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    All Cause Mortality
    Ibrutinib
    Affected / at Risk (%)# Events
    Total0/31 (0%)
    Serious Adverse Events
    Ibrutinib
    Affected / at Risk (%)# Events
    Total15/31 (48.4%)
    Cardiac disorders
    Atrial fibrillation2/31 (6.5%) 2
    Ventricular fibrillation1/31 (3.2%) 1
    Gastrointestinal disorders
    Rectal bleeding1/31 (3.2%) 1
    General disorders
    Non-Cardiac Chest pain1/31 (3.2%) 1
    Fever1/31 (3.2%) 1
    Drug-induced hepatitis1/31 (3.2%) 1
    Infections and infestations
    Colitis1/31 (3.2%) 1
    Pneumonia1/31 (3.2%) 1
    Prostatitis1/31 (3.2%) 1
    Injury, poisoning and procedural complications
    Head trauma1/31 (3.2%) 1
    Hip fracture1/31 (3.2%) 1
    Investigations
    AST elevation2/31 (6.5%) 2
    ALT elevation2/31 (6.5%) 2
    Metabolism and nutrition disorders
    Diabetic ketoacidosis1/31 (3.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer1/31 (3.2%) 1
    Esophageal cancer1/31 (3.2%) 1
    Nervous system disorders
    Stroke1/31 (3.2%) 1
    Psychiatric disorders
    Mania1/31 (3.2%) 1
    Renal and urinary disorders
    Kidney infection1/31 (3.2%) 1
    Kidney dysfunction1/31 (3.2%) 1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion1/31 (3.2%) 1
    Vascular disorders
    Hematoma1/31 (3.2%) 1
    Other (Not Including Serious) Adverse Events
    Ibrutinib
    Affected / at Risk (%)# Events
    Total31/31 (100%)
    Blood and lymphatic system disorders
    Anemia7/31 (22.6%) 7
    Coagulopathy1/31 (3.2%) 1
    Ecchymosis1/31 (3.2%) 1
    Leukocytosis1/31 (3.2%) 1
    Cardiac disorders
    Atrial fibrillation5/31 (16.1%) 5
    Bradycardia1/31 (3.2%) 1
    Palpitations5/31 (16.1%) 5
    Pericarditis1/31 (3.2%) 1
    Sinus bradycardia2/31 (6.5%) 2
    Sinus tachycardia2/31 (6.5%) 2
    Ear and labyrinth disorders
    Hearing impaired1/31 (3.2%) 1
    Tinnitus2/31 (6.5%) 2
    Vertigo2/31 (6.5%) 2
    Endocrine disorders
    Hypothyroidism1/31 (3.2%) 1
    Eye disorders
    Blurred vision3/31 (9.7%) 3
    Cataract2/31 (6.5%) 2
    Conjunctivitis1/31 (3.2%) 1
    Dry eye3/31 (9.7%) 3
    Eye pain1/31 (3.2%) 1
    Floaters1/31 (3.2%) 1
    Watering eyes1/31 (3.2%) 1
    Gastrointestinal disorders
    Abdominal distension1/31 (3.2%) 1
    Abdominal pain1/31 (3.2%) 1
    Anal hemorrhage1/31 (3.2%) 1
    Bloating3/31 (9.7%) 3
    Constipation7/31 (22.6%) 7
    Diarrhea24/31 (77.4%) 24
    Dry mouth2/31 (6.5%) 2
    Dyspepsia2/31 (6.5%) 2
    Dysphagia5/31 (16.1%) 5
    Eructation2/31 (6.5%) 2
    Flatulence2/31 (6.5%) 2
    Gastroesophageal reflux disease8/31 (25.8%) 8
    Gastrointestinal pain1/31 (3.2%) 1
    Melena2/31 (6.5%) 2
    Mucositis oral11/31 (35.5%) 11
    Nausea11/31 (35.5%) 11
    Oral hemorrhage3/31 (9.7%) 3
    Oral pain2/31 (6.5%) 2
    Rectal hemorrhage2/31 (6.5%) 2
    Stomach flu3/31 (9.7%) 3
    Vomiting7/31 (22.6%) 7
    Diverticulitis1/31 (3.2%) 1
    General disorders
    Blood blister1/31 (3.2%) 1
    Brain bleed1/31 (3.2%) 1
    Chills10/31 (32.3%) 10
    Dental implant1/31 (3.2%) 1
    Edema face1/31 (3.2%) 1
    Edema limbs9/31 (29%) 9
    Esophageal spasm1/31 (3.2%) 1
    Fatigue22/31 (71%) 22
    Fever7/31 (22.6%) 7
    Flu-like symptoms3/31 (9.7%) 3
    Hernia1/31 (3.2%) 1
    Irritability1/31 (3.2%) 1
    Localized edema1/31 (3.2%) 1
    Malaise1/31 (3.2%) 1
    Non-cardiac chest pain1/31 (3.2%) 1
    Pain4/31 (12.9%) 4
    Poison ivy1/31 (3.2%) 1
    Sunburn1/31 (3.2%) 1
    Teeth grinding1/31 (3.2%) 1
    Varicose veins1/31 (3.2%) 1
    Immune system disorders
    Allergic reaction1/31 (3.2%) 1
    Infections and infestations
    Bronchial infection3/31 (9.7%) 3
    Herpes zoster4/31 (12.9%) 4
    Influenza1/31 (3.2%) 1
    Lung infection2/31 (6.5%) 2
    Lyme disease2/31 (6.5%) 2
    Mucosal infection2/31 (6.5%) 2
    Otitis media1/31 (3.2%) 1
    Papulopustular rash1/31 (3.2%) 1
    Paronychia2/31 (6.5%) 2
    Rectum fungus1/31 (3.2%) 1
    Sinusitis7/31 (22.6%) 7
    Skin infection9/31 (29%) 9
    Soft tissue infection1/31 (3.2%) 1
    Tooth infection1/31 (3.2%) 1
    Upper respiratory infection15/31 (48.4%) 15
    Urinary tract infection4/31 (12.9%) 4
    Injury, poisoning and procedural complications
    Ankle fracture1/31 (3.2%) 1
    Bone marrow procedure hemorrhage1/31 (3.2%) 1
    Bruising13/31 (41.9%) 13
    Calf injury1/31 (3.2%) 1
    Concussion1/31 (3.2%) 1
    Fall6/31 (19.4%) 6
    Foot laceration1/31 (3.2%) 1
    Fracture1/31 (3.2%) 1
    Knee injury2/31 (6.5%) 2
    Spinal fracture1/31 (3.2%) 1
    Wrist fracture1/31 (3.2%) 1
    Investigations
    Alanine aminotransferase increased2/31 (6.5%) 2
    Blood bilirubin increased2/31 (6.5%) 2
    Creatinine increased5/31 (16.1%) 5
    Lymphocyte count decreased1/31 (3.2%) 1
    Neutrophil count decreased3/31 (9.7%) 3
    Platelet count decreased7/31 (22.6%) 7
    Urine output decreased1/31 (3.2%) 1
    Weight loss4/31 (12.9%) 4
    White blood cell decreased1/31 (3.2%) 1
    Metabolism and nutrition disorders
    Anorexia2/31 (6.5%) 2
    Hyperglycemia3/31 (9.7%) 3
    Hyperuricemia1/31 (3.2%) 1
    Hypoglycemia1/31 (3.2%) 1
    Hypokalemia1/31 (3.2%) 1
    Hyponatremia2/31 (6.5%) 2
    Hypophosphatemia1/31 (3.2%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia12/31 (38.7%) 12
    Back pain10/31 (32.3%) 10
    Bone pain2/31 (6.5%) 2
    Flank pain2/31 (6.5%) 2
    Generalized muscle weakness4/31 (12.9%) 4
    Joint effusion2/31 (6.5%) 2
    Knee joint hyperflexion1/31 (3.2%) 1
    Myalgia19/31 (61.3%) 19
    Neck pain2/31 (6.5%) 2
    Osteoporosis1/31 (3.2%) 1
    Pain in extremity1/31 (3.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma6/31 (19.4%) 6
    Melanoma1/31 (3.2%) 1
    Mucoid cyst1/31 (3.2%) 1
    Sebaceous cyst1/31 (3.2%) 1
    Nervous system disorders
    Ataxia1/31 (3.2%) 1
    Carpal tunnel1/31 (3.2%) 1
    Dizziness5/31 (16.1%) 5
    Headache10/31 (32.3%) 10
    Lethargy2/31 (6.5%) 2
    Memory impairment1/31 (3.2%) 1
    Paresthesia1/31 (3.2%) 1
    Peripheral sensory neuropathy6/31 (19.4%) 6
    Presyncope1/31 (3.2%) 1
    Syncope2/31 (6.5%) 2
    Transient ischemic attack1/31 (3.2%) 1
    Tremor3/31 (9.7%) 3
    Vasovagal reaction1/31 (3.2%) 1
    Psychiatric disorders
    Anxiety3/31 (9.7%) 3
    Confusion1/31 (3.2%) 1
    Insomnia2/31 (6.5%) 2
    Renal and urinary disorders
    Hematuria4/31 (12.9%) 4
    Renal calculi2/31 (6.5%) 2
    Urinary frequency1/31 (3.2%) 1
    Urinary tract obstruction2/31 (6.5%) 2
    Urinary tract pain1/31 (3.2%) 1
    Reproductive system and breast disorders
    Irregular menstruation1/31 (3.2%) 1
    Respiratory, thoracic and mediastinal disorders
    Allergic rhinitis2/31 (6.5%) 2
    Cough7/31 (22.6%) 7
    Dyspnea5/31 (16.1%) 5
    Epistaxis8/31 (25.8%) 8
    Hiccups1/31 (3.2%) 1
    Pleuritic pain1/31 (3.2%) 1
    Postnasal drip1/31 (3.2%) 1
    Sore throat5/31 (16.1%) 5
    Wheezing1/31 (3.2%) 1
    Skin and subcutaneous tissue disorders
    Alopecia1/31 (3.2%) 1
    Bee sting1/31 (3.2%) 1
    Dry skin2/31 (6.5%) 2
    Eczematous Rash1/31 (3.2%) 1
    Hyperhidrosis8/31 (25.8%) 8
    Nail loss1/31 (3.2%) 1
    Nail ridging5/31 (16.1%) 5
    Onychoclasis2/31 (6.5%) 2
    Onychoschizia2/31 (6.5%) 2
    Petechiae1/31 (3.2%) 1
    Pruritus3/31 (9.7%) 3
    Purpura1/31 (3.2%) 1
    Rash maculo-papular5/31 (16.1%) 5
    Rash not otherwise specified9/31 (29%) 9
    Rosacea1/31 (3.2%) 1
    Seborrheic dermatitis1/31 (3.2%) 1
    Sensitive skin2/31 (6.5%) 2
    Skin atrophy1/31 (3.2%) 1
    Skin bleeding1/31 (3.2%) 1
    Skin induration1/31 (3.2%) 1
    Skin ulceration3/31 (9.7%) 3
    Urticaria1/31 (3.2%) 1
    Wart1/31 (3.2%) 1
    Surgical and medical procedures
    Tooth extraction2/31 (6.5%) 2
    Vascular disorders
    Hematoma8/31 (25.8%) 8
    Hypertension6/31 (19.4%) 6
    Phlebitis1/31 (3.2%) 1
    Vasculitis1/31 (3.2%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr. Steven Treon
    OrganizationDana-Farber Cancer Institute
    Phone617-632-2681
    Emailsteven_treon@dfci.harvard.edu
    Responsible Party:
    Steven P. Treon, MD, PhD, Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT02604511
    Other Study ID Numbers:
    • 15-359
    First Posted:
    Nov 13, 2015
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Dec 1, 2021