Ofatumumab, High Dose Methylprednisolone, Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLL/SLL
Study Details
Study Description
Brief Summary
The main purpose of this study is to see if ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help people with Chronic Lymphocytic Leukemia (CLL) get rid of their CLL for a long period of time. Researchers also want to find out if the combination of ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe and tolerable.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
This is a phase II, single institution, and non-randomized study of patients with untreated CLL/SLL, utilizing a two-stage trial design. The primary endpoint for this trial is the combined complete and partial response rate (at 3 months-the end of cycle 3) to the protocol therapy. We anticipate this trial will have a complete response (CR) and partial response (PR) rate of at least 80%.
A two-stage design is employed for this trial. The null/unacceptable CR+PR response rate is ≤ 60% while the anticipated true response rate to the protocol treatment is at least 80% for each disease cohort. At the first stage, 26 patients will be accrued to the trial. If 15 or fewer of these patients respond, then the trial will be terminated early and the response rate to the protocol treatment will be deemed unacceptable (≤ 60%). Otherwise, if more than 15 patients respond during the first stage, an additional 19 patients will be enrolled to this trial during stage 2 for a total of 45 patients. If 32 or fewer of these 45 patients respond to the protocol treatment at the end of stage 2, no further investigation of the protocol treatment is considered warranted. On the other hand, if more than 32 patients out of the 45 enrolled patients respond, the protocol treatment will be considered promising. If the true response rate is ≤ 60%, the probability of ending the trial at stage 1 is 0.48. If, however, the true response rate is at least 80%, then the probability of ending the trial at stage 1 is only 0.01. This two-stage design has an overall alpha level of 0.045 and a power of 0.90.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Immunotherapy Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide |
Drug: High Dose Methylprednisolone (HDMP)
HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
Other Names:
Drug: Ofatumumab
Ofatumumab infusion will be administered immediately after HDMP.
Other Names:
Drug: Lenalidomide
The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Complete Response (CR) [3 Months]
Number of participants with complete response, the disappearance of all signs of cancer in response to treatment.
- Number of Participants With Partial Response (PR) [3 Months]
The primary endpoint for this trial is the combined complete and partial response rate to the protocol therapy at 3 months, which is also the end of Cycle 3. The objective response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution.
Secondary Outcome Measures
- Rate of Progression/Relapse Free Survival (PFS) [Up to 56 months]
Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier.
- Number of Participants With Overall Survival (OS) [36 Months]
Overall survival will be summarized with the Kaplan-Meier curve.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Understand and voluntarily sign an informed consent form
-
Able to adhere to the study visit schedule and other protocol requirements
-
Patients must have histologically or cytologically confirmed CD5+/CD20+ B-Cell chronic lymphocytic leukemia or small lymphocytic lymphoma. The diagnosis of CLL is based upon the National Comprehensive Cancer Network (NCCN) guidelines. Any outside pathology slides used as inclusion criteria for the patient will be reviewed at this institution to confirm the diagnosis. The patient must meet all of the following CLL criteria to participate in this study: absolute lymphocyte count > 5000/μL; CD20+ and CD5+; Bone marrow lymphocytes ≥ 30%; Or previous confirmed diagnosis of CLL/SLL with less than 5000/μl or less than 30% lymphocytes in bone marrow.
-
Patients are eligible if they have stage III or IV disease. Patients with stage 0, I or II disease will be eligible if they have evidence of active disease defined as one or more of the following signs/symptoms: Documented weight loss of ≥ 10% over a 6 month period; Febrile episodes of 38 degrees Celsius (100.5 degrees F) or greater for greater than 2 weeks without evidence of infection; Massive or progressive splenomegaly defined as > 6 cm below the left costal margin; Massive (> 10 cm in longest diameter) or progressive lymphadenopathy.
-
Patient has not received any prior treatment for CLL in the past.
-
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at study entry
-
Laboratory test results within these ranges: Absolute neutrophil count ≥ 1000/mm³; Platelet count ≥ 50,000 /mm³; Renal function assessed by calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula; Total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤ 2.5 x ULN; Alkaline phosphatase <2.5 x ULN
-
Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
-
All study participants must be registered into the mandatory REMS® program, and be willing and able to comply with the requirements of REMS®.
-
Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
-
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin).
Exclusion Criteria:
-
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
-
Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
-
Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
-
Evidence of laboratory Tumor Lysis Syndrome (TLS) by Cairo-Bishop Definition. Patients may be enrolled upon correction of electrolyte abnormalities.
-
Use of any other experimental drug or therapy within 28 days of baseline
-
Known hypersensitivity to thalidomide
-
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
-
Any prior use of lenalidomide
-
Concurrent use of other anti-cancer agents or treatments
-
Known seropositive for or active viral infection with human immunodeficiency virus (HIV)
-
Positive serology for hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive and HBsAb negative, a HB DNA test will be performed and if positive the patient will be excluded. Note: If HBcAb positive and HBsAb positive, which is indicative of a past infection, the patient can be included. Patients who are seropositive because of hepatitis B virus vaccine are eligible. Consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive.
-
Positive serology for hepatitis C (HC) defined as a positive test for hepatitis C antibody (HCAb), in which case reflexively perform a HC recombinant immunoblot assay (RIBA) on the same sample to confirm the result
-
Patients who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) are ineligible.
-
Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C
-
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
-
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to randomization, congestive heart failure [New York Heart Association (NYHA) III-IV], and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities
-
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Novartis
- Celgene Corporation
Investigators
- Principal Investigator: Celeste Bello, M.D., H. Lee Moffitt Cancer Center and Research Institute
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- MCC-16622
- COMB157BUS21T
- RV-CLL-PI-0560
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Immunotherapy |
---|---|
Arm/Group Description | Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8. Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment. |
Period Title: Overall Study | |
STARTED | 45 |
COMPLETED | 44 |
NOT COMPLETED | 1 |
Baseline Characteristics
Arm/Group Title | Immunotherapy |
---|---|
Arm/Group Description | Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8. Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment. |
Overall Participants | 45 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
25
55.6%
|
>=65 years |
20
44.4%
|
Sex: Female, Male (Count of Participants) | |
Female |
17
37.8%
|
Male |
28
62.2%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
0
0%
|
Not Hispanic or Latino |
45
100%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
0
0%
|
White |
44
97.8%
|
More than one race |
0
0%
|
Unknown or Not Reported |
1
2.2%
|
Region of Enrollment (participants) [Number] | |
United States |
45
100%
|
Outcome Measures
Title | Number of Participants With Complete Response (CR) |
---|---|
Description | Number of participants with complete response, the disappearance of all signs of cancer in response to treatment. |
Time Frame | 3 Months |
Outcome Measure Data
Analysis Population Description |
---|
number of evaluable participants |
Arm/Group Title | Immunotherapy |
---|---|
Arm/Group Description | Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8. Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment. |
Measure Participants | 44 |
Count of Participants [Participants] |
1
2.2%
|
Title | Number of Participants With Partial Response (PR) |
---|---|
Description | The primary endpoint for this trial is the combined complete and partial response rate to the protocol therapy at 3 months, which is also the end of Cycle 3. The objective response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution. |
Time Frame | 3 Months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Immunotherapy |
---|---|
Arm/Group Description | Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8. Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment. |
Measure Participants | 44 |
Number [participants] |
33
73.3%
|
Title | Rate of Progression/Relapse Free Survival (PFS) |
---|---|
Description | Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier. |
Time Frame | Up to 56 months |
Outcome Measure Data
Analysis Population Description |
---|
evaluable participants |
Arm/Group Title | Immunotherapy |
---|---|
Arm/Group Description | Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8. Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment. |
Measure Participants | 24 |
Median (95% Confidence Interval) [months] |
54.4
|
Title | Number of Participants With Overall Survival (OS) |
---|---|
Description | Overall survival will be summarized with the Kaplan-Meier curve. |
Time Frame | 36 Months |
Outcome Measure Data
Analysis Population Description |
---|
evaluable participants |
Arm/Group Title | Immunotherapy |
---|---|
Arm/Group Description | Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8. Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment. |
Measure Participants | 24 |
Number [participants] |
24
53.3%
|
Adverse Events
Time Frame | Adverse events collected from day 1 up to 30 days after cycle 12, 3 years and 6 months | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Immunotherapy | |
Arm/Group Description | Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide High Dose Methylprednisolone (HDMP): HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8. Ofatumumab: Ofatumumab infusion will be administered immediately after HDMP. Lenalidomide: The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment. | |
All Cause Mortality |
||
Immunotherapy | ||
Affected / at Risk (%) | # Events | |
Total | 6/45 (13.3%) | |
Serious Adverse Events |
||
Immunotherapy | ||
Affected / at Risk (%) | # Events | |
Total | 11/45 (24.4%) | |
Blood and lymphatic system disorders | ||
Febrile Neutropenia | 4/45 (8.9%) | 4 |
Cardiac disorders | ||
Cardiac arrest | 1/45 (2.2%) | 1 |
Gastrointestinal disorders | ||
Small intestinal obstruction | 1/45 (2.2%) | 1 |
Diverticulitis | 1/45 (2.2%) | 1 |
General disorders | ||
Fever | 2/45 (4.4%) | 4 |
Non-cardiac chest pain | 1/45 (2.2%) | 1 |
Pain | 1/45 (2.2%) | 2 |
Immune system disorders | ||
Allergic Reaction | 1/45 (2.2%) | 1 |
Infections and infestations | ||
Infections and infestations - Other | 1/45 (2.2%) | 1 |
Lung infection | 1/45 (2.2%) | 1 |
Metabolism and nutrition disorders | ||
Hypercalcemia | 2/45 (4.4%) | 3 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/45 (2.2%) | 1 |
Renal and urinary disorders | ||
Acute kidney injury | 2/45 (4.4%) | 2 |
Respiratory, thoracic and mediastinal disorders | ||
Hypoxia | 1/45 (2.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Immunotherapy | ||
Affected / at Risk (%) | # Events | |
Total | 45/45 (100%) | |
Blood and lymphatic system disorders | ||
Anemia | 12/45 (26.7%) | 20 |
Blood and lymphatic system disorders - Other | 7/45 (15.6%) | 9 |
Leukocytosis | 5/45 (11.1%) | 6 |
Febrile neutropenia | 4/45 (8.9%) | 4 |
Lymph node pain | 3/45 (6.7%) | 5 |
Thrombotic thrombocytopenic purpura | 1/45 (2.2%) | 1 |
Cardiac disorders | ||
Cardiac disorders - Other | 8/45 (17.8%) | 11 |
Sinus bradycardia | 3/45 (6.7%) | 6 |
Sinus tachycardia | 3/45 (6.7%) | 4 |
Cardiac arrest | 1/45 (2.2%) | 1 |
Chest pain - cardiac | 1/45 (2.2%) | 1 |
Ear and labyrinth disorders | ||
Tinnitus | 2/45 (4.4%) | 2 |
Ear and labyrinth disorders - Other | 1/45 (2.2%) | 1 |
Ear pain | 1/45 (2.2%) | 2 |
Vertigo | 1/45 (2.2%) | 1 |
Eye disorders | ||
Eye disorders - Other | 15/45 (33.3%) | 18 |
Blurred vision | 7/45 (15.6%) | 7 |
Dry eye | 5/45 (11.1%) | 6 |
Watering eyes | 2/45 (4.4%) | 2 |
Cataract | 1/45 (2.2%) | 2 |
Floaters | 1/45 (2.2%) | 1 |
Vitreous hemorrhage | 1/45 (2.2%) | 1 |
Gastrointestinal disorders | ||
Diarrhea | 24/45 (53.3%) | 48 |
Constipation | 20/45 (44.4%) | 33 |
Nausea | 20/45 (44.4%) | 33 |
Dyspepsia | 10/45 (22.2%) | 15 |
Abdominal Pain | 9/45 (20%) | 10 |
Gastrointestinal disorders - Other | 9/45 (20%) | 9 |
Vomiting | 9/45 (20%) | 12 |
Dry mouth | 6/45 (13.3%) | 10 |
Dysphagia | 5/45 (11.1%) | 5 |
Flatulence | 4/45 (8.9%) | 5 |
Gastroesophageal reflux disease | 4/45 (8.9%) | 4 |
Oral pain | 4/45 (8.9%) | 4 |
Bloating | 3/45 (6.7%) | 4 |
Stomach pain | 3/45 (6.7%) | 3 |
Gastrointestinal pain | 2/45 (4.4%) | 2 |
Rectal hemorrhage | 2/45 (4.4%) | 2 |
Abdominal distension | 1/45 (2.2%) | 1 |
Anal pain | 1/45 (2.2%) | 1 |
Gastritis | 1/45 (2.2%) | 4 |
Hemorrhoids | 1/45 (2.2%) | 2 |
Mucositis oral | 1/45 (2.2%) | 1 |
Oral hemorrhage | 1/45 (2.2%) | 2 |
Small intestinal obstruction | 1/45 (2.2%) | 1 |
General disorders | ||
Fatigue | 22/45 (48.9%) | 40 |
Pain | 18/45 (40%) | 30 |
Infusion related reaction | 16/45 (35.6%) | 20 |
Edema limbs | 14/45 (31.1%) | 24 |
Fever | 13/45 (28.9%) | 17 |
Chills | 12/45 (26.7%) | 15 |
Flu like symptoms | 11/45 (24.4%) | 14 |
General disorders & administration site conditions-Other | 7/45 (15.6%) | 8 |
Irritability | 4/45 (8.9%) | 4 |
Non-cardiac chest pain | 3/45 (6.7%) | 4 |
Edema face | 2/45 (4.4%) | 2 |
Edema trunk | 2/45 (4.4%) | 7 |
Gait disturbance | 2/45 (4.4%) | 2 |
Injection site reaction | 2/45 (4.4%) | 2 |
Malaise | 2/45 (4.4%) | 2 |
Localized edema | 1/45 (2.2%) | 1 |
Immune system disorders | ||
Allergic reaction | 4/45 (8.9%) | 7 |
Infections and infestations | ||
Upper respiratory infection | 17/45 (37.8%) | 23 |
Sinusitis | 14/45 (31.1%) | 16 |
Infections and infestations - Other | 9/45 (20%) | 9 |
Urinary tract infection | 5/45 (11.1%) | 6 |
Rash pustular | 2/45 (4.4%) | 2 |
Skin infection | 2/45 (4.4%) | 2 |
Bronchial infection | 1/45 (2.2%) | 1 |
Conjunctivitis infective | 1/45 (2.2%) | 1 |
Eye infection | 1/45 (2.2%) | 1 |
Lung infection | 1/45 (2.2%) | 2 |
Mucosal infection | 1/45 (2.2%) | 1 |
Otitis media | 1/45 (2.2%) | 1 |
Papulopustular rash | 1/45 (2.2%) | 1 |
Rhinitis infective | 1/45 (2.2%) | 1 |
Tooth infection | 1/45 (2.2%) | 1 |
Injury, poisoning and procedural complications | ||
Bruising | 6/45 (13.3%) | 7 |
Injury, poisoning and procedural complications - Other | 3/45 (6.7%) | 6 |
Fall | 1/45 (2.2%) | 1 |
Investigations | ||
Neutrophil count decreased | 37/45 (82.2%) | 274 |
White blood cell decreased | 29/45 (64.4%) | 130 |
Platelet count decreased | 16/45 (35.6%) | 46 |
Investigations -Other | 11/45 (24.4%) | 22 |
Alanine aminotransferase increased | 10/45 (22.2%) | 24 |
Aspartate aminotransferase increased | 8/45 (17.8%) | 13 |
Lymphocycte count decreased | 6/45 (13.3%) | 7 |
Creatinine increased | 5/45 (11.1%) | 6 |
Weight loss | 4/45 (8.9%) | 6 |
Alkaline phosphatase increased | 2/45 (4.4%) | 2 |
Blood bilirubin increased | 2/45 (4.4%) | 3 |
Weight gain | 2/45 (4.4%) | 2 |
Lymphocyte count increased | 1/45 (2.2%) | 1 |
Urine output decreased | 1/45 (2.2%) | 1 |
Metabolism and nutrition disorders | ||
Metabolism and nutrition disorders -Other | 34/45 (75.6%) | 108 |
Hyperkalemia | 16/45 (35.6%) | 29 |
Hyperglycemia | 15/45 (33.3%) | 21 |
Anorexia | 12/45 (26.7%) | 15 |
Hypermagnesemia | 7/45 (15.6%) | 8 |
Hyperuricemia | 6/45 (13.3%) | 7 |
Hypocalcemia | 6/45 (13.3%) | 18 |
Hypoglycemia | 5/45 (11.1%) | 9 |
Hypercalcemia | 4/45 (8.9%) | 11 |
Hypoalbuminemia | 4/45 (8.9%) | 4 |
Hypokalemia | 4/45 (8.9%) | 11 |
Dehydration | 3/45 (6.7%) | 4 |
Hypophosphatemia | 3/45 (6.7%) | 4 |
Hyponatremia | 2/45 (4.4%) | 2 |
Musculoskeletal and connective tissue disorders | ||
Generalized muscle weakness | 14/45 (31.1%) | 17 |
Pain in extremity | 13/45 (28.9%) | 14 |
Back pain | 12/45 (26.7%) | 20 |
Myalgia | 11/45 (24.4%) | 13 |
Musculoskeletal and connective tissue disorder - Other | 8/45 (17.8%) | 13 |
Arthralgia | 7/45 (15.6%) | 10 |
Bone pain | 4/45 (8.9%) | 5 |
Muscle weakness upper limb | 3/45 (6.7%) | 3 |
Flank pain | 2/45 (4.4%) | 3 |
Muscle weakness lower limb | 2/45 (4.4%) | 2 |
Arthritis | 1/45 (2.2%) | 1 |
Chest wall pain | 1/45 (2.2%) | 1 |
Joint effusion | 1/45 (2.2%) | 1 |
Muscle weakness right-sided | 1/45 (2.2%) | 1 |
Neck pain | 1/45 (2.2%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Tumor pain | 14/45 (31.1%) | 19 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | 2/45 (4.4%) | 2 |
Nervous system disorders | ||
Peripheral sensory neuropathy | 22/45 (48.9%) | 34 |
Headache | 19/45 (42.2%) | 32 |
Movements involuntary | 17/45 (37.8%) | 26 |
Dizziness | 15/45 (33.3%) | 23 |
Paresthesia | 13/45 (28.9%) | 27 |
Dysgeusia | 9/45 (20%) | 14 |
Concentration impairment | 7/45 (15.6%) | 7 |
Memory impairment | 7/45 (15.6%) | 8 |
Nervous system disorders - Other | 6/45 (13.3%) | 7 |
Tremor | 6/45 (13.3%) | 8 |
Akathisia | 1/45 (2.2%) | 1 |
Ataxia | 1/45 (2.2%) | 1 |
Dysarthria | 1/45 (2.2%) | 1 |
Dyphasia | 1/45 (2.2%) | 1 |
Lethargy | 1/45 (2.2%) | 5 |
Sinus pain | 1/45 (2.2%) | 1 |
Psychiatric disorders | ||
Insomnia | 31/45 (68.9%) | 53 |
Anxiety | 9/45 (20%) | 14 |
Depression | 7/45 (15.6%) | 8 |
Psychiatric disorders - Other | 7/45 (15.6%) | 9 |
Agitation | 4/45 (8.9%) | 5 |
Confusion | 2/45 (4.4%) | 3 |
Euphoria | 1/45 (2.2%) | 1 |
Libido decreased | 1/45 (2.2%) | 1 |
Mania | 1/45 (2.2%) | 4 |
Renal and urinary disorders | ||
Renal and urinary disorders - Other | 7/45 (15.6%) | 11 |
Urinary frequency | 5/45 (11.1%) | 5 |
Urinary retention | 2/45 (4.4%) | 2 |
Acute kidney injury | 1/45 (2.2%) | 3 |
Bladder spasm | 1/45 (2.2%) | 1 |
Chronic kidney disease | 1/45 (2.2%) | 1 |
Hematuria | 1/45 (2.2%) | 1 |
Renal calculi | 1/45 (2.2%) | 2 |
Urinary incontinence | 1/45 (2.2%) | 3 |
Urinary tract pain | 1/45 (2.2%) | 1 |
Urine discoloration | 1/45 (2.2%) | 1 |
Reproductive system and breast disorders | ||
Reproductive system and breast disorders - Other | 2/45 (4.4%) | 2 |
Pelvic pain | 1/45 (2.2%) | 1 |
Perineal pain | 1/45 (2.2%) | 1 |
Vaginal hemorrhage | 1/45 (2.2%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Cough | 18/45 (40%) | 23 |
Dyspnea | 12/45 (26.7%) | 19 |
Sore throat | 12/45 (26.7%) | 13 |
Nasal congestion | 11/45 (24.4%) | 12 |
Productive cough | 8/45 (17.8%) | 9 |
Allergic rhinitis | 7/45 (15.6%) | 8 |
Hoarseness | 6/45 (13.3%) | 7 |
Respiratory, thoracic and mediastinal disorders - Other | 5/45 (11.1%) | 5 |
Hiccups | 3/45 (6.7%) | 3 |
Postnasal drip | 3/45 (6.7%) | 3 |
Epistaxis | 2/45 (4.4%) | 2 |
Pleural effusion | 2/45 (4.4%) | 2 |
Sinus disorder | 2/45 (4.4%) | 2 |
Bronchospasm | 1/45 (2.2%) | 1 |
Hypoxia | 1/45 (2.2%) | 1 |
Pneumonitis | 1/45 (2.2%) | 1 |
Voice alteration | 1/45 (2.2%) | 1 |
Wheezing | 1/45 (2.2%) | 1 |
Skin and subcutaneous tissue disorders | ||
Rash maculo-papular | 19/45 (42.2%) | 30 |
Skin and subcutaneous tissue disorders - Other | 16/45 (35.6%) | 25 |
Hyperhidrosis | 15/45 (33.3%) | 20 |
Pruritus | 15/45 (33.3%) | 25 |
Dry skin | 14/45 (31.1%) | 18 |
Erythema multiforme | 6/45 (13.3%) | 8 |
Alopecia | 4/45 (8.9%) | 4 |
Rash acneiform | 4/45 (8.9%) | 5 |
Skin hyperpigmentation | 2/45 (4.4%) | 2 |
Photosensitivity | 1/45 (2.2%) | 1 |
Skin ulceration | 1/45 (2.2%) | 1 |
Surgical and medical procedures | ||
Surgical and medical procedures - Other | 15/45 (33.3%) | 26 |
Vascular disorders | ||
Hypertension | 19/45 (42.2%) | 26 |
Flushing | 6/45 (13.3%) | 9 |
Hot flashes | 5/45 (11.1%) | 5 |
Hypotension | 5/45 (11.1%) | 8 |
Thromboembolic event | 2/45 (4.4%) | 2 |
Lymphedema | 1/45 (2.2%) | 1 |
Peripheral ischemia | 1/45 (2.2%) | 1 |
Vascular disorders - Other | 1/45 (2.2%) | 1 |
Limitations/Caveats
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/Title | Celeste M. Bello, MD |
---|---|
Organization | Moffitt Cancer Center |
Phone | 813-745-8623 |
Celeste.Bello@moffitt.org |
- MCC-16622
- COMB157BUS21T
- RV-CLL-PI-0560