Trial Outcomes & Findings for Vorinostat, Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT00918723)
NCT ID: NCT00918723
Last Updated: 2020-02-25
Results Overview
The MTD of vorinostat in combination with FCR will be defined as the dose level immediately below the dose level at which greater than or equal to 2 patients out of 6 of a cohort experience dose-limiting toxicity. Toxicities will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Doses of vorinostat analyzed to reach the MTD were 200 mg, 300 mg and 400 mg.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
28 days
Results posted on
2020-02-25
Participant Flow
Participant milestones
| Measure |
Treatment (Induction and Maintenance Chemotherapy)
INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.
Fludarabine Phosphate: Given IV
Cyclophosphamide: Given IV
Rituximab: Given IV
Vorinostat: Given PO
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vorinostat, Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Induction and Maintenance Chemotherapy)
n=40 Participants
INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.
Fludarabine Phosphate: Given IV
Cyclophosphamide: Given IV
Rituximab: Given IV
Vorinostat: Given PO
|
|---|---|
|
Age, Continuous
|
58 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
|
Rai stage at the time of diagnosis
Rai stage 0
|
15 Participants
n=93 Participants
|
|
Rai stage at the time of diagnosis
Rai stage I/II
|
19 Participants
n=93 Participants
|
|
Rai stage at the time of diagnosis
Rai stage III/IV
|
6 Participants
n=93 Participants
|
|
Rai stage at the time of treatment
Rai stage 0
|
0 Participants
n=93 Participants
|
|
Rai stage at the time of treatment
Rai stage I/II
|
23 Participants
n=93 Participants
|
|
Rai stage at the time of treatment
Rai stage III/IV
|
17 Participants
n=93 Participants
|
|
Time to treatment
|
27 months
n=93 Participants
|
|
B symptoms
|
13 Participants
n=93 Participants
|
|
del 17p (Cytogenetics/immunophenotypic characteristics)
|
2 Participants
n=93 Participants
|
|
del 11q (Cytogenetics/immunophenotypic characteristics)
|
2 Participants
n=93 Participants
|
|
Trisomy 12 (Cytogenetics/immunophenotypic characteristics)
|
4 Participants
n=93 Participants
|
|
del 13q (Cytogenetics/immunophenotypic characteristics)
|
3 Participants
n=93 Participants
|
|
Normal cytogenetic (Cytogenetics/immunophenotypic characteristics)
|
14 Participants
n=93 Participants
|
|
Other chromosomal abnormalities (Cytogenetics/immunophenotypic characteristics)
|
6 Participants
n=93 Participants
|
|
High CD38 expression (> 30%) (Cytogenetics/immunophenotypic characteristics)
|
20 Participants
n=93 Participants
|
|
High ZAP-70 (> 20%) (Cytogenetics/immunophenotypic characteristics)
|
14 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 28 daysThe MTD of vorinostat in combination with FCR will be defined as the dose level immediately below the dose level at which greater than or equal to 2 patients out of 6 of a cohort experience dose-limiting toxicity. Toxicities will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Doses of vorinostat analyzed to reach the MTD were 200 mg, 300 mg and 400 mg.
Outcome measures
| Measure |
MTD for Vorinostat During Induction Therapy
n=40 Participants
MTD for patients who started induction therapy with FCR + vorinostat. Induction therapy: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Fludarabine Phosphate: Given IV
Cyclophosphamide: Given IV
Rituximab: Given IV
Vorinostat: Given PO
|
MTD for Vorinostat During Maintenance Therapy
n=26 Participants
MTD for patients who started Rituximab + Vorinostat Maintenance Therapy. Maintenance therapy: Following 4-6 cycles of FCR plus vorinostat, maintenance Rituximab + Vorinostat will be given every 3 months (+/- two weeks) for 2 years. Vorinostat is given PO on days 1-14 of cycles.
Rituximab: Given IV
Vorinostat: Given PO
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) of Vorinostat That Can be Combined With Fludarabine Phosphate, Cyclophosphamide and Rituximab (FCR) (Phase I)
|
400 mg
|
400 mg
|
PRIMARY outcome
Timeframe: 2 yearsProgression-free survival (PFS): The length of time during and after the treatment that a patient lives with the disease but it does not get worse. Progressive disease is specified by the NCI (National Cancer Institute) working group guidelines and additional CT (computerized tomography) scan requirements: Lymphadenopathy, \> 50% increase in the sum of the products of at least two lymph nodes on two consecutive determinations; one lymph node must be at least 2 cm. An increase in the liver or spleen size by 50% or more by CT scan or the de novo appearance of hepatomegaly or splenomegaly. An increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter. Transformation to a more aggressive histology or occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL.
Outcome measures
| Measure |
MTD for Vorinostat During Induction Therapy
n=40 Participants
MTD for patients who started induction therapy with FCR + vorinostat. Induction therapy: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Fludarabine Phosphate: Given IV
Cyclophosphamide: Given IV
Rituximab: Given IV
Vorinostat: Given PO
|
MTD for Vorinostat During Maintenance Therapy
MTD for patients who started Rituximab + Vorinostat Maintenance Therapy. Maintenance therapy: Following 4-6 cycles of FCR plus vorinostat, maintenance Rituximab + Vorinostat will be given every 3 months (+/- two weeks) for 2 years. Vorinostat is given PO on days 1-14 of cycles.
Rituximab: Given IV
Vorinostat: Given PO
|
|---|---|---|
|
Percentage of Patients With Progression-free Survival at 2 Years
|
87 percentage of participants
Interval 71.0 to 94.0
|
—
|
PRIMARY outcome
Timeframe: 2 yearsOverall survival (OS): The percentage of people in a study who are still alive at for a certain period of time after they started treatment.
Outcome measures
| Measure |
MTD for Vorinostat During Induction Therapy
n=40 Participants
MTD for patients who started induction therapy with FCR + vorinostat. Induction therapy: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Fludarabine Phosphate: Given IV
Cyclophosphamide: Given IV
Rituximab: Given IV
Vorinostat: Given PO
|
MTD for Vorinostat During Maintenance Therapy
MTD for patients who started Rituximab + Vorinostat Maintenance Therapy. Maintenance therapy: Following 4-6 cycles of FCR plus vorinostat, maintenance Rituximab + Vorinostat will be given every 3 months (+/- two weeks) for 2 years. Vorinostat is given PO on days 1-14 of cycles.
Rituximab: Given IV
Vorinostat: Given PO
|
|---|---|---|
|
Overall Survival
|
90 percentage of participants
Interval 75.0 to 96.0
|
—
|
SECONDARY outcome
Timeframe: Within 21 days prior to starting maintenance therapyPopulation: Patients who achieved a complete response (CR) after induction therapy and had minimal residual disease (MRD) status tested using flow cytometry
Outcome measures
| Measure |
MTD for Vorinostat During Induction Therapy
n=23 Participants
MTD for patients who started induction therapy with FCR + vorinostat. Induction therapy: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Fludarabine Phosphate: Given IV
Cyclophosphamide: Given IV
Rituximab: Given IV
Vorinostat: Given PO
|
MTD for Vorinostat During Maintenance Therapy
MTD for patients who started Rituximab + Vorinostat Maintenance Therapy. Maintenance therapy: Following 4-6 cycles of FCR plus vorinostat, maintenance Rituximab + Vorinostat will be given every 3 months (+/- two weeks) for 2 years. Vorinostat is given PO on days 1-14 of cycles.
Rituximab: Given IV
Vorinostat: Given PO
|
|---|---|---|
|
To Eliminate Residual Disease (Documented by Flow Cytometry and/or Polymerase Chain Reaction [PCR]) in Patients Who Have Achieved Complete Response (CR) After Fludarabine, Cyclophosphamide, and Rituximab (FCR) Plus Vorinostat
MRD negative
|
21 Participants
|
—
|
|
To Eliminate Residual Disease (Documented by Flow Cytometry and/or Polymerase Chain Reaction [PCR]) in Patients Who Have Achieved Complete Response (CR) After Fludarabine, Cyclophosphamide, and Rituximab (FCR) Plus Vorinostat
MRD positive
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: After completion of maintenance therapy (24 months after start of maintenance)Population: Participants who had a partial response (PR) or nodular partial response (nPR) after FCR+vorinostat induction therapy, as measured within 21 days of starting maintenance therapy. Maintenance therapy began within 3 months after completion of induction therapy with FCR+vorinostat.
Responses were measured after completion of FCR+ vorinostat induction therapy (within 21 days of starting maintenance) and again after completion of maintenance therapy (24 months after the start of maintenance therapy). Maintenance therapy began within 3 months after completion of induction therapy with FCR+vorinostat. Criteria for response are specified by the National Cancer Institute (NCI) working group guidelines; in addition, patients were required to meet computed tomography (CT) criteria as described in the protocol. Response categories include Complete Response (CR), Partial Response (PR), Nodular Partial Response (nPR), Stable Disease (SD) or Progressive Disease (PD).
Outcome measures
| Measure |
MTD for Vorinostat During Induction Therapy
n=6 Participants
MTD for patients who started induction therapy with FCR + vorinostat. Induction therapy: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Fludarabine Phosphate: Given IV
Cyclophosphamide: Given IV
Rituximab: Given IV
Vorinostat: Given PO
|
MTD for Vorinostat During Maintenance Therapy
MTD for patients who started Rituximab + Vorinostat Maintenance Therapy. Maintenance therapy: Following 4-6 cycles of FCR plus vorinostat, maintenance Rituximab + Vorinostat will be given every 3 months (+/- two weeks) for 2 years. Vorinostat is given PO on days 1-14 of cycles.
Rituximab: Given IV
Vorinostat: Given PO
|
|---|---|---|
|
To Estimate the Rate of Conversion of Partial Response (PR) to Complete Response (CR) After Fludarabine, Cyclophosphamide and Rituximab (FCR) Plus Vorinostat
Conversion from PR to CR
|
50 percentage of participants
|
—
|
|
To Estimate the Rate of Conversion of Partial Response (PR) to Complete Response (CR) After Fludarabine, Cyclophosphamide and Rituximab (FCR) Plus Vorinostat
Conversion from nPR (nodular PR) to CR
|
100 percentage of participants
|
—
|
Adverse Events
Treatment (Induction and Maintenance Chemotherapy)
Serious events: 17 serious events
Other events: 40 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Induction and Maintenance Chemotherapy)
n=40 participants at risk
INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.
Fludarabine Phosphate: Given IV
Cyclophosphamide: Given IV
Rituximab: Given IV
Vorinostat: Given PO
|
|---|---|
|
Infections and infestations
Sepsis Grade 5
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
General disorders
Infusion reaction Grade 3
|
5.0%
2/40 • Number of events 2 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastroenteritis Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
General disorders
Dehydration Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Infections and infestations
Bronchiectasis Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Infections and infestations
Sepsis Grade 4
|
5.0%
2/40 • Number of events 2 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Cardiac disorders
Bradychardia Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Infections and infestations
Sepsis Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Vascular disorders
Venous thromboemoblism Grade 4
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Immune system disorders
Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome - Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
General disorders
Elective surgery
|
5.0%
2/40 • Number of events 2 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
Other adverse events
| Measure |
Treatment (Induction and Maintenance Chemotherapy)
n=40 participants at risk
INDUCTION THERAPY: Patients receive vorinostat PO once daily on days 1-5 and 8-12; cyclophosphamide IV over 30-60 minutes and fludarabine phosphate IV over 30-60 minutes on days 1-3; and rituximab IV on day 1, 2, 3, 4, or 5. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 3 months after the completion of induction therapy, patients receive vorinostat PO on days 1-14 and rituximab IV on day 1. Treatment repeats every 3 months for 2 years in the absence of disease progression or unacceptable toxicity.
Fludarabine Phosphate: Given IV
Cyclophosphamide: Given IV
Rituximab: Given IV
Vorinostat: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia Grade 3
|
5.0%
2/40 • Number of events 2 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia Grade 2
|
25.0%
10/40 • Number of events 10 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia Grade 3
|
20.0%
8/40 • Number of events 8 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia Grade 3
|
30.0%
12/40 • Number of events 12 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia Grade 4
|
40.0%
16/40 • Number of events 16 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia Grade 4
|
20.0%
8/40 • Number of events 8 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia Grade 2
|
15.0%
6/40 • Number of events 6 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia Grade 3
|
15.0%
6/40 • Number of events 6 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia Grade 4
|
10.0%
4/40 • Number of events 4 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea Grade 3
|
10.0%
4/40 • Number of events 4 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting Grade 3
|
5.0%
2/40 • Number of events 2 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation Grade 3
|
5.0%
2/40 • Number of events 2 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea Grade 3
|
10.0%
4/40 • Number of events 4 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastroenteritis Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Hyperbilirubinemia Grade 2
|
10.0%
4/40 • Number of events 4 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Hyperbilirubinemia Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Elevated alkaline phosphatase Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Elevated AST Grade 4
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Elevated AST Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Hypoalbuminemia Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Elevated lipase Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis Grade 4
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Hypokalemia Grade 3
|
5.0%
2/40 • Number of events 2 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Hypokalemia Grade 4
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dehydration Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Hypophosphatemia Grade 3
|
7.5%
3/40 • Number of events 3 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Renal dysfunction Grade 2
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Renal dysfunction Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Hyponatremia Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Hypouricemia Grade 4
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Investigations
Hypocalcemia Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Cardiac disorders
Hypertension Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Cardiac disorders
Vasovagal episode Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Vascular disorders
Venous thromboembolism Grade 3
|
5.0%
2/40 • Number of events 2 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Vascular disorders
Venous thromboembolism Grade 4
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia Grade 4
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome Grade 4
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Infections and infestations
Bronchiectasis Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
General disorders
Infusion reaction Grade 2
|
35.0%
14/40 • Number of events 14 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
General disorders
Infusion reaction Grade 3
|
10.0%
4/40 • Number of events 4 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
General disorders
Infusion reaction Grade 4
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
General disorders
Fatigue Grade 1
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
General disorders
Fatigue Grade 3
|
10.0%
4/40 • Number of events 4 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Nervous system disorders
Headache Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Inguinal pain Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma Grade 3
|
5.0%
2/40 • Number of events 2 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
General disorders
Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycemia Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Mood alteration Grade 3
|
2.5%
1/40 • Number of events 1 • For each participant, adverse events were collected during treatment and for 30 days after the last dose of study drug.
|
Additional Information
Dr. Mazyar Shadman
Fred Hutchinson Cancer Research Center
Phone: 2066675467
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place