Trial Outcomes & Findings for Zidovudine, Interferon Alfa-2b, PEG-Interferon Alfa-2b in Patients With HTLV-I Associated Adult T-Cell Leukemia/Lymphoma (NCT NCT00854581)
NCT ID: NCT00854581
Last Updated: 2018-04-17
Results Overview
Number of patients achieving clinical response (complete response (CR) + partial response (PR)) who lack interferon regulatory factor 4 (IRF-4) or c-Rel biomarker expression. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009. For imaging, Cheson criteria was used to assess response: * Complete response (CR): Disappearance of all clinical, microscopic, and radiographic evidence of disease. All lymph nodes regressed to normal size (≤ 1.5 cm), and previously involved nodes that were 1.1 to 1.5 cm decreased to ≤ 1.0 cm. In addition, abnormally elevated peripheral blood absolute lymphocyte count (ALC) \< 4 x 10\^9 /L. * Partial response (PR): ≥ 50% reduction in measurable disease and abnormal lymphocyte count in peripheral blood. * CR or PR had to persist for a period of at least 4 weeks.
TERMINATED
PHASE4
13 participants
Up to 12 months post-initiation of protocol therapy
2018-04-17
Participant Flow
Participant milestones
| Measure |
Induction + Maintenance
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
|
|---|---|
|
Induction (Up to Day 21)
STARTED
|
13
|
|
Induction (Up to Day 21)
COMPLETED
|
7
|
|
Induction (Up to Day 21)
NOT COMPLETED
|
6
|
|
Part 1 Maintenance (Up to Day 60)
STARTED
|
7
|
|
Part 1 Maintenance (Up to Day 60)
COMPLETED
|
5
|
|
Part 1 Maintenance (Up to Day 60)
NOT COMPLETED
|
2
|
|
Part 2 Maintenance (Up to 12 Months)
STARTED
|
5
|
|
Part 2 Maintenance (Up to 12 Months)
COMPLETED
|
2
|
|
Part 2 Maintenance (Up to 12 Months)
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Induction + Maintenance
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
|
|---|---|
|
Induction (Up to Day 21)
Lack of Efficacy
|
4
|
|
Induction (Up to Day 21)
Death
|
1
|
|
Induction (Up to Day 21)
Physician Decision
|
1
|
|
Part 2 Maintenance (Up to 12 Months)
Lack of Efficacy
|
3
|
Baseline Characteristics
Zidovudine, Interferon Alfa-2b, PEG-Interferon Alfa-2b in Patients With HTLV-I Associated Adult T-Cell Leukemia/Lymphoma
Baseline characteristics by cohort
| Measure |
Induction + Maintenance
n=13 Participants
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 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
|
|
Race/Ethnicity, Customized
Brazil
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Dominican Republic
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Haiti
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Jamaica
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
St. Croix
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Trinidad
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post-initiation of protocol therapyPopulation: All participants who had a treatment response (PR or CR)
Number of patients achieving clinical response (complete response (CR) + partial response (PR)) who lack interferon regulatory factor 4 (IRF-4) or c-Rel biomarker expression. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009. For imaging, Cheson criteria was used to assess response: * Complete response (CR): Disappearance of all clinical, microscopic, and radiographic evidence of disease. All lymph nodes regressed to normal size (≤ 1.5 cm), and previously involved nodes that were 1.1 to 1.5 cm decreased to ≤ 1.0 cm. In addition, abnormally elevated peripheral blood absolute lymphocyte count (ALC) \< 4 x 10\^9 /L. * Partial response (PR): ≥ 50% reduction in measurable disease and abnormal lymphocyte count in peripheral blood. * CR or PR had to persist for a period of at least 4 weeks.
Outcome measures
| Measure |
Induction + Maintenance
n=6 Participants
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
|
|---|---|
|
Number of Patients Achieving Clinical Response to Protocol Therapy Who Lack IRF-4 and/or c-Rel Expression.
Participants with tumors lacking IRF-4
|
5 participants
|
|
Number of Patients Achieving Clinical Response to Protocol Therapy Who Lack IRF-4 and/or c-Rel Expression.
Participants with tumors lacking c-Rel
|
2 participants
|
PRIMARY outcome
Timeframe: 3, 6 and 12 months.Population: Participants who achieved CR with minimal residual disease in Part 1 Maintenance therapy at Month 3 and moved on the Part 2B maintenance for up to 12 months.
Number of participants achieving complete response (CR) with minimal residual disease at 3, 6 and 12 months post-initiation of protocol therapy. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009. For imaging, Cheson criteria was used to assess response: * Complete response (CR): Disappearance of all clinical, microscopic, and radiographic evidence of disease. All lymph nodes regressed to normal size (≤ 1.5 cm), and previously involved nodes that were 1.1 to 1.5 cm decreased to ≤ 1.0 cm. In addition, abnormally elevated peripheral blood absolute lymphocyte count (ALC) \< 4 x 10\^9 /L. * Partial response (PR): ≥ 50% reduction in measurable disease and abnormal lymphocyte count in peripheral blood. * CR or PR had to persist for a period of at least 4 weeks.
Outcome measures
| Measure |
Induction + Maintenance
n=3 Participants
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
|
|---|---|
|
Presence of Minimal Residual Disease at 3 and 6 Months of Maintained Remission and at 1 Year Post Initiation of Therapy
3 months, CR w/minimal residual disease
|
3 participants
|
|
Presence of Minimal Residual Disease at 3 and 6 Months of Maintained Remission and at 1 Year Post Initiation of Therapy
6 months, CR w/minimal residual disease
|
1 participants
|
|
Presence of Minimal Residual Disease at 3 and 6 Months of Maintained Remission and at 1 Year Post Initiation of Therapy
12 months, CR w/minimal residual disease
|
0 participants
|
PRIMARY outcome
Timeframe: At time of relapse or disease progression, assessed up to 12 monthsPopulation: Study participants were tested for these markers at baseline, but only IRF4 was re-tested at relapse
Expressions of c-Rel, IRF-4 or other molecular events (p53, p16 mutations) including expansion of novel clones obtained at time of relapse will be compared to baseline data using paired t-test.
Outcome measures
| Measure |
Induction + Maintenance
n=12 Participants
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
|
|---|---|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Baseline p15/16 alterations, heterozygous deletion
|
2 participants
|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Baseline p15/16 alterations, no deletions
|
2 participants
|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Baseline IRF-4 Expression, Positive
|
3 participants
|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Baseline IRF-4 Expression, Negative
|
9 participants
|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
IRF-4 Expression at Relapse, Newly Positive
|
2 participants
|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Baseline c-Rel Expression, Faintly Positive
|
3 participants
|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Baseline c-Rel Expression, Positive
|
2 participants
|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Baseline c-Rel Expression, Negative
|
3 participants
|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Baseline p53 Expression, Positive
|
1 participants
|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Baseline p53 Expression, Negative
|
5 participants
|
|
Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Baseline p15/16 alterations, homozygous deletion
|
1 participants
|
PRIMARY outcome
Timeframe: During 48 hours of first AZT therapyPopulation: Participants receiving Zidovudine (AZT) therapy who achieved complete response (CR) or partial response (PR).
Number of patients exhibiting NF-kb inhibition upon treatment with AZT in vivo. Investigation of whether AZT functions as an inhibitor of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) in vivo by analyzing serially collected leukemic samples during the first 48 hours of treatment with AZT only. The investigators will report the number of participants exhibiting NF-kB inhibition upon treatment with AZT in vivo and correlate with response using two-sample t-test.
Outcome measures
| Measure |
Induction + Maintenance
n=4 Participants
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
|
|---|---|
|
Number of Participants Exhibiting NF-kB Inhibition Upon Treatment With AZT in Vivo
PR with Decrease in p50, and Increase in p65
|
1 participants
|
|
Number of Participants Exhibiting NF-kB Inhibition Upon Treatment With AZT in Vivo
CR with Decrease in NF-kB Complex (p50 complexes)
|
1 participants
|
|
Number of Participants Exhibiting NF-kB Inhibition Upon Treatment With AZT in Vivo
CR with no clear effect NF-kB
|
1 participants
|
PRIMARY outcome
Timeframe: 3, 6 and 12 months.Population: Participants achieving CR or PR in Part 1 Maintenance and moving on to Part 2B Maintenance therapy
Number of participants achieving a molecular remission after starting valproic acid as evidenced by disappearance of T-cell clonality as measured by gene rearrangement studies using multiplex PCR
Outcome measures
| Measure |
Induction + Maintenance
n=3 Participants
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
|
|---|---|
|
The Effect of Valproic Acid Therapy on Persistence of Clonal Disease in Patients Who Achieve Clinical Remission
3 months, CR or PR, with molecular remission
|
0 participants
|
|
The Effect of Valproic Acid Therapy on Persistence of Clonal Disease in Patients Who Achieve Clinical Remission
6 months, CR with molecular remission
|
1 participants
|
|
The Effect of Valproic Acid Therapy on Persistence of Clonal Disease in Patients Who Achieve Clinical Remission
9 months, CR with molecular remission
|
1 participants
|
|
The Effect of Valproic Acid Therapy on Persistence of Clonal Disease in Patients Who Achieve Clinical Remission
12 months, CR with molecular remission
|
1 participants
|
SECONDARY outcome
Timeframe: From date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause, assessed up to 5 yearsFailure-free survival is the elapsed time from the date of initiation of study treatment until date of documented disease progression, relapse after response, or death from any cause. For patients alive and free of relapse or progression, follow-up time was censored at the last documented date of failure-free status.
Outcome measures
| Measure |
Induction + Maintenance
n=13 Participants
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
|
|---|---|
|
Failure-free Survival (FFS)
|
2.7 months
Interval 1.0 to 6.9
|
SECONDARY outcome
Timeframe: From date of treatment initiation until date of death, assessed up to 5 yearsOverall survival (OS) is the elapsed time from the date of initiation of study treatment until date of death from any cause. In the absence of death, the follow-up was censored at date of last contact.
Outcome measures
| Measure |
Induction + Maintenance
n=13 Participants
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
|
|---|---|
|
Overall Survival
|
7.8 months
Interval 2.5 to 46.6
|
Adverse Events
Induction Therapy
Part 1 Maintenance
Part 2A Maintenance
Part 2B Maintenance
Serious adverse events
| Measure |
Induction Therapy
n=13 participants at risk
For one cycle, up to Day 21. All participants are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR). Participants who achieve a clinical CR at Day 14 response assessment will go on to Part 1 maintenance therapy. Patients who achieve a PR will receive 7 more days of induction therapy and then go on to Part 1 Maintenance Therapy.:
* Zidovudine:
* Days 1-2: 1.5 grams intravenously (IV) twice daily
* Days 3-21: 1.5 grams IV twice daily
* Interferon alfa-2b (IFN):
* 5 10 million units (mu) intravenously twice daily
|
Part 1 Maintenance
n=7 participants at risk
From Treatment Day 14 or 21 to start of Month 3 (Day 60). Study participants move on to Part 1 Maintenance Therapy only if they achieve complete response (CR) or partial response (PR) after induction therapy. Restaging and molecular evaluation of disease at start of Month 3:
* Zidovudine: 600 mg orally twice daily in all phases of Maintenance Therapy
* PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly
* Participants then proceed to Part 2 maintenance.
|
Part 2A Maintenance
n=2 participants at risk
Participants achieving a CR with undetectable clonal disease. Participants will receive therapy for as long as response is maintained:
* Zidovudine: 600 mg orally twice daily
* PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly
|
Part 2B Maintenance
n=3 participants at risk
Participants achieving a CR with minimal residual disease (by multiplex PCR) or PR in Part 1:
* Zidovudine: 600 mg or 300 mg orally twice daily, per protocol
* PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly, per protocol
* Valproic acid, 250 mg orally twice daily, per protocol
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/13
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Infection - Other
|
15.4%
2/13 • Number of events 2
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Infection, Catheter-related
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Neutrophils
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/13
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
Other adverse events
| Measure |
Induction Therapy
n=13 participants at risk
For one cycle, up to Day 21. All participants are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR). Participants who achieve a clinical CR at Day 14 response assessment will go on to Part 1 maintenance therapy. Patients who achieve a PR will receive 7 more days of induction therapy and then go on to Part 1 Maintenance Therapy.:
* Zidovudine:
* Days 1-2: 1.5 grams intravenously (IV) twice daily
* Days 3-21: 1.5 grams IV twice daily
* Interferon alfa-2b (IFN):
* 5 10 million units (mu) intravenously twice daily
|
Part 1 Maintenance
n=7 participants at risk
From Treatment Day 14 or 21 to start of Month 3 (Day 60). Study participants move on to Part 1 Maintenance Therapy only if they achieve complete response (CR) or partial response (PR) after induction therapy. Restaging and molecular evaluation of disease at start of Month 3:
* Zidovudine: 600 mg orally twice daily in all phases of Maintenance Therapy
* PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly
* Participants then proceed to Part 2 maintenance.
|
Part 2A Maintenance
n=2 participants at risk
Participants achieving a CR with undetectable clonal disease. Participants will receive therapy for as long as response is maintained:
* Zidovudine: 600 mg orally twice daily
* PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly
|
Part 2B Maintenance
n=3 participants at risk
Participants achieving a CR with minimal residual disease (by multiplex PCR) or PR in Part 1:
* Zidovudine: 600 mg or 300 mg orally twice daily, per protocol
* PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly, per protocol
* Valproic acid, 250 mg orally twice daily, per protocol
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/13
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
0.00%
0/13
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Anorexia
|
15.4%
2/13 • Number of events 2
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
15.4%
2/13 • Number of events 4
|
14.3%
1/7 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Chills
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Edema limbs
|
23.1%
3/13 • Number of events 3
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Edema: Head and Neck
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Fatigue
|
0.00%
0/13
|
28.6%
2/7 • Number of events 2
|
0.00%
0/2
|
66.7%
2/3 • Number of events 3
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
7.7%
1/13 • Number of events 2
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Heartburn
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Hemoglobin
|
23.1%
3/13 • Number of events 7
|
14.3%
1/7 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
15.4%
2/13 • Number of events 3
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.1%
3/13 • Number of events 4
|
28.6%
2/7 • Number of events 2
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
46.2%
6/13 • Number of events 8
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.4%
2/13 • Number of events 3
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Infection - Other
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Infection, Bladder (urinary)
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Infection, normal ANC, Catheter-related
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Infection, Urinary tract NOS
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Leukocytes
|
15.4%
2/13 • Number of events 4
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 2
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Investigations
Neutrophil count decreased
|
38.5%
5/13 • Number of events 7
|
0.00%
0/7
|
50.0%
1/2 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophils
|
30.8%
4/13 • Number of events 6
|
0.00%
0/7
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.4%
2/13 • Number of events 2
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
7.7%
1/13 • Number of events 2
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Rigors/chills
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Endocrine disorders
Scleral necrosis
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13
|
0.00%
0/7
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1
|
0.00%
0/7
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 2
|
0.00%
0/7
|
0.00%
0/2
|
33.3%
1/3 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place