Trial Outcomes & Findings for A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma (NCT NCT01998893)
NCT ID: NCT01998893
Last Updated: 2014-12-03
Results Overview
Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes \>1.500/ microliter (µL), hemoglobin (Hb) \>12 grams per deciliter (g/dL), and platelets \>100,000/µL. PR was defined as a less than (\<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Results posted on
2014-12-03
Participant Flow
Participant milestones
| Measure |
Rituximab
Participants received rituximab, 375 milligrams per square meter (mg/m\^2), intravenously (IV), over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
1st Treatment Cycle Completed Until PD
|
30
|
|
Overall Study
2nd Treatment Cycle Started
|
5
|
|
Overall Study
2nd Treatment Cycle Completed Until PD
|
3
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Rituximab
Participants received rituximab, 375 milligrams per square meter (mg/m\^2), intravenously (IV), over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Transformation to high-grade lymphoma
|
1
|
Baseline Characteristics
A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Rituximab
n=38 Participants
Participants received rituximab, 375 mg/m\^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Age, Customized
Less Than or Equal to (≤) 18 Years
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 Years
|
32 participants
n=5 Participants
|
|
Age, Customized
Greater Than or Equal to (≥) 65 Years
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
38 participants
n=5 Participants
|
|
Ann Arbor stage
Stage III
|
5 participants
n=5 Participants
|
|
Ann Arbor stage
Stage IV
|
33 participants
n=5 Participants
|
|
Histological subtype
Follicular or centroblastic/centrocytic lymphoma
|
32 participants
n=5 Participants
|
|
Histological subtype
Other
|
6 participants
n=5 Participants
|
|
B-Symptoms
Present
|
14 participants
n=5 Participants
|
|
B-Symptoms
Absent
|
24 participants
n=5 Participants
|
|
Bulky disease
Yes
|
10 participants
n=5 Participants
|
|
Bulky disease
No
|
28 participants
n=5 Participants
|
|
Bone marrow involvement
Yes
|
28 participants
n=5 Participants
|
|
Bone marrow involvement
No
|
10 participants
n=5 Participants
|
|
Liver involvement
Yes
|
6 participants
n=5 Participants
|
|
Liver involvement
No
|
32 participants
n=5 Participants
|
|
Spleen involvement
Yes
|
16 participants
n=5 Participants
|
|
Spleen involvement
No
|
21 participants
n=5 Participants
|
|
Spleen involvement
Missing
|
1 participants
n=5 Participants
|
|
Other extra-nodal lesions
Yes
|
8 participants
n=5 Participants
|
|
Other extra-nodal lesions
No
|
30 participants
n=5 Participants
|
|
Number of previous therapies
1 previous therapy
|
14 participants
n=5 Participants
|
|
Number of previous therapies
2 previous therapies
|
11 participants
n=5 Participants
|
|
Number of previous therapies
3 previous therapies
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)Population: ITT population
Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes \>1.500/ microliter (µL), hemoglobin (Hb) \>12 grams per deciliter (g/dL), and platelets \>100,000/µL. PR was defined as a less than (\<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
Outcome measures
| Measure |
Rituximab
n=38 Participants
Participants received rituximab, 375 mg/m\^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)
|
39.5 percentage of participants
Interval 24.0 to 56.6
|
SECONDARY outcome
Timeframe: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)Population: ITT population
Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes \>1,500/μL, Hb \>12 g/dL, and platelets \>100,000/μL. PR was defined as \<50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and \<50%. SD was defined as tumor regression \<25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
Outcome measures
| Measure |
Rituximab
n=38 Participants
Participants received rituximab, 375 mg/m\^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Number of Participants With a Clinical Response
PR
|
6 participants
|
|
Number of Participants With a Clinical Response
Missing
|
2 participants
|
|
Number of Participants With a Clinical Response
MR
|
3 participants
|
|
Number of Participants With a Clinical Response
SD
|
16 participants
|
|
Number of Participants With a Clinical Response
PD
|
2 participants
|
|
Number of Participants With a Clinical Response
CR
|
9 participants
|
SECONDARY outcome
Timeframe: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)Population: ITT population; only participants with at least one application of study treatment within the first 4 weeks of treatment were included in the analysis.
The median time, in months, from start of the treatment (first application) until best response (PR or CR).
Outcome measures
| Measure |
Rituximab
n=15 Participants
Participants received rituximab, 375 mg/m\^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Time to Best Response
|
1.9 months
Interval 1.1 to 5.7
|
SECONDARY outcome
Timeframe: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)Population: Participants in the ITT population with CR or PR after the first treatment cycle.
Median time, in months, between the documentation of CR or PR and PD in clinical responders.
Outcome measures
| Measure |
Rituximab
n=15 Participants
Participants received rituximab, 375 mg/m\^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Duration of Remission
|
12.7 months
Interval 5.6 to 35.0
|
SECONDARY outcome
Timeframe: Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)Population: ITT population
The median time, in months, from the start of treatment (first application) until detection of PD.
Outcome measures
| Measure |
Rituximab
n=38 Participants
Participants received rituximab, 375 mg/m\^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Time to Progression
|
6.6 months
Interval 4.8 to 15.3
|
SECONDARY outcome
Timeframe: Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)Population: ITT population
OS was defined as the time, in months, between enrollment into the study and death, due to any cause. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
Outcome measures
| Measure |
Rituximab
n=38 Participants
Participants received rituximab, 375 mg/m\^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Overall Survival (OS)
|
49.6 months
Interval 15.3 to
The statistical analysis system (SAS) could not compute the upper boundary of the confidence interval due to the large number of censored events.
|
SECONDARY outcome
Timeframe: First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).Population: Participants in the ITT population who began a second cycle of treatment.
Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD. CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes \>1,500/μL, Hb \>12 g/dL, and platelets \>100,000/μL. PR was defined as \<50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and \<50%. SD was defined as tumor regression \<25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
Outcome measures
| Measure |
Rituximab
n=5 Participants
Participants received rituximab, 375 mg/m\^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Number of Participants With a Clinical Response to Re-Treatment
CR
|
1 participants
|
|
Number of Participants With a Clinical Response to Re-Treatment
PR
|
0 participants
|
|
Number of Participants With a Clinical Response to Re-Treatment
MR
|
0 participants
|
|
Number of Participants With a Clinical Response to Re-Treatment
SD
|
3 participants
|
|
Number of Participants With a Clinical Response to Re-Treatment
PD
|
0 participants
|
|
Number of Participants With a Clinical Response to Re-Treatment
Missing
|
1 participants
|
Adverse Events
Rituximab
Serious events: 10 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab
n=38 participants at risk
Participants received rituximab, 375 mg/m\^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Immune system disorders
Allergy
|
2.6%
1/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Blood and lymphatic system disorders
Lymphocytes
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Cardiac disorders
Dysrhythmias
|
2.6%
1/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Cardiac disorders
Sinus tachycardia
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
General disorders
Lethargy (fatigue, malaise)
|
2.6%
1/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Infections and infestations
Infection
|
2.6%
1/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.6%
1/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath (including wheezing)
|
2.6%
1/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
Other adverse events
| Measure |
Rituximab
n=38 participants at risk
Participants received rituximab, 375 mg/m\^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobine
|
7.9%
3/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Blood and lymphatic system disorders
Lymphocytes
|
13.2%
5/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Blood and lymphatic system disorders
Platelets
|
15.8%
6/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Blood and lymphatic system disorders
White blood count
|
7.9%
3/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Blood and lymphatic system disorders
Blood/bone marrow: other (not specified)
|
10.5%
4/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Cardiac disorders
Dysrhythmias
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Cardiac disorders
Sinus tachycardia
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Gastrointestinal disorders
Esophagitis/dysphagia/odonophagia (including recall reaction)
|
7.9%
3/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Gastrointestinal disorders
Nausea
|
13.2%
5/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Gastrointestinal disorders
Vomitting
|
7.9%
3/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Gastrointestinal disorders
Gastrointestinal: other (not specified)
|
7.9%
3/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
General disorders
Fever in absence of infection (including drug fever)
|
36.8%
14/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
General disorders
Lethargy (fatigue, malaise)
|
13.2%
5/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
General disorders
Myalgia
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
General disorders
Rigor/chills (grade 3 including cyanosis)
|
31.6%
12/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
General disorders
Flue-like symptoms: other (not specified)
|
10.5%
4/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Hepatobiliary disorders
Bilirubin
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Hepatobiliary disorders
Lactate dehydrogenase (LDH)
|
10.5%
4/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Hepatobiliary disorders
Alanine transaminase (ALT)
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Hepatobiliary disorders
Hepatic: other (not specified)
|
7.9%
3/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Immune system disorders
Allergy
|
10.5%
4/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Infections and infestations
Infection
|
31.6%
12/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Investigations
Coagulation: other (not specified)
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Metabolism and nutrition disorders
Metabolic: other (not specified)
|
15.8%
6/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Nervous system disorders
Headache
|
18.4%
7/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Nervous system disorders
Sensory
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Nervous system disorders
Neurologic: other (not specified)
|
7.9%
3/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Renal and urinary disorders
Genitourinary: other (not specifed)
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath (including wheezing)
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Skin and subcutaneous tissue disorders
Rash/itch (not due to allergy, including recall reaction)
|
18.4%
7/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Skin and subcutaneous tissue disorders
Skin: other (not specified)
|
7.9%
3/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Vascular disorders
Edema
|
5.3%
2/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
|
Vascular disorders
Hypotension
|
7.9%
3/38 • Adverse events (AEs) were reported from the beginning of study treatment until PD or last available follow-up in the first or the second treatment cycle. The median length of follow up was 6.7 months (range: 0-97.8 months).
All participants who received at least 1 dose of study drug. AEs were collected according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grading System revised on December 21st, 1994.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER