Trial Outcomes & Findings for Pentostatin, Cyclophosphamide, and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL (NCT NCT00074282)
NCT ID: NCT00074282
Last Updated: 2023-06-29
Results Overview
Percent with response (CR, nPR, PR) with two-stage 90% confidence interval
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
8 weeks after Cycle 6
Results posted on
2023-06-29
Participant Flow
Patients were recruited from ECOG-ACRIN institutions between 12/16/04 and 5/6/13. The first patient was accrued on 4/14/05.
Participant milestones
| Measure |
Arm A (PCR)
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.
Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.
Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.
rituximab
cyclophosphamide
pentostatin
|
Arm B (Alemtuzumab: CR, nPR)
Patients who achieved a confirmed CR or nPR, were registered to receive Alemtuzumab (Arm B). When the patient was registered to Arm B, the drug was administered three times a week for four weeks. The dose was 30 mg per dose. A twelve-week treatment-free period had to elapse before CAMPATH-1H began following completion of PCR for Arm B patients
Alemtuzumab
|
Arm C (Alemtuzumab: PR, <PR, PD)
For those patients not achieving a CR or nPR (thus patients either achieved PR, SD, or PD), Alemtuzumab (Arm C) was administered three times a week for eighteen weeks at a dose of 30 mg TIW. For PR, SD and PD patients, the timing of CAMPATH-1H was left to the discretion of the investigator, and treatment could begin earlier but no less than two weeks and no longer than eight weeks after the completion of the last PCR course. Patients determined to have PD during treatment with PCR did not need to complete all 6 cycles of PCR to go on to Arm C, however, completing a minimum of 2 cycles was required.
Alemtuzumab
|
|---|---|---|---|
|
Step 1
STARTED
|
102
|
0
|
0
|
|
Step 1
Eligible
|
98
|
0
|
0
|
|
Step 1
Started Treatment
|
96
|
0
|
0
|
|
Step 1
COMPLETED
|
44
|
0
|
0
|
|
Step 1
NOT COMPLETED
|
58
|
0
|
0
|
|
Step 2
STARTED
|
0
|
9
|
31
|
|
Step 2
COMPLETED
|
0
|
7
|
7
|
|
Step 2
NOT COMPLETED
|
0
|
2
|
24
|
Reasons for withdrawal
| Measure |
Arm A (PCR)
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.
Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.
Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.
rituximab
cyclophosphamide
pentostatin
|
Arm B (Alemtuzumab: CR, nPR)
Patients who achieved a confirmed CR or nPR, were registered to receive Alemtuzumab (Arm B). When the patient was registered to Arm B, the drug was administered three times a week for four weeks. The dose was 30 mg per dose. A twelve-week treatment-free period had to elapse before CAMPATH-1H began following completion of PCR for Arm B patients
Alemtuzumab
|
Arm C (Alemtuzumab: PR, <PR, PD)
For those patients not achieving a CR or nPR (thus patients either achieved PR, SD, or PD), Alemtuzumab (Arm C) was administered three times a week for eighteen weeks at a dose of 30 mg TIW. For PR, SD and PD patients, the timing of CAMPATH-1H was left to the discretion of the investigator, and treatment could begin earlier but no less than two weeks and no longer than eight weeks after the completion of the last PCR course. Patients determined to have PD during treatment with PCR did not need to complete all 6 cycles of PCR to go on to Arm C, however, completing a minimum of 2 cycles was required.
Alemtuzumab
|
|---|---|---|---|
|
Step 1
Adverse Event
|
32
|
0
|
0
|
|
Step 1
Death
|
6
|
0
|
0
|
|
Step 1
Withdrawal by Subject
|
7
|
0
|
0
|
|
Step 1
Disease progression
|
2
|
0
|
0
|
|
Step 1
Alternative therapy
|
2
|
0
|
0
|
|
Step 1
Other complicating disease
|
2
|
0
|
0
|
|
Step 1
Physician Decision
|
1
|
0
|
0
|
|
Step 1
Ineligible
|
4
|
0
|
0
|
|
Step 1
Never started treatment
|
2
|
0
|
0
|
|
Step 2
Adverse Event
|
0
|
2
|
12
|
|
Step 2
Disease progression
|
0
|
0
|
5
|
|
Step 2
Death
|
0
|
0
|
3
|
|
Step 2
Withdrawal by Subject
|
0
|
0
|
2
|
|
Step 2
Physician Decision
|
0
|
0
|
1
|
|
Step 2
Ineligible
|
0
|
0
|
1
|
Baseline Characteristics
Pentostatin, Cyclophosphamide, and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL
Baseline characteristics by cohort
| Measure |
Arm A (PCR)
n=96 Participants
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.
Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.
Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.
rituximab
cyclophosphamide
pentostatin
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
92 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
|
PRIMARY outcome
Timeframe: 8 weeks after Cycle 6Population: Eligible patients who began treatment
Percent with response (CR, nPR, PR) with two-stage 90% confidence interval
Outcome measures
| Measure |
Arm A (PCR)
n=96 Participants
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.
Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.
Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.
rituximab
cyclophosphamide
pentostatin
|
|---|---|
|
Response Rate
|
55.2 percentage
Interval 46.3 to 63.9
|
PRIMARY outcome
Timeframe: 3 months post alemtuzumabPopulation: Patients who achieved a CR or nPR in Step 1 and were eligible for and began treatment on Step 2
Percent of patients who have MCR (clinical CR with flow negative and RT-PCR negative)
Outcome measures
| Measure |
Arm A (PCR)
n=9 Participants
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.
Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.
Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.
rituximab
cyclophosphamide
pentostatin
|
|---|---|
|
Molecular Complete Remission (MCR) Rate
|
44.4 percentage
Interval 16.9 to 74.9
|
SECONDARY outcome
Timeframe: Up to 5 years from registrationPopulation: Eligible patients who began treatment
OS is defined as the time from registration until death from any cause.
Outcome measures
| Measure |
Arm A (PCR)
n=96 Participants
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.
Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.
Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.
rituximab
cyclophosphamide
pentostatin
|
|---|---|
|
Overall Survival (OS)
|
27.6 months
Interval 20.2 to 42.2
|
SECONDARY outcome
Timeframe: Up to 5 years from registrationPopulation: Eligible patients who began treatment
PFS is defined as the time from registration until induction failure, institution of non-protocol therapy, relapse or death from any cause in the absence of relapse.
Outcome measures
| Measure |
Arm A (PCR)
n=96 Participants
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.
Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.
Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.
rituximab
cyclophosphamide
pentostatin
|
|---|---|
|
Progression-free Survival (PFS)
|
12.2 months
Interval 9.7 to 14.5
|
SECONDARY outcome
Timeframe: From re-registration up to 5 years (followed for response until progression)Outcome measures
| Measure |
Arm A (PCR)
n=30 Participants
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.
Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.
Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.
rituximab
cyclophosphamide
pentostatin
|
|---|---|
|
Number of Patients Who After PCR (or During PCR for PD), Only Achieve a PR, SD, or PD and Who Subsequently Convert to a Higher Response Category After Campath-1H
|
4 Participants
|
Adverse Events
Arm A (PCR)
Serious events: 88 serious events
Other events: 99 other events
Deaths: 71 deaths
Arm B (Alemtuzumab: CR, nPR)
Serious events: 8 serious events
Other events: 9 other events
Deaths: 5 deaths
Arm C (Alemtuzumab: PR, <PR, PD)
Serious events: 31 serious events
Other events: 31 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Arm A (PCR)
n=100 participants at risk
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.
Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.
Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.
rituximab cyclophosphamide pentostatin
|
Arm B (Alemtuzumab: CR, nPR)
n=9 participants at risk
Patients who achieved a confirmed CR or nPR, were registered to receive Alemtuzumab (Arm B). When the patient was registered to Arm B, the drug was administered three times a week for four weeks. The dose was 30 mg per dose. A twelve-week treatment-free period had to elapse before CAMPATH-1H began following completion of PCR for Arm B patients Alemtuzumab
|
Arm C (Alemtuzumab: PR, <PR, PD)
n=31 participants at risk
For those patients not achieving a CR or nPR (thus patients either achieved PR, SD, or PD), Alemtuzumab (Arm C) was administered three times a week for eighteen weeks at a dose of 30 mg TIW. For PR, SD and PD patients, the timing of CAMPATH-1H was left to the discretion of the investigator, and treatment could begin earlier but no less than two weeks and no longer than eight weeks after the completion of the last PCR course. Patients determined to have PD during treatment with PCR did not need to complete all 6 cycles of PCR to go on to Arm C, however, completing a minimum of 2 cycles was required.
Alemtuzumab
|
|---|---|---|---|
|
Immune system disorders
Allergic reaction
|
3.0%
3/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
CD4 decreased
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
16.0%
16/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.6%
7/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
38.0%
38/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
88.9%
8/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
90.3%
28/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
60.0%
60/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
44.4%
4/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
54.8%
17/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
34.0%
34/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.3%
3/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
41.9%
13/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Sinus bradycardia
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Cardiac-ischemia
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
C-P arrest, non-fatal, cause unknown
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
3.0%
3/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
9.0%
9/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.9%
4/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
INR increased
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Death - multiorgan failure
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
4/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
5.0%
5/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
8.0%
8/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
7/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hemorrhage-other
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
10/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
16.1%
5/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
3.0%
3/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.9%
4/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, sinus
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, skin
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, catheter
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, eye NOS
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
4.0%
4/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, sinus
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, blood
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, blood
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection-other
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Acidosis
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.0%
4/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.0%
3/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.0%
3/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.0%
6/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Ataxia
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Confusion
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-motor
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Depressed level of consciousness
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Speech impairment
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chest/thoracic pain NOS
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathic, pain
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin, pain
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
(ARDS)
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
4/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
4/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
3.0%
3/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Cystitis
|
2.0%
2/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Renal failure
|
6.0%
6/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Immune system disorders
Cytokine release syndrome
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
6.0%
6/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.0%
1/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm A (PCR)
n=100 participants at risk
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days.
Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2.
Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.
rituximab cyclophosphamide pentostatin
|
Arm B (Alemtuzumab: CR, nPR)
n=9 participants at risk
Patients who achieved a confirmed CR or nPR, were registered to receive Alemtuzumab (Arm B). When the patient was registered to Arm B, the drug was administered three times a week for four weeks. The dose was 30 mg per dose. A twelve-week treatment-free period had to elapse before CAMPATH-1H began following completion of PCR for Arm B patients Alemtuzumab
|
Arm C (Alemtuzumab: PR, <PR, PD)
n=31 participants at risk
For those patients not achieving a CR or nPR (thus patients either achieved PR, SD, or PD), Alemtuzumab (Arm C) was administered three times a week for eighteen weeks at a dose of 30 mg TIW. For PR, SD and PD patients, the timing of CAMPATH-1H was left to the discretion of the investigator, and treatment could begin earlier but no less than two weeks and no longer than eight weeks after the completion of the last PCR course. Patients determined to have PD during treatment with PCR did not need to complete all 6 cycles of PCR to go on to Arm C, however, completing a minimum of 2 cycles was required.
Alemtuzumab
|
|---|---|---|---|
|
Immune system disorders
Allergic reaction
|
18.0%
18/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
93.0%
93/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
88.9%
8/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
96.8%
30/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
58.0%
58/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
45.2%
14/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
56.0%
56/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
55.6%
5/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
74.2%
23/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
74.0%
74/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
77.8%
7/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
77.4%
24/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
6.0%
6/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
7.0%
7/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
72.0%
72/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
55.6%
5/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
67.7%
21/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
26.0%
26/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.3%
3/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
19.4%
6/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
15.0%
15/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Rigors/chills
|
31.0%
31/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
44.4%
4/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
29.0%
9/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Sweating
|
10.0%
10/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
16.1%
5/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
20.0%
20/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
19.4%
6/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.0%
7/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Injection site reaction
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
32.3%
10/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
7.0%
7/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hot flashes
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
25/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.3%
3/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
19.4%
6/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
16.0%
16/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
24.0%
24/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
11.0%
11/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
10.0%
10/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.9%
4/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
66.0%
66/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
32.3%
10/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Taste disturbance
|
14.0%
14/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
9.7%
3/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
39.0%
39/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
16.1%
5/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ unk ANC oral cavity/gums
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
15.0%
15/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
16.1%
5/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
21.0%
21/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.3%
3/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
29.0%
9/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
31.0%
31/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
19.4%
6/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Acidosis
|
14.0%
14/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
19.0%
19/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
16.1%
5/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
41.0%
41/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.3%
3/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
32.3%
10/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
29.0%
29/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
29.0%
9/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
61.0%
61/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
55.6%
5/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
41.9%
13/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.0%
6/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.0%
15/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
9.7%
3/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.0%
12/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.0%
7/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.0%
28/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.8%
8/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.0%
5/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
8.0%
8/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
9.7%
3/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
19.4%
6/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-motor
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
12.0%
12/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.9%
4/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Ocular-other
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
7.0%
7/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
9.7%
3/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
14.0%
14/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
12.9%
4/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
5.0%
5/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
15.0%
15/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
9.7%
3/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
20/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
2/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
32.3%
10/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.0%
18/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
33.3%
3/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
25.8%
8/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
1/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
1/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
6.5%
2/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Cystitis
|
5.0%
5/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
|
Immune system disorders
Cytokine release syndrome
|
5.0%
5/100 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/9 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/31 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60