Trial Outcomes & Findings for Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma (NCT NCT00389818)
NCT ID: NCT00389818
Last Updated: 2018-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
DR-COP
Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
DR-COP
n=40 Participants
Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuationOutcome measures
| Measure |
DR-COP
n=40 Participants
Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
|
|---|---|
|
Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .
|
0.475 proportion of patients
Interval 0.315 to 0.639
|
PRIMARY outcome
Timeframe: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuationOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuationOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, after cycles 4 and 6, 1 month after treatment discontinuationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At any time through the third year after treatment discontinuationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year post-treatmentOutcome measures
Outcome data not reported
Adverse Events
DR-COP
Serious events: 26 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DR-COP
n=40 participants at risk
Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
2/40 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
7.5%
3/40 • Number of events 4
|
|
Eye disorders
Optic nerve disorder
|
2.5%
1/40 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Ileal obstruction
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Ileal perforation
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • Number of events 3
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
3/40 • Number of events 5
|
|
General disorders
Death
|
30.0%
12/40 • Number of events 12
|
|
General disorders
Fever
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Pain
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Cather related infection
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
Lung infection
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Skin infection
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
15.0%
6/40 • Number of events 9
|
|
Investigations
Platelet count decreased
|
7.5%
3/40 • Number of events 4
|
|
Investigations
Weight loss
|
5.0%
2/40 • Number of events 3
|
|
Investigations
White blood cell decreased
|
7.5%
3/40 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
2/40 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • Number of events 2
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Leukoencephalopathy
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
2/40 • Number of events 5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Seizure
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Delirium
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Renal and urinary disorders, other
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
4/40 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.5%
3/40 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
DR-COP
n=40 participants at risk
Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
32.5%
13/40 • Number of events 19
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
5/40 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
32.5%
13/40 • Number of events 19
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
12/40 • Number of events 17
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders, other
|
7.5%
3/40 • Number of events 6
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
2/40 • Number of events 2
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders, other
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
27.5%
11/40 • Number of events 14
|
|
Gastrointestinal disorders
Diarrhea
|
17.5%
7/40 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia
|
7.5%
3/40 • Number of events 3
|
|
Gastrointestinal disorders
Gastric ulcer
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis, oral
|
15.0%
6/40 • Number of events 10
|
|
General disorders
Chills
|
15.0%
6/40 • Number of events 6
|
|
General disorders
Edema, limbs
|
12.5%
5/40 • Number of events 6
|
|
General disorders
Fatigue
|
35.0%
14/40 • Number of events 19
|
|
General disorders
Fever
|
20.0%
8/40 • Number of events 10
|
|
General disorders
Non-cardiac chest pain
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Pain
|
7.5%
3/40 • Number of events 4
|
|
Infections and infestations
Infections and investigations, other
|
10.0%
4/40 • Number of events 4
|
|
Infections and infestations
Mucosal infections
|
12.5%
5/40 • Number of events 5
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
7.5%
3/40 • Number of events 4
|
|
Investigations
Alkaline phosphatase increased
|
7.5%
3/40 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
7.5%
3/40 • Number of events 3
|
|
Investigations
Lymphocyte count decreased
|
15.0%
6/40 • Number of events 18
|
|
Investigations
Neutrophil count decreased
|
55.0%
22/40 • Number of events 54
|
|
Investigations
Platelet count decreased
|
7.5%
3/40 • Number of events 4
|
|
Investigations
Weight gain
|
5.0%
2/40 • Number of events 3
|
|
Investigations
Weight loss
|
17.5%
7/40 • Number of events 10
|
|
Investigations
White blood cell decreased
|
25.0%
10/40 • Number of events 30
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
6/40 • Number of events 8
|
|
Metabolism and nutrition disorders
Dehydration
|
7.5%
3/40 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
2/40 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.5%
3/40 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
3/40 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
5/40 • Number of events 6
|
|
Nervous system disorders
Headache
|
20.0%
8/40 • Number of events 13
|
|
Nervous system disorders
Leukoencephalopathy
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Memory impairment
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.5%
3/40 • Number of events 4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
32.5%
13/40 • Number of events 19
|
|
Psychiatric disorders
Anxiety
|
7.5%
3/40 • Number of events 3
|
|
Psychiatric disorders
Depression
|
5.0%
2/40 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
12.5%
5/40 • Number of events 5
|
|
Renal and urinary disorders
Urinary frequency
|
5.0%
2/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.5%
7/40 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.5%
3/40 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
12.5%
5/40 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
5/40 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
4/40 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
2/40 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
12.5%
5/40 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
4/40 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders, other
|
10.0%
4/40 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.0%
4/40 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place