Trial Outcomes & Findings for Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma (NCT NCT00690560)
NCT ID: NCT00690560
Last Updated: 2026-05-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
2 years
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
R-CHOP14 Chemotherapy
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
|
|---|---|
|
R-CHOP14 Chemotherapy
STARTED
|
30
|
|
R-CHOP14 Chemotherapy
COMPLETED
|
25
|
|
R-CHOP14 Chemotherapy
NOT COMPLETED
|
5
|
|
Follow up
STARTED
|
25
|
|
Follow up
COMPLETED
|
13
|
|
Follow up
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
R-CHOP14 Chemotherapy
n=30 Participants
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=2 Participants
|
|
Age, Continuous
|
72.7 years
STANDARD_DEVIATION 4.1 • n=2 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=2 Participants
|
|
Region of Enrollment
France
|
28 participants
n=2 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=2 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
R-CHOP14 Chemotherapy
n=30 Participants
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
|
|---|---|
|
Event-free Survival
|
76 percentage of patient
Interval 61.9 to 93.2
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
R-CHOP14 Chemotherapy
n=30 Participants
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
|
|---|---|
|
Overall Survival
|
96.3 percentage of patient
Interval 89.4 to 100.0
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
R-CHOP14 Chemotherapy
n=30 Participants
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
|
|---|---|
|
Relapse-free Survival in Responding Patients
|
82 percentage of patient
Interval 68.9 to 97.7
|
SECONDARY outcome
Timeframe: up to six monthsPopulation: Patients who completed the full course of treatment
Complete Response 60% (N=15) Partial Response 8% (N=2) Missing data 32% (N=8)
Outcome measures
| Measure |
R-CHOP14 Chemotherapy
n=25 Participants
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
|
|---|---|
|
Response Rate at the End of Treatment
MISSING DATA
|
8 Participants
|
|
Response Rate at the End of Treatment
PARTIAL RESPONSE
|
2 Participants
|
|
Response Rate at the End of Treatment
COMPLETE RESPONSE
|
15 Participants
|
Adverse Events
R-CHOP14 Chemotherapy
Serious events: 10 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R-CHOP14 Chemotherapy
n=30 participants at risk
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
|
|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Infections and infestations
SEVERE PULMONARY INFECTION
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
APLASIA
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
FEBRILE APLASIA
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
RENAL INSUFFICIENCY
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
FAINTNESS WITH LOSS OF CONSCIOUSNESS
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
THROMBOPENIA
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
MUCOSITIS
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
IMPAIRMENT OF HEALTH STATUS
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
3.3%
1/30 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOPATHY
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
FACE PARALYSIS
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
RESPIRATORY INFECTION
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
PNEUMONIA
|
3.3%
1/30 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
R-CHOP14 Chemotherapy
n=30 participants at risk
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
|
|---|---|
|
Infections and infestations
Respiratory tract infection
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Skin infection
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Number of events 2 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Facial palsy
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
5/30 • Number of events 6 • 2 years
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
3/30 • Number of events 3 • 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
60.0%
18/30 • Number of events 36 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
63.3%
19/30 • Number of events 35 • 2 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.3%
1/30 • Number of events 3 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
60.0%
18/30 • Number of events 29 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Stomatitis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
Asthenia
|
10.0%
3/30 • Number of events 3 • 2 years
|
|
General disorders
General physical health deterioration
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
General disorders
Hyperthermia
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
General disorders
Mucosal inflammation
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Immune system disorders
Iodine allergy
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Bronchitis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Conjunctivitis viral
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Herpes zoster
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Lung infection
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Oral candidiasis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Oropharyngeal candidiasis
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Nervous system disorders
Loss of consciousness
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Pollakiuria
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Renal failure
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
3.3%
1/30 • Number of events 1 • 2 years
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • 2 years
|
Additional Information
Director of Clinical Trials
Centre Antoine Lacassagne
Phone: +33 4 92 03 10 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60