Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT01283386 |
Date of registration:
|
18/01/2011 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
|
Scientific title:
|
Prospective Randomized Study to Compare Efficacy and Safety of RFC-Lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Unfavorable Somatic Status |
Date of first enrolment:
|
April 27, 2011 |
Target sample size:
|
26 |
Recruitment status: |
Terminated |
URL:
|
https://clinicaltrials.gov/show/NCT01283386 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
Phase:
|
Phase 4
|
|
Countries of recruitment
|
Russian Federation
| | | | | | | |
Contacts
|
Name:
|
Clinical Trials |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Hoffmann-La Roche |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Adult patients, 60-70 or >70 years of age
- Cumulative Illness Rating Scale (CIRS) comorbidity score >/=7 if patient is 60-70
years old
- Previously untreated B-cell chronic lymphocytic leukemia
- Binet stage B, C or A with progression
- ECOG performance status 0-2
Exclusion Criteria:
- Small-cell lymphoma
- Autoimmune hemolytic anemia
- Concomitant malignant disease during enrollment, except for basal cell carcinoma of
the skin
- Chemotherapy for concomitant malignant disease within 12 months prior to study
enrollment
- Richter's syndrome
Age minimum:
60 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Lymphocytic Leukemia, Chronic
|
Intervention(s)
|
Drug: Chlorambucil
|
Drug: Fludarabine
|
Drug: Rituximab
|
Drug: Cyclophosphamide
|
Primary Outcome(s)
|
Percentage of Participants With Disease Progression
[Time Frame: Up to approximately 5 years]
|
Duration of Response
[Time Frame: Up to approximately 5 years]
|
Percentage of Participants With Complete Remission
[Time Frame: Up to approximately 5 years]
|
Progression-free Survival
[Time Frame: Up to approximately 5 years]
|
Event-free Survival
[Time Frame: Up to approximately 5 years]
|
Percentage of Participants With Phenotypic Remission
[Time Frame: Up to approximately 5 years]
|
Overall Survival
[Time Frame: Up to approximately 5 years]
|
Percentage of Participants With Adverse Events (AEs) and Serious AEs
[Time Frame: Up to approximately 5 years]
|
Percentage of Participants With Stable Disease
[Time Frame: Up to approximately 5 years]
|
Percentage of Participants With Partial Remission
[Time Frame: Up to approximately 5 years]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
|