Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322218
Status:
TERMINATED
Last Update Posted:
2022-01-19
First Post:
2006-05-04
Brief Title:
Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma
Sponsor:
Spectrum Pharmaceuticals Inc
Organization:
Spectrum Pharmaceuticals Inc
Study Overview
Official Title:
Phase IIIOpen-labelProspectiveTwo-armedMulticenter Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to low recruitment rate that would have led to a long study duration
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study treats patients with diffuse large B-cell lymphoma whose disease is in complete remission due to previous treatment with Cyclophosphamide Doxorubicin hydrochloride Vincristine Prednisolone- Rituximab CHOP-R Half of the patients received Zevalin and the other half receive no further anti-cancer treatment The two patient groups compared to determine if Zevalin given after CHOP-R therapy provides greater benefits than receiving no additional anti-cancer therapy after CHOP-R
Detailed Description:
The objectives of this study were to evaluate the efficacy and safety of the Zevalin study regimen compared with observation alone in patients with complete remission CR or CRu after first-line CHOP-R the study was to include patients 60-years-of-age or older with histologically confirmed Ann Arbor stage II III or IV diffuse large B-cell lymphoma
End Points
Primary endpoint Overall survival OS Secondary endpoints Disease-free survival DFS health-related quality of life HRQL as assessed by the patient using standard questionnaires
Number of Patients
A total of 400 patients 200 per arm were planned to be enrolled
- In fact 68 randomized patients full analysis set FAS were analysed 34 patients per each arm The per-protocol set PPS 65 patients comprised 33 patients allocated to the Zevalin arm and 32 patients allocated to the observation control arm
Study Treatment
The combination regimen with rituximab was designed in 2 steps as follows
Day 1 Initial administration of 250 mgm2 rituximab followed immediately by administration of 185 megabecquerel MBq 5 millicurie mCi of 111In-ibritumomab tiuxetan the latter one only in centers where biodistribution imaging or dosimetry was compulsory according to local law In centers where biodistribution imaging or dosimetry had not been required the first rituximab infusion was given alone
Day 7-9 Rituximab 250 mgm2 followed immediately by 90Y-ibritumomab tiuxetan 148 megabecquerelkilograms MBqkg 04 millicurie kilogram mCikg maximum dose 1184 MBq given as a slow intravenous IV push over 10 minutes Two treatment days one week apart followed by a 12-week safety period
Duration of Patient Participation
Due to the sequential design the total duration of this study was not fixed Originally the study was planned in a randomized parallel-group group sequential design
Objective
The primary objective of this study was an inferential comparison between the 2 randomized groups in terms of overall survival using a group sequential triangular test since the study was prematurely terminated the pre-planned group-sequential nature of the study design was not applicable statistical analyses Actually the prominent efficacy variables for the OS and DFS were analysed in the FAS identical to the safety analysis set and PPS using Kaplan Meier estimates by treatment group
Study Design
This study was designed as a prospective multi-center open label randomized two-armed group-sequential Phase III study The study was planned to consist of 2 stages an interventional Stage 1 with ScreeningBaseline treatment safety and follow-up periods and a non-interventional Stage 2 consisting of a long-term follow-up period until completion of a median observation period of 5 years This second stage of the study was to be started only if superiority of the Zevalin study regimen could be demonstrated in the preceding Stage 1
PharmacokineticsPharmacodynamic results Not applicable
Extent of exposure
All 34 patients randomized to the Zevalin arm were given 2 rituximab infusionswith a median dose of 4250 mg at each of the 2 infusion time pointsThree patients underwent radioimaging studiesdosimetry and therefore were administered 111In-ibritumomab tiuxetan at Day 1 All but 1 patient received an infusion with 90Y-ibritumomab tiuxetan following the second infusion of rituximab The mean dose ranged from 7659 -11970 MBq
End Points
Primary endpoint Overall survival OS Secondary endpoints Disease-free survival DFS health-related quality of life HRQL as assessed by the patient using standard questionnaires
Number of Patients
A total of 400 patients 200 per arm were planned to be enrolled
- In fact 68 randomized patients full analysis set FAS were analysed 34 patients per each arm The per-protocol set PPS 65 patients comprised 33 patients allocated to the Zevalin arm and 32 patients allocated to the observation control arm
Study Treatment
The combination regimen with rituximab was designed in 2 steps as follows
Day 1 Initial administration of 250 mgm2 rituximab followed immediately by administration of 185 megabecquerel MBq 5 millicurie mCi of 111In-ibritumomab tiuxetan the latter one only in centers where biodistribution imaging or dosimetry was compulsory according to local law In centers where biodistribution imaging or dosimetry had not been required the first rituximab infusion was given alone
Day 7-9 Rituximab 250 mgm2 followed immediately by 90Y-ibritumomab tiuxetan 148 megabecquerelkilograms MBqkg 04 millicurie kilogram mCikg maximum dose 1184 MBq given as a slow intravenous IV push over 10 minutes Two treatment days one week apart followed by a 12-week safety period
Duration of Patient Participation
Due to the sequential design the total duration of this study was not fixed Originally the study was planned in a randomized parallel-group group sequential design
Objective
The primary objective of this study was an inferential comparison between the 2 randomized groups in terms of overall survival using a group sequential triangular test since the study was prematurely terminated the pre-planned group-sequential nature of the study design was not applicable statistical analyses Actually the prominent efficacy variables for the OS and DFS were analysed in the FAS identical to the safety analysis set and PPS using Kaplan Meier estimates by treatment group
Study Design
This study was designed as a prospective multi-center open label randomized two-armed group-sequential Phase III study The study was planned to consist of 2 stages an interventional Stage 1 with ScreeningBaseline treatment safety and follow-up periods and a non-interventional Stage 2 consisting of a long-term follow-up period until completion of a median observation period of 5 years This second stage of the study was to be started only if superiority of the Zevalin study regimen could be demonstrated in the preceding Stage 1
PharmacokineticsPharmacodynamic results Not applicable
Extent of exposure
All 34 patients randomized to the Zevalin arm were given 2 rituximab infusionswith a median dose of 4250 mg at each of the 2 infusion time pointsThree patients underwent radioimaging studiesdosimetry and therefore were administered 111In-ibritumomab tiuxetan at Day 1 All but 1 patient received an infusion with 90Y-ibritumomab tiuxetan following the second infusion of rituximab The mean dose ranged from 7659 -11970 MBq
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None