Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504491
Status:
WITHDRAWN
Last Update Posted:
2011-12-30
First Post:
2007-07-19
Brief Title:
R-CHOP and Alemtuzumab in Patients With Chronic Lymphocytic Leukemia
Sponsor:
CABYC
Organization:
CABYC
Study Overview
Official Title:
Rescue Treatment With Rituximab-CHOP Therapy and Alemtuzumab R-CHOP-A in Refractory or Recidivant Patients With Chronic Lymphocytic Leukemia After Purine-analogous Treatment
Status:
WITHDRAWN
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IMP new owner decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R-CHOP
Brief Summary:
Since there is no standard rescue therapy for refractory CLL or relapsed to the purine analogous our target is to carry out a rescue therapy combining several chemotherapy agents CHOP adding the synergistic effect of Rituximab in order to act against tumour-like CLL forms with assessable size lymph nodes Afterwards based in other studies we shall study the role of Alemtuzumab as drug for consolidation or improvement of responses obtained with the initial therapy CHOP-R acting by cleaning from peripheral blood and bone marrow the CLL lymphocytes that may have had remain as residual after chemotherapy induction therapy More precisely the addition of Alemtuzumab as maintenance treatment would increase the complete responses with negative residual disease number and may prolong the duration of the response For this it is necessary to have not only an adequate and rigorous clinical follow-up but also biological ie being able to analyze minimal residual disease by molecular biology techniques This is the reason of writing this phase II clinical trial protocol
Detailed Description:
OBJECTIVES
The objectives of this clinical trial are the following
Main objective of the study Overall response rate obtained after R-CHOP regime followed by Alemtuzumab consolidation as second line therapy
Secondary objectives
Determine the molecular complete response rate after R-CHOP regimen
Determine the efficacy of Alemtuzumab in response improvement after R-CHOP regimen conversion of PR to CR and of MRD to MRD-
Applicability toxicity profile of Alemtuzumab consolidation therapy
As additional objectives will be considered
1 Prognostic value of several biological variables ZAP-70 and cytogenetics having influence on the response
2 Response duration
3 Progression free survival
4 Overall survival
The objectives of this clinical trial are the following
Main objective of the study Overall response rate obtained after R-CHOP regime followed by Alemtuzumab consolidation as second line therapy
Secondary objectives
Determine the molecular complete response rate after R-CHOP regimen
Determine the efficacy of Alemtuzumab in response improvement after R-CHOP regimen conversion of PR to CR and of MRD to MRD-
Applicability toxicity profile of Alemtuzumab consolidation therapy
As additional objectives will be considered
1 Prognostic value of several biological variables ZAP-70 and cytogenetics having influence on the response
2 Response duration
3 Progression free survival
4 Overall survival
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-003097-26 | EUDRACT_NUMBER | None | None |