Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336206
Status:
UNKNOWN
Last Update Posted:
2006-07-25
First Post:
2006-06-12
Brief Title:
Low Dose Alemtuzumab for Consolidation and Maintenance of Patients With B-Cell Chronic Lymphocytic Leukemia
Sponsor:
Tawam Hospital
Organization:
Tawam Hospital
Study Overview
Official Title:
Subcutaneous Injection Low Dose Alemtuzumab for Consolidation and Maintenance of Patients in Clinical Response After Having Achieved Partial or Complete Remission After 1st or 2nd Line Anti-Tumor Therapy for B-Cell CLL
Status:
UNKNOWN
Status Verified Date:
2006-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to evaluate if the treatment with Alemtuzumab after I or II line chemotherapy administered for 6 weeks followed by 4 months maintenance treatment compared to a control group can reduce disease activityresidual disease and thereby delay the reoccurrence of the CLL disease
Detailed Description:
Fludarabine F alone or in combination with cyclophosphamide FC is not a curative treatment for patients with CLL all patients will eventually relapse Therefore there is a medical need to look for consolidation followed by maintenance therapies which are able to prolong response duration or which can shift anti-tumor therapy induced partial remissions to complete remissions or eradicate minimal residual disease in complete - but still PCR-positive - responders
There is no standard consolidation therapy available at the moment and the role of consolidation in CLL has recently been acknowledged as a research field of major importance in B-CLL Schering global advisory board meeting Lisbon Nov 2005 Possible treatment options are high-dose chemotherapy followed by autologous stem cell transplantation the role of which however remains uncertain with lack of worldwide consensus or monoclonal antibody therapy against antigens expressed by CLL cells Alemtuzumab is directed against the CD52-antigen which is present in high density on CLL cells and may therefore be most suitable for treatment of residual disease
Alemtuzumab has shown significant remission rates in patients with fludarabine refractory CLL and sub analysis revealed a very high effectiveness of the antibody in clearing CLL cells from peripheral blood and bone marrow These findings suggest that Alemtuzumab might be an ideal candidate to eliminate minimal residual disease in a post-remission treatment after anti-tumor therapy and to be used as maintenance therapy The efficacy of Alemtuzumab as consolidation therapy in CLL can easily be measured There is evidence from several studies that treatment with Alemtuzumab does not have a negative impact on stem cell mobilization Therefore autologous stem cell transplantation still remains as a further treatment option for those patients who still have detectable disease after primary cytoreduction followed by consolidation therapy with Alemtuzumab
Side effects of sc Alemtuzumab in heavily pretreated patients with advanced disease are tolerable and manageable Data have suggested that the safety profile of this antibody is even more favorable in less pretreated patients and the GCLLSG study suggests that a wash-out period of more than 8 weeks and possibly also a lower dose is necessary to avoid severe infectious problems Campath administration started after a 2-month wash out period after Fludarabine was shown to be feasible and good tolerated Based on the collective data obtained from other pilot or phase II studies a subcutaneous consolidation dose of 30 mg once weekly in previously treated and untreated CLL patients after an induction with Fludarabine combination seems to be a safe and effective dose
The proposed study aims to evaluate the efficacy of low dose treatment with Alemtuzumab with regard to the following questions Does consolidation therapy with low dose Alemtuzumab result in a prolonged time to disease progression in comparison to patients who do not receive further treatment Is it possible to turn a PR into a CR Does maintenance therapy with Alemtuzumab translate into a progression-free survival benefit compared to patients with no further treatment How is the safety profile in patients treated with low dose Alemtuzumab as MRD elimination and as maintenance therapy
There is no standard consolidation therapy available at the moment and the role of consolidation in CLL has recently been acknowledged as a research field of major importance in B-CLL Schering global advisory board meeting Lisbon Nov 2005 Possible treatment options are high-dose chemotherapy followed by autologous stem cell transplantation the role of which however remains uncertain with lack of worldwide consensus or monoclonal antibody therapy against antigens expressed by CLL cells Alemtuzumab is directed against the CD52-antigen which is present in high density on CLL cells and may therefore be most suitable for treatment of residual disease
Alemtuzumab has shown significant remission rates in patients with fludarabine refractory CLL and sub analysis revealed a very high effectiveness of the antibody in clearing CLL cells from peripheral blood and bone marrow These findings suggest that Alemtuzumab might be an ideal candidate to eliminate minimal residual disease in a post-remission treatment after anti-tumor therapy and to be used as maintenance therapy The efficacy of Alemtuzumab as consolidation therapy in CLL can easily be measured There is evidence from several studies that treatment with Alemtuzumab does not have a negative impact on stem cell mobilization Therefore autologous stem cell transplantation still remains as a further treatment option for those patients who still have detectable disease after primary cytoreduction followed by consolidation therapy with Alemtuzumab
Side effects of sc Alemtuzumab in heavily pretreated patients with advanced disease are tolerable and manageable Data have suggested that the safety profile of this antibody is even more favorable in less pretreated patients and the GCLLSG study suggests that a wash-out period of more than 8 weeks and possibly also a lower dose is necessary to avoid severe infectious problems Campath administration started after a 2-month wash out period after Fludarabine was shown to be feasible and good tolerated Based on the collective data obtained from other pilot or phase II studies a subcutaneous consolidation dose of 30 mg once weekly in previously treated and untreated CLL patients after an induction with Fludarabine combination seems to be a safe and effective dose
The proposed study aims to evaluate the efficacy of low dose treatment with Alemtuzumab with regard to the following questions Does consolidation therapy with low dose Alemtuzumab result in a prolonged time to disease progression in comparison to patients who do not receive further treatment Is it possible to turn a PR into a CR Does maintenance therapy with Alemtuzumab translate into a progression-free survival benefit compared to patients with no further treatment How is the safety profile in patients treated with low dose Alemtuzumab as MRD elimination and as maintenance therapy
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