Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337519
Status:
UNKNOWN
Last Update Posted:
2009-01-29
First Post:
2006-06-15
Brief Title:
Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Chemo-Immunotherapy With Allogeneic Blood Stem Cell Transplantation in Patients With Chronic Lymphocytic Leukemia Study 02
Status:
UNKNOWN
Status Verified Date:
2009-01
Last Known Status:
ACTIVE_NOT_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:
Patients with advanced chronic lymphocytic leukemia CLL have a poor long-term prognosis Allogeneic stem cell transplantation SCT in patients with CLL has only rarely been performed in the past because the clinical outcome after myeloablative conditioning was poor mainly due to the high treatment-related mortality However long-term disease-free survival after allogeneic SCT has been reported Recently it has been demonstrated by our group and others that non-relapse mortality can be reduced significantly with the use of reduced-intensity conditioning regimens Yet graft versus host disease GVHD remains an important problem in this setting
Alemtuzumab is an effective drug for the treatment of patients with advanced CLL and has been successfully applied for GVHD-prophylaxis in the setting of myeloablative and reduced-intensity conditioning regimens The goal of the present study is to evaluate the role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for allogeneic SCT in patients with advanced CLL
Alemtuzumab is an effective drug for the treatment of patients with advanced CLL and has been successfully applied for GVHD-prophylaxis in the setting of myeloablative and reduced-intensity conditioning regimens The goal of the present study is to evaluate the role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for allogeneic SCT in patients with advanced CLL
Detailed Description:
Patients with relapsed or refractory CLL who are eligible for the study receive a cytoreductive therapy until SCT Irrespective to the formal response patients proceed to allogeneic SCT after fludarabine-based reduced-intensity conditioning The use of granulocyte colony-stimulating factor G-CSF-mobilized peripheral blood stem cells 3 x 10E6 CD34 cellskg is recommended but bone marrow 1 x 10E8 MNCkg is accepted GVHD-prophylaxis is based on cyclosporine A adapted to blood levels 150 to 200 ngmL over a period of three months In Phase I of the study alemtuzumab has been applied as part of the conditioning regimen until day 5 In Phase II alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14 and after Amendment II in September 2006 scheduled for day 28 Furthermore methotrexate is given on days 1 3 6 and 11 at a projected cumulative dose of 45 mgm2 Subsequent immunosuppressive therapy depends on the occurrence of GvHD the development of chimerism and residual disease Patients with relapsing or residual disease minimal residual disease excluded who do not suffer from GvHD should receive donor lymphocytes in increasing dosages The initial dose is 1 x 105kg T-cells in unrelated donors and 1 x 106kg in matched related donors If no GvHD develops within 6-8 weeks the next higher dosage is applied
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 |
|---|---|---|---|
| DJCLS-R0301 | None | None | None |