Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462332
Status:
COMPLETED
Last Update Posted:
2013-09-06
First Post:
2007-04-18
Brief Title:
Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia
Sponsor:
Gruppo Italiano Malattie EMatologiche dellAdulto
Organization:
Gruppo Italiano Malattie EMatologiche dellAdulto
Study Overview
Official Title:
Phase II Pilot Trial to Evaluate the Efficacy of a Combined Therapy Approach for Young CLL Patients With Advanced and Progressive Disease Stratified According to the Biological Prognostic Features
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
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:
LLC0405
Brief Summary:
RATIONALE Drugs used in chemotherapy such as fludarabine and cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as alemtuzumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them A peripheral stem cell transplant using stem cells from the patient or a donor may replace the patients immune cells that were destroyed by chemotherapy
PURPOSE This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia
PURPOSE This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of induction therapy comprising fludarabine phosphate with either alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplantation or alemtuzumab in patients with advanced or progressive chronic lymphocytic leukemia
Secondary
Determine the toxicity of this regimen in these patients
Determine the length of survival event-free survival and disease-free survival of patients treated with this regimen
Evaluate the relationship between different clinical and biological disease characteristics therapeutic response and survival
OUTLINE This is a pilot multicenter study Patients are stratified according to biological risk profile high vs low risk
Group 1 high-risk patients
Induction therapy Patients receive fludarabine phosphate IV and alemtuzumab IV on days 1-3 Treatment repeats for 4 courses
Patients with no response no good clinical partial response steady disease or progressive disease after induction therapy are removed from the study Other patients proceed to post-induction therapy based on response to induction therapy
Post-induction therapy
Complete clinical cytometric and molecular response Patients undergo peripheral blood stem cell PBSC mobilization with cytarabine IV twice daily on days 1-3 and filgrastim G-CSF followed by no further therapy
Response to induction therapy and evidence of residual disease complete clinical and cytometric response with molecular evidence of disease complete clinical response only or good clinical partial response Patients without an HLA familial matched donor undergo PBSC mobilization with cytarabine IV twice daily on days 1-3 and G-CSF Patients with sufficient harvested autologous PBSCs undergo autologous PBSC transplantation with BEAM conditioning regimen carmustine etoposide cytarabine and melphalan Patients without sufficient harvested
PBSCs receive alemtuzumab subcutaneously SC weekly for 6 weeks Patients who do not achieve molecular remission after 6 weeks of alemtuzumab receive 6 additional weeks of treatment Patients with an HLA familial matched
undergo reduced-intensity allogeneic stem cell transplantation with cyclophosphamide thiotepa and fludarabine phosphate as conditioning regimen
Group 2 low-risk patients
Induction therapy Patients receive fludarabine phosphate and cyclophosphamide on days 1-3 Treatment repeats every month for 4 courses Patients achieving at least a partial response receive 2 additional courses
Patients achieving complete clinical response with cytometric and molecular response complete clinical response with a cytometric response or complete clinical response after completion of induction therapy ie partial response or greater receive no further treatment Patients with no response or disease progression proceed to post-induction therapy
Post-induction therapy Patients receive alemtuzumab SC weekly for 6 weeks Patients who do not achieve complete remission after 6 weeks of alemtuzumab receive 6 additional weeks of treatment
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Primary
Determine the antitumor activity of induction therapy comprising fludarabine phosphate with either alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplantation or alemtuzumab in patients with advanced or progressive chronic lymphocytic leukemia
Secondary
Determine the toxicity of this regimen in these patients
Determine the length of survival event-free survival and disease-free survival of patients treated with this regimen
Evaluate the relationship between different clinical and biological disease characteristics therapeutic response and survival
OUTLINE This is a pilot multicenter study Patients are stratified according to biological risk profile high vs low risk
Group 1 high-risk patients
Induction therapy Patients receive fludarabine phosphate IV and alemtuzumab IV on days 1-3 Treatment repeats for 4 courses
Patients with no response no good clinical partial response steady disease or progressive disease after induction therapy are removed from the study Other patients proceed to post-induction therapy based on response to induction therapy
Post-induction therapy
Complete clinical cytometric and molecular response Patients undergo peripheral blood stem cell PBSC mobilization with cytarabine IV twice daily on days 1-3 and filgrastim G-CSF followed by no further therapy
Response to induction therapy and evidence of residual disease complete clinical and cytometric response with molecular evidence of disease complete clinical response only or good clinical partial response Patients without an HLA familial matched donor undergo PBSC mobilization with cytarabine IV twice daily on days 1-3 and G-CSF Patients with sufficient harvested autologous PBSCs undergo autologous PBSC transplantation with BEAM conditioning regimen carmustine etoposide cytarabine and melphalan Patients without sufficient harvested
PBSCs receive alemtuzumab subcutaneously SC weekly for 6 weeks Patients who do not achieve molecular remission after 6 weeks of alemtuzumab receive 6 additional weeks of treatment Patients with an HLA familial matched
undergo reduced-intensity allogeneic stem cell transplantation with cyclophosphamide thiotepa and fludarabine phosphate as conditioning regimen
Group 2 low-risk patients
Induction therapy Patients receive fludarabine phosphate and cyclophosphamide on days 1-3 Treatment repeats every month for 4 courses Patients achieving at least a partial response receive 2 additional courses
Patients achieving complete clinical response with cytometric and molecular response complete clinical response with a cytometric response or complete clinical response after completion of induction therapy ie partial response or greater receive no further treatment Patients with no response or disease progression proceed to post-induction therapy
Post-induction therapy Patients receive alemtuzumab SC weekly for 6 weeks Patients who do not achieve complete remission after 6 weeks of alemtuzumab receive 6 additional weeks of treatment
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
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 |
|---|---|---|---|
| 2005-002476-15 | EUDRACT_NUMBER | GIMEMA | None |
| LLC0405 | OTHER | None | None |