Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309881
Status:
COMPLETED
Last Update Posted:
2016-10-03
First Post:
2006-03-29
Brief Title:
Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia CLL That Did Not Respond to Fludarabine CLL With Autoimmune Haemolytic Anemia AIHA or Richters Transformation RT
Sponsor:
German CLL Study Group
Organization:
German CLL Study Group
Study Overview
Official Title:
CHOP Plus Rituximab CHOP-R in Fludarabine Refractory Chronic Lymphocytic Leukemia CLL or CLL With Autoimmune Haemolytic Anemia AIHA or Richters Transformation RT
Status:
COMPLETED
Status Verified Date:
2016-09
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy 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 rituximab 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 Giving more than one drug combination chemotherapy together with rituximab may kill more cancer cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with chronic lymphocytic leukemia CLL that has not responded to fludarabine closed to entry as of 102006 CLL with autoimmune hemolytic anemia or Richter transformation
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with chronic lymphocytic leukemia CLL that has not responded to fludarabine closed to entry as of 102006 CLL with autoimmune hemolytic anemia or Richter transformation
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy in terms of the rate and quality of remission of chemotherapy comprising cyclophosphamide doxorubicin hydrochloride vincristine prednisone and rituximab CHOP-R in patients with fludarabine-refractory chronic lymphocytic leukemia CLL closed to accrual as of 102006 CLL with autoimmune hemolytic anemia or Richter transformation
Determine the incidence of infection in patients on CHOP-R regimen
Secondary
Determine the toxicity of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
OUTLINE This is a prospective multicenter study Patients are stratified according to disease chronic lymphocytic leukemia CLL closed to accrual as of 102006 vs CLL with autoimmune hemolytic anemia vs Richter transformation
Patients receive cyclophosphamide IV doxorubicin hydrochloride IV and vincristine IV on day 1 and oral prednisone on days 1-5 Patients also receive rituximab IV on day 1 of the second course and each subsequent course Treatment repeats every 21 days for up to 6 for patients with CLL or 8 for patients with Richters transformation courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study
Primary
Determine the efficacy in terms of the rate and quality of remission of chemotherapy comprising cyclophosphamide doxorubicin hydrochloride vincristine prednisone and rituximab CHOP-R in patients with fludarabine-refractory chronic lymphocytic leukemia CLL closed to accrual as of 102006 CLL with autoimmune hemolytic anemia or Richter transformation
Determine the incidence of infection in patients on CHOP-R regimen
Secondary
Determine the toxicity of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
OUTLINE This is a prospective multicenter study Patients are stratified according to disease chronic lymphocytic leukemia CLL closed to accrual as of 102006 vs CLL with autoimmune hemolytic anemia vs Richter transformation
Patients receive cyclophosphamide IV doxorubicin hydrochloride IV and vincristine IV on day 1 and oral prednisone on days 1-5 Patients also receive rituximab IV on day 1 of the second course and each subsequent course Treatment repeats every 21 days for up to 6 for patients with CLL or 8 for patients with Richters transformation courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 75 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 |
|---|---|---|---|
| MEDAC-GCLLSG-CLL2G | None | None | None |
| EU-20549 | None | None | None |
| GCLLSG-423 | None | None | None |