Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131313
Status:
UNKNOWN
Last Update Posted:
2005-08-18
First Post:
2005-08-16
Brief Title:
Efficacy and Safety of Nipent Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia
Sponsor:
East Valley Hematology and Oncology Medical Group
Organization:
East Valley Hematology and Oncology Medical Group
Study Overview
Official Title:
A Multicenter Open-Label Study of Nipent Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
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:
This research study measures the safety and efficacy of the combination of three drugs that are approved Nipent Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia CLL These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA
Detailed Description:
Chronic Lymphocytic Leukemia CLL is the most common form of adult leukemia in the US Recent experience with Nipent in conjunction with Rituxan has shown that this combination is well tolerated and is clinically promising It is expected that the addition of Cytoxan in patients with previously untreated CLL and patients who have relapsed or failed prior therapy may benefit from combined therapy using Nipent Cytoxan and Rituxan It is unknown how the addition of Cytoxan will affect the toxicity profile of the Rituxan and Nipent regimen however patients will be monitored for toxicities It is expected that bone marrow toxicities will not increase to unreasonable levels
The primary objective of the study is to determine the overall efficacy response rate following treatment with Nipent Cytoxan and Rituxan of patients with previously untreated or treated CLL The secondary objectives of the study are to determine the duration of response time to progression time to treatment failure and to evaluate the toxicity of this combination of drugs and the incidence and severity of adverse events
The primary objective of the study is to determine the overall efficacy response rate following treatment with Nipent Cytoxan and Rituxan of patients with previously untreated or treated CLL The secondary objectives of the study are to determine the duration of response time to progression time to treatment failure and to evaluate the toxicity of this combination of drugs and the incidence and severity of adverse events
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 |
|---|---|---|---|
| NIP-02-005 | None | None | None |