Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922567
Status:
RECRUITING
Last Update Posted:
2022-11-07
First Post:
2021-06-05
Brief Title:
Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP L-CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2022-10
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:
This study aims to compare the efficacy and safety of lenalidomide plus CHOP L-CHOP versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma PTCL
Detailed Description:
This is a randomized multi-center open-label study to compare efficacy and safety of L-CHOP with standard CHOP regimen in patients with previously untreated PTCL Study subjects are patients with histologically proven PTCL Patients are randomized 11 to receive either cyclophosphamide doxorubicin vincristine and prednisone CHOP administered in 3 week cycles for 6 cycles or Lenalidomide plus CHOP L-CHOP administered in 3 week cycles for 6 cycles In the L-CHOP arm Lenalidomide will be administered at a dose of 25mg po on day 1-10 every 3 weeks This study is divided into three phases screening phase treatment phase and follow-up phase Patients will receive study drugs for up to 6 cycles or until unacceptable toxicity will develop or progression or voluntary with drawl Adverse event of every treatment cycle will be recorded Therapy efficacy will be evaluated after finishing 3 cycles and finishing 6 cycles therapy Patients will be followed until disease progression died or 3 years from the last patient randomized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None