Ignite Creation Date:
2024-05-05 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00722137
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2008-07-23
Brief Title:
Study of the Combination of Rituximab Cyclophosphamide Doxorubicin VELCADE and Prednisone or Rituximab Cyclophosphamide Doxorubicin Vincristine and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma
Sponsor:
Millennium Pharmaceuticals Inc
Organization:
Takeda
Study Overview
Official Title:
A Randomized Open-Label Multicenter Phase 3 Study of the Combination of Rituximab Cyclophosphamide Doxorubicin VELCADE and Prednisone VcR-CAP or Rituximab Cyclophosphamide Doxorubicin Vincristine and Prednisone R-CHOP in Patients With Newly Diagnosed Mantle Cell Lymphoma Who Are Not Eligible for a Bone Marrow Transplant
Status:
COMPLETED
Status Verified Date:
2018-06
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 is a randomized open-label multicenter prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly diagnosed mantle cell lymphoma grade II III or IV and who are ineligible to undergo bone marrow transplantation
Detailed Description:
The drug being tested in this study were combination of VcR-CAP and R-CHOP Combination of VcR-CAP and R-CHOP is being tested to treat people who had mantle cell lymphoma MCL
The study enrolled 487 patients Participants were randomly assigned by chance like flipping a coin to one of the two treatment groups in a 11 ratio
Treatment Group A VcR-CAP Treatment Group B R-CHOP
The study included a screening phase a treatment phase a short-term follow-up phase and a long-term follow-up phase The screening phase was up to 28 days 56 days for bone marrow evaluation prior to randomization
This multi-center trial was conducted worldwide The total study duration from randomization of the first patient until the last progression-free survival PFS event required for the final analysis was expected to be approximately 42 months 24 months for enrollment and 18 months for follow-up and survival follow-up every 12 weeks until death
The study enrolled 487 patients Participants were randomly assigned by chance like flipping a coin to one of the two treatment groups in a 11 ratio
Treatment Group A VcR-CAP Treatment Group B R-CHOP
The study included a screening phase a treatment phase a short-term follow-up phase and a long-term follow-up phase The screening phase was up to 28 days 56 days for bone marrow evaluation prior to randomization
This multi-center trial was conducted worldwide The total study duration from randomization of the first patient until the last progression-free survival PFS event required for the final analysis was expected to be approximately 42 months 24 months for enrollment and 18 months for follow-up and survival follow-up every 12 weeks until death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1195-3827 | OTHER | WHO | None |
| 26866138-LYM-3002CTIL | OTHER | None | None |
| 2007-005669-37 | EUDRACT_NUMBER | None | None |
| 0970313683 | REGISTRY | None | None |