| Protocol #: |
S2421 |
| Priority #: |
2 |
| Title: |
A Randomized Phase II Study of Pirtobrutinib plus R-CHOP vs. R-CHOP for Patients with Previously Untreated Richter Transformation (RT) |
| Disease Committee: |
Leukemia
|
| SCs: Drs. |
Mazyar Shadman, MD, MPH. and Alexey Danilov, MD |
| Notes: |
06/14/2024: LYSC review call scheduled.
04/29/2024: LKSC submittal, pending May review.
04/24/2024: Pharma kick-off call.
03/26/2024: F&F call.
03/12/2024: PROCore Review & recommendations submitted.
03/05/2024: PRO proposal submitted for March review.
03/05/2024: Risk Assessment.
02/09/2024: Internal Study Team Meeting.
01/22/2024: Triage approval letter received.
04/24/2024: Kick-off call with Eli Lilly
04/29/2024: Submitted to LKSC
05/06/2024: Notified of 6/14 LYSC review, reached out to clarify that it should be LKSC, pending response.
|
I. CAPSULE SUMMARY:
It is the responsibility of the Study Coordinator to make sure that all capsule summary form requirements are completed prior to submission of the summary for executive review. (See Capsule Summary Template for requirements)
|
| Approval Date |
2024-01-08 |
| Comments |
|
II. PROTOCOL DEVELOPMENT:
All of these steps must be completed before a protocol can be activated.
|
a. Letter of Intent:
Phase II w/NCI-supplied drug OR go to II.c
Applicable: Yes
|
| Primary Committee's Review |
Submission |
Approval
|
| |
|
|
| Comments |
|
b. Concept Submission Form:
Phase III only
Applicable: Yes
|
| Review |
Submission |
Approval |
| |
|
|
| Comments |
|
c. Initial Protocol Draft/Review:
This process may be repeated until the final protocol is drafted.
|
| Protocol Review |
Date/N/A |
| Study Coordinators/Committee Chair(s) |
|
| Statistical Center |
|
| Other Committee SCs (if needed) |
v |
| Drug Company (if needed) |
|
| Other Reviews |
|
| Draft Forms Inserted |
|
| Ops Consistency Check |
|
| NCI Protocol Submission Worksheet |
|
| PRC Review |
|
|
Intergroup CTSU:
QARC:
RPC:
|
| Comments |
|
| d. Final Protocol Draft/Review: |
| Protocol Review |
Date/N/A |
| Study Coordinators/Committee Chair(s) |
|
| Statistical Center |
|
| Others |
|
CTEP/DCP
(copy for IND and contracts, if needed) |
| Submission: |
|
|
| Consensus Review Received: |
|
|
| Consensus Review Response: |
|
|
| Approval on hold (if applicable): |
|
|
| Final Approval: |
|
|
|
CIRB
(if needed) |
| Submission: |
|
|
| CIRB Review Received: |
|
|
| CIRB Response Submitted: |
|
|
| Approval: |
|
|
|
| Final Ops Consistency Check |
|
| Final PRC Review (if needed) |
|
| Activation Amend (CTEP) |
|
| Final Forms Inserted |
|
| FFS Inserted |
|
| Activation Memo/HIPAA |
|
| Web Documents Prepared |
|
| Database Flags Set |
|
| Comments |
|
III. ADMINISTRATIVE:
(if needed) Contract and IND will be completed by Dir. of Ops and Pharm. Liaison.
|
| Budget for Drug Distribution |
| Applicable? |
|
Date finalized |
| Yes |
|
|
|
| Budget for Additional Support |
| Applicable? |
|
Date finalized |
| Yes |
|
|
|
| Budget for Correlative Studies |
| Applicable? |
|
Date finalized |
| Yes |
|
|
|
| Contract Signed |
| Applicable? |
|
Date finalized |
| Yes |
|
|
|
| IND Assigned |
| Applicable? |
|
Date finalized |
| Yes |
|
|
|
| Other Last Minute Issues? |
Membership:
Intergroup:
Financial:
Correlates:
Drug Issues:
Other:
|
| Comments |
|
IV. ACTIVATION:
|
|
