Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428019
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-20
Brief Title:
A Study to Evaluate the Risk of Tumor Lysis Syndrome TLS in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia CLL
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Prospective Open-Label Phase IIbIII Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Chronic lymphocytic leukemia CLL is the most common leukemia cancer of blood cells The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL Adverse events and change in disease activity will be assessed
Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL Study doctors put the participants in 1 of 4 groups called treatment arms Participants will receive oral venetoclax in combination with intravenously IV infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide
Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab with a 5 week venetoclax ramp up Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib with a 5 week venetoclax ramp up Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib with differing venetoclax ramp up periods The total study duration is approximately 28 months
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL Study doctors put the participants in 1 of 4 groups called treatment arms Participants will receive oral venetoclax in combination with intravenously IV infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide
Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab with a 5 week venetoclax ramp up Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib with a 5 week venetoclax ramp up Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib with differing venetoclax ramp up periods The total study duration is approximately 28 months
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-512147-23-00 | OTHER | EU CT | None |