Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-30 @ 1:02 PM
Study NCT ID:
NCT04855695
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2021-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avo In R/R And Previously Untreated MCL
Sponsor:
Austin I Kim
Organization:
Study Overview
Official Title:
A Phase 1/2 Study of Acalabrutinib, Venetoclax, and Obinutuzumab in Patients With Relapsed/Refractory and Previously Untreated Mantle Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-01
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 research study is evaluating the combination of three drugs - acalabrutinib, venetoclax, and obinutuzumab - as a possible treatment for relapsed or refractory and untreated mantle cell lymphoma (MCL).
The names of the study drugs involved in this study are:
* Acalabrutinib
* Venetoclax
* Obinutuzumab
The names of the study drugs involved in this study are:
* Acalabrutinib
* Venetoclax
* Obinutuzumab
Detailed Description:
This is an open-label, investigator-initiated, single-arm, multi-cohort phase 1/2 study to assess the safety and efficacy of the combination of acalabrutinib, venetoclax, and obinutuzumab (AVO) in relapsed/refractory (R/R) and untreated mantle cell lymphoma (MCL).
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
The names of the study drugs involved in this study are:
* Acalabrutinib
* Venetoclax
* Obinutuzumab
Participants will receive study treatment for as long as there are no serious side effects and the disease does not get worse. Participants will be followed for 5 years.
It is expected that 53 people will take part in this research study.
This is a Phase I/II clinical trial. Phase I clinical trials test the safety of investigational drugs and also tries to define the appropriate dose of investigational drugs to use for further studies. "Investigational" means that the drugs are being studied.
* The U.S. Food and Drug Administration (FDA) has not approved venetoclax and obinutuzumab for this specific disease but it has been approved for other uses.
* The U.S. Food and Drug Administration (FDA) has approved acalabrutinib as a treatment option for this disease.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
The names of the study drugs involved in this study are:
* Acalabrutinib
* Venetoclax
* Obinutuzumab
Participants will receive study treatment for as long as there are no serious side effects and the disease does not get worse. Participants will be followed for 5 years.
It is expected that 53 people will take part in this research study.
This is a Phase I/II clinical trial. Phase I clinical trials test the safety of investigational drugs and also tries to define the appropriate dose of investigational drugs to use for further studies. "Investigational" means that the drugs are being studied.
* The U.S. Food and Drug Administration (FDA) has not approved venetoclax and obinutuzumab for this specific disease but it has been approved for other uses.
* The U.S. Food and Drug Administration (FDA) has approved acalabrutinib as a treatment option for this disease.
Study Oversight
Has Oversight DMC:
True
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?: