Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04070768
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2019-08-26
Brief Title:
Study of the Safety and Efficacy of Gemtuzumab Ozogamicin GO and Venetoclax in Patients With Relapsed or Refractory CD33 Acute Myeloid LeukemiaBig Ten Cancer Research Consortium BTCRC-AML17-113
Sponsor:
John Quigley
Organization:
Big Ten Cancer Research Consortium
Study Overview
Official Title:
Phase Ib Study of the Safety and Efficacy of Gemtuzumab Ozogamicin GO and Venetoclax in Patients With Relapsed or Refractory CD33 Acute Myeloid LeukemiaBig Ten Cancer Research Consortium BTCRC-AML17-113
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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 Phase Ib Study to determine the Maximum Tolerated Dose MTD of Venetoclax in combination with Gemtuzumab OzogamicinGO in subjects with relapsedrefractory acute myeloid leukemia Using a standard 33 design subjects will receive once cycle of combination therapy After one cycle of combination therapy subjects showing response will continue on to one cycle of consolidation therapy with GOVeneoclax Subjects who respond to combination therapy will continue on maintenance Venetoclax until progression or unacceptable toxicity
Dose-limiting toxicity defined as an adverse event related possible probably or definite to Venetoclax andor Gemtuzumab fulfilling one of the following criteria
criteria
Hematologic toxicity treatment-related grade 3 or worse neutropenia andor thrombocytopenia due to bone marrow hypocellularity present at the end of cycle one day 28 with an additional 28 days allowed for count recovery ie present at day 56 specifically grade 3 or worse neutropenia or thrombocytopenia with the bone marrow documented to be free of leukemic infiltration Note patients who enter the study with grade 3 or worse cytopenias will not be evaluable for hematologic dose-limiting toxicities
Non-hematologic toxicity any grade 3 or worse treatment-related toxicity occurring within the first cycle excluding grade 3-4 infections during cycle one
The study will also evaluate the Overall Response Rate Anti-leukemic activity Relapse-free Survival RFS event-free survival EFS and overall survival OS The study will evaluate quality of life using the European Organization for the Research and Treatment of Cancer 30 item questionnaire EORTC QLQ-C30
Dose-limiting toxicity defined as an adverse event related possible probably or definite to Venetoclax andor Gemtuzumab fulfilling one of the following criteria
criteria
Hematologic toxicity treatment-related grade 3 or worse neutropenia andor thrombocytopenia due to bone marrow hypocellularity present at the end of cycle one day 28 with an additional 28 days allowed for count recovery ie present at day 56 specifically grade 3 or worse neutropenia or thrombocytopenia with the bone marrow documented to be free of leukemic infiltration Note patients who enter the study with grade 3 or worse cytopenias will not be evaluable for hematologic dose-limiting toxicities
Non-hematologic toxicity any grade 3 or worse treatment-related toxicity occurring within the first cycle excluding grade 3-4 infections during cycle one
The study will also evaluate the Overall Response Rate Anti-leukemic activity Relapse-free Survival RFS event-free survival EFS and overall survival OS The study will evaluate quality of life using the European Organization for the Research and Treatment of Cancer 30 item questionnaire EORTC QLQ-C30
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?:
None
Is an FDA AA801 Violation?:
None