Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113

Part of paid clinical trials in Chicago, Illinois.

Sponsor
John Quigley
Study ID
NCT04070768
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemtuzumab Ozogamicin — DRUG
    Gemtuzumab Ozogamicin 3mg/m\^2, Days 1,4,7
  • Venetoclax — DRUG
    Venetoclax, 100,200,400, or 600mg Daily Dose

Study Details

This is a Phase Ib Study to determine the Maximum Tolerated Dose (MTD) of Venetoclax in combination with Gemtuzumab Ozogamicin(GO) in subjects with relapsed/refractory acute myeloid leukemia. Using a standard 3+3 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 GO\\Veneoclax. 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 and/or Gemtuzumab fulfilling one of the following criteria: criteria: * Hematologic toxicity: treatment-related grade 3 or worse neutropenia and/or thrombocytopenia due to bone marrow hypocellularity present at the end of cycle one (day 28) with an additional 28 days allowed for count recovery (i.e. 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).

Key Dates

Start date
Sep 6, 2019
Status verified
Apr 2025
Primary completion
Oct 12, 2023
Completion
Feb 20, 2024

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemtuzumab Ozogamicin(GO) + Venetoclax
    Gemtuzumab Ozogamicin(GO) + Venetoclax

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Venetoclax When Administered With Gemtuzumab Ozogamicin (GO) [ Time Frame: 42 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Univeristy of IllinoisChicagoIllinois60612-
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
University of Michigan Health SystemAnn ArborMichigan48109-
University of Nebraska Medical CenterOmahaNebraska68198-

Find similar trials in Chicago, IL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Univeristy of Illinois· Chicago, ILIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INUniversity of Michigan Health System· Ann Arbor, MIUniversity of Nebraska Medical Center· Omaha, NE

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