RECRUITING

Venetoclax and Lintuzumab-Ac225 in AML Patients

Conditions

Acute Myeloid Leukemia Relapsed Adult AML Lintuzumab-Ac225 Venetoclax Lintuzumab Refractory AML

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is a multicenter, open label Phase I/II trial. 1. To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapsed/refractory AML. (Phase 1 portion) 2. To assess the percentage of patients with CR, CRh, or Overall Response (CR + CRh), up to 6 months after the start of treatment without receiving other AML therapies. (Phase 2 portion)

Official Title

A Phase I/II Study of Venetoclax and Lintuzumab-Ac225 in Patients With Refractory or Relapsed AML

Quick Facts

Study Start:2020-01-15

Study Completion:2024-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03867682

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Refractory or relapsed AML which will include: 1. Refractory disease will be defined as at least 1 prior treatment with no remission. 2. Relapsed disease will be defined as 5% or more blasts in bone marrow seen after remission. 3. Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, ts-AML) are also eligible. 2. Circulating blast count ≤ 200/μL within 10 days prior to first cycle of treatment. Hydroxyurea should be used to keep the peripheral blast count ≤ 200/μL until the first day of protocol treatment, to the extent that this is possible 3. ECOG ≤ 2 4. Estimated creatinine clearance ≥ 50 mL/min 5. AST and ALT ≤ 3.0 x ULN 6. Bilirubin ≤ 3.0 x ULN	1. Active CNS Leukemia. 2. Known HIV infection or known hepatitis B or hepatitis C infection (with a detectable viral load). 3. Participant has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment. 4. Secondary refractory AML (e.g., treated for current relapse without achieving remission); 5. Have received prior radiation to maximally tolerated levels to any critical normal organ. 6. Clinically significant cardiac disease. 7. Active, uncontrolled serious infection. 8. Have other non-myeloid malignancy within 2 years of entry (with exceptions). 9. Psychiatric disorder that would preclude study participation 10. Previous solid organ transplant (prior treatment with SCT is allowed but not if patient has GVHD or is still receiving immunosuppression/GVHD therapy).

Inclusion Criteria

Exclusion Criteria

1. Refractory or relapsed AML which will include:
1. Refractory disease will be defined as at least 1 prior treatment with no remission.
2. Relapsed disease will be defined as 5% or more blasts in bone marrow seen after remission.
3. Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, ts-AML) are also eligible.
2. Circulating blast count ≤ 200/μL within 10 days prior to first cycle of treatment. Hydroxyurea should be used to keep the peripheral blast count ≤ 200/μL until the first day of protocol treatment, to the extent that this is possible
3. ECOG ≤ 2
4. Estimated creatinine clearance ≥ 50 mL/min
5. AST and ALT ≤ 3.0 x ULN
6. Bilirubin ≤ 3.0 x ULN

1. Active CNS Leukemia.
2. Known HIV infection or known hepatitis B or hepatitis C infection (with a detectable viral load).
3. Participant has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment.
4. Secondary refractory AML (e.g., treated for current relapse without achieving remission);
5. Have received prior radiation to maximally tolerated levels to any critical normal organ.
6. Clinically significant cardiac disease.
7. Active, uncontrolled serious infection.
8. Have other non-myeloid malignancy within 2 years of entry (with exceptions).
9. Psychiatric disorder that would preclude study participation
10. Previous solid organ transplant (prior treatment with SCT is allowed but not if patient has GVHD or is still receiving immunosuppression/GVHD therapy).

Contacts and Locations

Study Contact

Actinium Pharmaceuticals, Inc.

CONTACT

+1-646-677-3878

actimab@actiniumpharma.com

Principal Investigator

Avinash Desai, MD

STUDY_CHAIR

Actinium Pharmaceuticals, Inc.

Study Locations (Sites)

University of California

Los Angeles, California, 90095

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121

United States

Weill Cornell Medicine

New York, New York, 10021

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Actinium Pharmaceuticals

Avinash Desai, MD, STUDY_CHAIR, Actinium Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-15

Study Completion Date2024-06

Study Record Updates

Study Start Date2020-01-15

Study Completion Date2024-06

Terms related to this study

Keywords Provided by Researchers

Lintuzumab-Ac225
Venetoclax
Lintuzumab
Refractory AML

Additional Relevant MeSH Terms

Acute Myeloid Leukemia
Relapsed Adult AML