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SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission

A Phase 1/2 Study of SL-401 as Consolidation Therapy for Adult Patients With Adverse Risk Acute Myeloid Leukemia in First CR, and/or Evidence of Minimal Residual Disease (MRD) in First CR

NCT02270463•Stemline Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a non-randomized, open-label, multicenter, dose escalation study designed to determine the maximum tolerated dose (MTD) of SL-401 in adult patients with acute myeloid leukemia, and to evaluate the safety profile of SL-401 at the MTD.

Detailed Description

Patients who were in their first or second complete remission (CR) or complete remission with incomplete bone marrow recovery (CRi) after induction therapy were treated with SL-401, which was administered as a brief intravenous infusion for 5 consecutive days every 28 days for 6 or more cycles. Stage 1 consisted of a period in which patients were treated with SL-401 at 3 dose levels. During Stage 2, patients with minimal residual disease (MRD) in their bone marrow were treated at a MTD or maximum tested dose in which multiple dose-limiting toxicities were not observed (identified in Stage 1).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient has a diagnosis of AML according to World Health Organization (WHO) criteria.
•2. The patient received any induction chemotherapy regimen and may have received post-remission consolidation therapy prior to screening.
•3. The patient has achieved a first or second CR or CRi. For patients without evidence of MRD in CR/CRi, CR (or CRi) must have been initially identified within 12 months prior to screening.
•OR The patient has achieved first or second CR or CRi with evidence of MRD as determined locally at least 6 months post stem cell transplant without evidence of acute or chronic graft-versus-host disease post-transplant and has not received immunosuppressant therapy for at least 14 days prior to SL-401 therapy.
•4. The patient has adverse risk disease or AML for which there is otherwise a substantial risk of relapse, which includes but is not limited to: adverse karyotype, FLT3 internal tandem duplication (ITD) mutation, history of antecedent hematologic disorder (AHD), therapy-related AML, history of requiring more than 1 cycle of intensive induction chemotherapy to achieve first remission, and/or presence of persistent MRD (detected by cytogenetics, molecular markers, or flow cytometry) at any point after the initial induction cycle.
•5. For patients enrolling in Stage 2, the bone marrow evaluation determined locally within the previous 6 months indicates the presence of MRD.
•6. The patient is not considered to be an immediate candidate for allogeneic stem cell transplant as determined by the investigator.
•7. The patient is ≥18 years old.
•8. The patient has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0-2.
•9. The patient has adequate organ function, including cardiac, renal, and hepatic function:
+23 more criteria

Exclusion Criteria

•1. The patient has a diagnosis of AML associated with karyotype t(15;17).

Locations (7)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

Tennessee Oncology

Nashville, Tennessee, United States

M.D. Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Institute

Seattle, Washington, United States

Key Dates

Start Date

February 1, 2015

Primary Completion Date

December 1, 2019

Completion Date

December 1, 2019

Last Updated

October 17, 2024

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

Tagraxofusp-erzs

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

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