TERMINATED

Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage

Conditions

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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

Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed/refractory after 2, 3, or 4 prior induction regimens: Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6 mg/m²/day followed by a 14-day resting period per 28-day cycles. Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment.

Official Title

Phase 3 Randomized Trial of DFP-10917 vs Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High & Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second, Third, or Fourth Salvage

Quick Facts

Study Start:2019-11-22

Study Completion:2026-01-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT03926624

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. Histologically or pathologically confirmed diagnosis of AML based on WHO classification that has relapsed after, or is refractory to, two, three, or four prior induction regimens that may have included intensive chemotherapy (e.g., "7+3" cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine), or targeted therapy (e.g., FLT-3, IDH-1/2, BCL-2, monoclonal antibody). 2. Aged ≥ 18 years. 3. ECOG Performance Status of 0, 1 or 2. 4. Adequate clinical laboratory values (i.e., plasma creatinine \<2.5 x upper limit of normal (ULN) for the institution, bilirubin \<2.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 x ULN). 5. Absence of active central nervous system (CNS) involvement by leukemia. Patients with previously diagnosed CNS leukemia are eligible if the CNS leukemia is under control and intrathecal treatment may continue throughout the study. 6. Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions. 7. Signed informed consent prior to the start of any study specific procedures. 8. Women of child-bearing potential must have a negative serum or urine pregnancy test. 9. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.	1. The interval from prior treatment to time of study drug administration is \< 2 weeks for cytotoxic agents or \< 5 half-lives for noncytotoxic agents. Exceptions: Use of hydroxyurea is allowed before the start of study and is to be discontinued prior to the initiation of study treatment. At the investigator's discretion, for patients with significant leukocytosis that develops during the early treatment cycles, hydroxyurea may be administered. The hydroxyurea should be discontinued as soon as clinically appropriate. 2. Any \>grade 1 persistent clinically significant toxicities from prior chemotherapy. 3. Inadequate Cardiac (left ventricular ejection fraction ≤40%) function. 4. White blood cell (WBC) count \>15,000/μL (Note: Patients considered for possible venetoclax-containing regimen must have WBC ≤10k/μL prior to initiating venetoclax treatment). 5. For patients with prior hematopoietic stem cell transplant (HSCT): 1. Less than 3 months since HSCT 2. Acute Graft versus Host Disease (GvHD) \>Grade 1 3. Chronic GvHD \>Grade 1 6. Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance. 7. A pregnant or lactating woman. 8. Current malignancies of another type. Exceptions: Patients may participate if they have previously treated and currently controlled prostate cancer, or adequately treated in situ cervical cancer or basal cell skin cancer, or other malignancies with no evidence of disease for 2 years or more. 9. Patient has acute promyelocytic leukemia (APL). 10. Patients with known HIV, active HBV or active HCV infection (note: testing for these infections is not required). For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 11. Documented or known clinically significant bleeding disorder.

Inclusion Criteria

Exclusion Criteria

1. Histologically or pathologically confirmed diagnosis of AML based on WHO classification that has relapsed after, or is refractory to, two, three, or four prior induction regimens that may have included intensive chemotherapy (e.g., "7+3" cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine), or targeted therapy (e.g., FLT-3, IDH-1/2, BCL-2, monoclonal antibody).
2. Aged ≥ 18 years.
3. ECOG Performance Status of 0, 1 or 2.
4. Adequate clinical laboratory values (i.e., plasma creatinine \<2.5 x upper limit of normal (ULN) for the institution, bilirubin \<2.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 x ULN).
5. Absence of active central nervous system (CNS) involvement by leukemia. Patients with previously diagnosed CNS leukemia are eligible if the CNS leukemia is under control and intrathecal treatment may continue throughout the study.
6. Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
7. Signed informed consent prior to the start of any study specific procedures.
8. Women of child-bearing potential must have a negative serum or urine pregnancy test.
9. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.

1. The interval from prior treatment to time of study drug administration is \< 2 weeks for cytotoxic agents or \< 5 half-lives for noncytotoxic agents. Exceptions: Use of hydroxyurea is allowed before the start of study and is to be discontinued prior to the initiation of study treatment. At the investigator's discretion, for patients with significant leukocytosis that develops during the early treatment cycles, hydroxyurea may be administered. The hydroxyurea should be discontinued as soon as clinically appropriate.
2. Any \>grade 1 persistent clinically significant toxicities from prior chemotherapy.
3. Inadequate Cardiac (left ventricular ejection fraction ≤40%) function.
4. White blood cell (WBC) count \>15,000/μL (Note: Patients considered for possible venetoclax-containing regimen must have WBC ≤10k/μL prior to initiating venetoclax treatment).
5. For patients with prior hematopoietic stem cell transplant (HSCT):
1. Less than 3 months since HSCT
2. Acute Graft versus Host Disease (GvHD) \>Grade 1
3. Chronic GvHD \>Grade 1
6. Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
7. A pregnant or lactating woman.
8. Current malignancies of another type. Exceptions: Patients may participate if they have previously treated and currently controlled prostate cancer, or adequately treated in situ cervical cancer or basal cell skin cancer, or other malignancies with no evidence of disease for 2 years or more.
9. Patient has acute promyelocytic leukemia (APL).
10. Patients with known HIV, active HBV or active HCV infection (note: testing for these infections is not required). For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
11. Documented or known clinically significant bleeding disorder.

Contacts and Locations

Principal Investigator

Tapan Kadia, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

O'Neal Comprehensive Cancer Center

Birmingham, Alabama, 35294

United States

Banner MD Anderson

Gilbert, Arizona, 85234

United States

HonorHealth (VGPCC Cancer Transplant Institute)

Scottsdale, Arizona, 85258

United States

The University of Arizona Cancer Center

Tucson, Arizona, 85724-5024

United States

University of California

Irvine, California, 92697

United States

UCLA

Los Angeles, California, 90095

United States

UF-Health Cancer Center Gainesville

Gainesville, Florida, 32608

United States

Baptist MD Anderson

Jacksonville, Florida, 32207

United States

UF-Health Jacksonville

Jacksonville, Florida, 32209

United States

AdventHealth Medical Group Blood and Marrow Transplant at Orlando

Orlando, Florida, 32804

United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912

United States

Rush University

Chicago, Illinois, 60612

United States

Decatur Memorial Hospital-Cancer Care Specialists of Central IL

Decatur, Illinois, 62526

United States

Loyola University Medical Center

Hines, Illinois, 60153

United States

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237

United States

The University of Kansas Cancer Center

Westwood, Kansas, 66205

United States

University of KY- Markey Cancer Center

Lexington, Kentucky, 40536

United States

Norton Cancer Institute

Louisville, Kentucky, 40241

United States

Ochsner Benson Cancer Center

Jefferson, Louisiana, 70121

United States

Tulane University

New Orleans, Louisiana, 70118

United States

Henry Ford Cancer Institute

Detroit, Michigan, 48202

United States

The University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

New York Medical College

Valhalla, New York, 10595

United States

Novant Health Cancer Institute - Elizabeth (Hematology)

Charlotte, North Carolina, 28204

United States

East Carolina University

Greenville, North Carolina, 27834

United States

Vidant Oncology

Kinston, North Carolina, 28501

United States

Novant Health Cancer Institute - Forsyth (Hematology)

Winston-Salem, North Carolina, 27103

United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Gabrail Cancer Center

Canton, Ohio, 44718

United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, 45267

United States

Seidman Cancer Center, University Hospitals, Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Prisma Health Cancer Institute

Greenville, South Carolina, 29605

United States

Avera Medical Group

Sioux Falls, South Dakota, 57105

United States

UT Southwestern

Dallas, Texas, 75390

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

University of Vermont Medical Center

Burlington, Vermont, 05401

United States

University of Virginia Health System

Charlottesville, Virginia, 22903

United States

Multicare Institute for Research and Innovation

Spokane, Washington, 99218

United States

Collaborators and Investigators

Sponsor: Delta-Fly Pharma, Inc.

Tapan Kadia, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Date2019-11-22

Study Completion Date2026-01-07

Study Record Updates

Study Start Date2019-11-22

Study Completion Date2026-01-07

Terms related to this study

Additional Relevant MeSH Terms

Leukemia, Myeloid, Acute