Study of Alvocidib in Patients With Relapsed/Refractory AML Following Treatment With Venetoclax Combination Therapy
NCT ID: NCT03969420
Last Updated: 2023-11-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
11 participants
INTERVENTIONAL
2020-01-15
2021-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lead-In Cohort: Arm 1
Refractory (i.e., failed to achieve a CR/CRi or achieved a CR/CRi with duration \<90 days)
Alvocidib (flavopiridol) and cytarabine (Ara-C)
Alvocidib (flavopiridol), administered intravenously, + cytarabine (Ara-C), administered by subcutaneous injection
Lead-In Cohort: Arm 2
Relapsed (i.e., reoccurrence of disease following a CR/CRi with duration ≥90 days).
Alvocidib (flavopiridol)
Administered intravenously
Stage 1: Arm 1
Refractory (i.e., failed to achieve a CR/CRi or achieved a CR/CRi with duration \<90 days)
Alvocidib (flavopiridol) and cytarabine (Ara-C)
Alvocidib (flavopiridol), administered intravenously, + cytarabine (Ara-C), administered by subcutaneous injection
Stage 1: Arm 2
Relapsed (i.e., reoccurrence of disease following a CR/CRi with duration ≥90 days).
Alvocidib (flavopiridol)
Administered intravenously
Interventions
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Alvocidib (flavopiridol) and cytarabine (Ara-C)
Alvocidib (flavopiridol), administered intravenously, + cytarabine (Ara-C), administered by subcutaneous injection
Alvocidib (flavopiridol)
Administered intravenously
Eligibility Criteria
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Inclusion Criteria
2. Have an established, pathologically confirmed diagnosis of AML by World Health Organization (WHO) criteria, excluding acute promyelocytic leukemia (APL-M3) with a bone marrow of \>5% blasts based on histology or flow cytometry.
3. Have received initial induction therapy with venetoclax in combination with azacytidine or decitabine (with or without other investigational agents as part of a clinical trial; requires Medical Monitor review) and were either refractory (failed to achieve a CR/CRi or achieved a CR/CRi with duration \<90 days) or have relapsed (reoccurrence of disease following a CR/CRi with duration ≥90 days).
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
5. Have a glomerular filtration rate (GFR) ≥30 mL/min using the Cockcroft-Gault equation.
6. Have an alanine aminotransferase (ALT)/aspartate aminotransferase (AST) level ≤5 times upper limit of normal (ULN).
7. Have a total bilirubin level ≤2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia).
8. Be infertile or agree to use an adequate method of contraception:sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry, for the duration of study participation, and for at least 3 months (males) and 6 months (females) after the last dose of study drug.
9. Be able to comply with the requirements of the entire study.
10. Provide written informed consent prior to any study related procedure: in the event that the patient is re-screened for study participation or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.
Exclusion Criteria
2. Require concomitant chemotherapy, radiation therapy, or immunotherapy. Hydroxyurea is allowed up to the evening before starting (but not within 12 hours) of starting treatment on either arm.
3. Received an allogeneic stem cell transplant within 60 days of the start of study treatment. Patients who received an allogeneic stem cell transplant must be off all immunosuppressants at the time of study treatment
4. Are receiving or have received systemic therapy for graft-versus-host disease.
5. Have a peripheral blast count of \>30,000/mm3 (may use hydroxyurea as in #2 above).
6. Received antileukemic therapy within the last 2 weeks or 3-5 half lives of the prior therapy (with the exception of hydroxyurea or if the patient has definite refractory disease), whichever is less. Refractory patients who received therapy within the last 2 weeks may be eligible with prior approval of the Medical Monitor.
7. Diagnosed with acute promyelocytic leukemia (APL-M3).
8. Have active central nervous system (CNS) leukemia.
9. Have evidence of uncontrolled disseminated intravascular coagulation.
10. Have an active, uncontrolled infection.
11. Have other life-threatening illness.
12. Have other active malignancies requiring treatment or diagnosed with other malignancies within the last 6 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia.
13. Have mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.
14. Are pregnant and/or nursing.
15. Have received any live vaccine within 14 days prior to first study drug administration.
18 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Anthony, DO
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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Community Medical Providers
Clovis, California, United States
City of Hope National Medical Center, City of Hope Medical Center
Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
Advent Health Medical Group Blood & Marrow Transplant at Orlando
Orlando, Florida, United States
Orlando Health, Inc, Univ of Florida Health Cancer Center
Orlando, Florida, United States
Indiana Blood and Marrow Translplantation - Clinic
Indianapolis, Indiana, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
University of New Mexico
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina (UNC)
Chapel Hill, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health & Sciences University - Knight Cancer Institute - Center for Hematologic Malignancies
Portland, Oregon, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Baylor University Center
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TPI-ALV-202
Identifier Type: -
Identifier Source: org_study_id
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