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TERMINATEDPHASE1

Avelumab With Decitabine as First Line for AML Treatment of Patients With AML, Who Are Unfit for Intensive Chemotherapy

A Phase I Study of Avelumab in Combination With Decitabine as First Line Treatment of Patients With AML, Who Are Unfit for Intensive Chemotherapy

NCT03395873•Milton S. Hershey Medical Center

View on ClinicalTrials.gov

Summary

The goal of this study is to test the safety of combination treatment with Avelumab and Decitabine in newly diagnosed AML patients who are unfit for intensive induction chemotherapy.

Detailed Description

This is a single arm, open label phase I study with expansion to evaluate safety and tolerability of Avelumab in combination with Decitabine in patients with untreated AML, who are unfit for intensive chemotherapy. Decitabine will be given 20mg/m2 IV day 1-5, every 28 days. Avelumab will be given at 10mg/kg IV (initial dose) day 1, every 14 days. Using a standard 3x3 statistical design, protocol defined Dose Limiting Toxicities (DLT) will be assessed. In expansion stage, we will perform an expansion cohort of 9 additional patients using the Maximum Tolerated Dose (MTD) established in the Phase I portion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) according to WHO classification.
•2. Previously untreated AML except for hydroxyurea.
•3. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of avelumab in combination with decitabine in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric trials.
•4. Performance status (ECOG) of 0-2 (see Appendix A).
•5. Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER:
•* 75 years of age OR \<75 years of age with at least 1 of the following: Poor performance status (ECOG) score of 2.
•Clinically significant heart or lung comorbidities, as reflected by at least 1 of:
•Left ventricular ejection fraction (LVEF) ≤50%. Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected. Forced expiratory volume in 1 second (FEV1) ≤65% of expected. Chronic stable angina or congestive heart failure controlled with medication. Liver transaminases \>3 × upper limit of normal (ULN). Other contraindication(s) to anthracycline therapy. Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy. The enrollee declines intensive remission induction chemotherapy.
•6. Creatinine clearance as estimated by the Cockcroft-Gault (C-G) or other medically acceptable formulas ≥30 mL/min.vii. Cytogenetic features justify hypo-methylating agents as induction treatment.
•7. Life expectancy \> 12 weeks (3months).
+5 more criteria

Exclusion Criteria

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•1. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
•2. Patients who are receiving any other investigational agents.
•3. Patients should be excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
•4. Patients with known CNS involvement will be excluded because of poor prognosis and concerns regarding progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•5. History of severe hypersensitivity reaction to any monoclonal antibody.
•6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•7. Pregnant women are excluded from this study because avelumab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with avelumab, breastfeeding should be discontinued if the mother is treated with avelumab.
•8. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) might be enrolled if the viral load by PCR is undetectable with/without active treatment and absolute lymphocyte count \>= 350/ul.
•Patients with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment.
+9 more criteria

Locations (1)

Penn State Cancer Institute

Hershey, Pennsylvania, United States

Key Dates

Start Date

January 29, 2018

Primary Completion Date

May 15, 2019

Completion Date

May 15, 2019

Last Updated

August 21, 2019

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

Avelumab

DRUG

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NCT06285890

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RECRUITINGPHASE2

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RECRUITINGPHASE1/PHASE2

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

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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: August 21, 2019Data 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.

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Avelumab With Decitabine as First Line for AML Treatment of Patients With AML, Who Are Unfit for Intensive Chemotherapy

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2