Is NCT04905810 recruiting in Oklahoma City, OK?

Yes, NCT04905810 is currently recruiting participants at its Oklahoma City, OK location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia clinical trial in Oklahoma City?

To join this clinical trial in Oklahoma City, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Oklahoma City clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Myeloid Leukemia Clinical Trial in Oklahoma City, OK

About This Acute Myeloid Leukemia Study in Oklahoma City

This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Sponsor: Brian Jonas

Who Can Participate

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent

Diagnosis of AML by World Health Organization (WHO) 2016 criteria (Arber 2016)

Age \>= 18 years

Treatment naïve and eligible for venetoclax plus HMA: \

Age \>= 75 OR \

Age \>= 18-74 with at least one of the following co-morbidities: \*\

Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3 \*\

Cardiac history of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) =\< 50% or chronic unstable angina \*\

Carbon monoxide diffusing capability (DLCO) =\< 65% or forced expiratory volume in 1 second (FEV1) =\< 65% \*\

Creatinine clearance \>= 30 mL/min to =\< 45 mL/min \*\

Moderate hepatic impairment with total bilirubin \> 1.5 to =\< 3 x upper limit of normal (ULN) \*\

Any other situation that the investigator judges to be incompatible with intensive chemotherapy must be reviewed with the study chair before study enrollment

Patient experienced HMA failure for an antecedent hematologic disorder (e.g. myelodysplastic syndrome) prior to study entry (Santini 2019), defined as: \

Disease progression or stable disease as best response to \>= 4 cycles of HMA or \>= 2 cycles of HMA combination therapy (primary resistance) OR \

Relapse or progression after prior response to HMA (secondary resistance)

Prior decitabine and/or azacitidine, including oral formulations, for antecedent hematologic disorder is required. The patient should be treatment naïve for the AML diagnosis

Prior allogeneic hematopoietic transplant for antecedent hematologic disorder is allowed if done at least 3 months prior to enrollment and there is no evidence of active graft versus host disease (GVHD) or requirement for systemic immune suppression

ECOG performance status of: \

0 to 2 for subjects \>= 75 years of age OR \

0 to 3 for subjects \>= 18-74 years of age

Whole blood cell (WBC) \>= 25,000/mm\^3 at the start of study therapy (leukapheresis and hydroxyurea areallowed to meet this criteria)

Total bilirubin =, 1.5 x institution's ULN unless related to AML or Gilbert's syndrome (subjects who are \>= 18-74 may have a total bilirubin of =\< 3 x institution's ULN)

Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SPGT) =\< 3 x institutional ULN unless related to AML

Creatinine clearance \>= 30 mL/min (calculated by the Cockcroft Gault formula or measured by 24-hours urine collection)

Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. \

A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: \*\

Has not undergone a hysterectomy or bilateral oophorectomy; or \*\

Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Women of child-bearing potential has negative pregnancy test prior to initiating study drug dosing

Able to swallow and retain oral medication

Exclusion Criteria

Current or anticipated use of other investigational agents within 14 days or 5 half-lives (whichever is shorter) prior to the first dose and throughout venetoclax administration

Diagnosis of acute promyelocytic leukemia

Active central nervous system involvement by AML

Anticancer therapies, including investigational therapy, chemotherapy, targeted small molecule agents, or radiotherapy within 14 days or 5 half-lives (whichever is shorter) prior to the first dose and throughout venetoclax administration. Biologic agents (e.g. monoclonal antibodies) given for anti-neoplastic intent within 30 days prior to the first dose and throughout venetoclax administration

Prior therapy with venetoclax

Known diagnosis of human immunodeficiency virus (HIV) infection or known active hepatitis A, B or C infection with the exception of those with an undetectable viral load and CD4+ T-cell (CD4+) counts \>= 350 cells/μL within 3 months of starting study treatment. Should have no titers within 28d of day 1. Patients with hepatitis C virus (HCV) infection should have completed curative antiviral treatment

Known strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment

Subject has consumed grapefruit, grapefruit products, Seville oranges or starfruit within 3 days prior to the initiation of study treatment

Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements)

History of other malignancies, except for malignancy treated with curative intent with no known active disease present for \>= 1 year; treated non-melanoma skin cancer; and localized, cured prostate and cervical cancer

Evidence of uncontrolled active systemic infection requiring therapy (viral, bacterial, or fungal). Fever of unknown origin is not an exclusion criterion, as this may be disease related

History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study

Subject has a malabsorption syndrome of other condition that precludes enteral route of administration

Subjects with a cardiovascular disability status of New York Heart Association class greater than 2

Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Oklahoma City?

Yes, this clinical trial (NCT04905810) has an active research site in Oklahoma City, OK that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia Treatment Options in Oklahoma City, OK

If you're searching for acute myeloid leukemia treatment options in Oklahoma City, OK, this clinical trial (NCT04905810) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Oklahoma City research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced acute myeloid leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Oklahoma City, OK

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