Hackensack, NJNCT04256317Now EnrollingIRB Ready

Acute Myeloid Leukemia Clinical Trial in Hackensack, NJ

Access cutting-edge acute myeloid leukemia treatment through this phase 2/3 clinical trial at a research site in Hackensack. Study-provided care at no cost to qualified participants.

Sponsored by Taiho Oncology, Inc.

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Expert Care in Hackensack

Access acute myeloid leukemia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related acute myeloid leukemia treatment provided free

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Check if you qualify for this acute myeloid leukemia clinical trial in Hackensack, NJ

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Hackensack

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Hackensack site if eligible
  4. 4Begin participation

About This Acute Myeloid Leukemia Study in Hackensack

Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms and a Phase 1 Combination Therapy arm Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidin

Sponsor: Taiho Oncology, Inc.

Who Can Participate

Inclusion Criteria

Phase 2 Monotherapy: 1\. Has Confirmed MDS, CMML, or other MDS/MPN diagnosis who are candidates to receive and benefit from single agent azacitidine and as applicable according to local country approvals and/or local institution standard practice.
Phase 3 Monotherapy:
Has confirmed MDS or CMML and is a candidate to receive and benefit from single agent azacitidine as applicable according to local country approvals and/or local institution standard practice: a) French-American-British myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and CMML or MDS with intermediate-2 or high risk MDS according to the International Prognostic Scoring System (IPSS).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Participants with adequate organ function.
For participants with prior allogeneic stem cell transplant, no evidence of graft-versus-host disease (GVHD).
Participants with no major surgery within 3 weeks before first study treatment.
Participants with no cytotoxic chemotherapy (excluding hydroxyurea) within 4 weeks before first study treatment.
Is able to swallow the number of tablets/capsules required for the treatment assignment within a 10-minute period and tolerate 4 hours of fasting.
Participants with projected life expectancy of at least 12 weeks.
Phase 1 and Phase 2 Combination Therapy:
Has histological confirmation of newly diagnosed AML by World Health Organization (WHO) 2022 criteria (Phase 1) or 2016 criteria (Phase 2).
Participants with projected life expectancy of at least 12 weeks.
Must be considered ineligible for intensive induction chemotherapy defined by the following: a. Aged 75 years or older, or b. Aged 18 to 74 years with at least one of the following comorbidities: i. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina). ii. Severe pulmonary disorder (e.g., diffusing capacity of the lung for carbon monoxide (DLCO) ≤65% or forced expiratory volume in 1 second \[FEV1\] ≤65%). iii. Creatinine clearance ≥30 mL/min to \<45 mL/min. iv. Moderate hepatic impairment with total bilirubin \>1.5 to ≤3.0 × upper limit of normal (ULN). v. ECOG Performance Status of 2 or 3.
Has an ECOG Performance Status of 0-2 for participants ≥75 years of age or 0-3 for participants 18 to 74 years of age.

Exclusion Criteria

All Monotherapy Phases:
Has an active uncontrolled gastric or duodenal ulcer.
Has poor medical risk because of other conditions.
Has known human immunodeficiency virus (HIV) infection.
Is known to be positive for Hepatitis B or C infection.
Has a life-threatening illness.
Has a history of other malignancies prior to study entry, with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected or adequately treated and controlled with other modalities; and any early stage malignancy for which no definitive therapy is required.
Participants with MDS/MPN including CMML who have clinical extramedullary disease including clinically palpable hepatomegaly or splenomegaly.
Has previous treatment with more than 1 cycle of decitabine, azacitidine, or guadecitabine (Phases 2 and 3 only).
Has been treated with any investigational drug or therapy within 2 weeks, or 5 half-lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing clinically significant adverse events from previous treatment with investigational drug or therapy.
Has a known or suspected hypersensitivity to cedazuridine or azacitidine or any of their excipients.
Cannot discontinue treatment with any drugs that delay gastric emptying such as glucagon-like peptide-1 (GLP-1) and/or gastric inhibitory polypeptide (GIP) agonists in Cycles 1 and 2 of the study.
Has a known or suspected hypersensitivity to cedazuridine or azacitidine or any of their excipients.
Phase 1 and Phase 2 Combination Therapy:
Has a history of MPN including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation.
Has the following karyotype abnormalities: t(15;17) or other acute promyelocytic leukemia variants that remain sensitive to all-trans retinoic acid (ATRA) therapy \[t(8;21) and inv(16) are excluded in Phase 2 only\].
Has known active central nervous system involvement from AML.
Has known human immunodeficiency virus (HIV) infection.
Is known to be positive for Hepatitis B or C infection.
Has severe hepatic impairment
Has severe renal impairment
Has a malabsorption syndrome or other condition that precludes enteral route of administration.
Has a cardiovascular disability status of New York Heart Association Class \>2.
Has significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular, or pulmonary disease; or any other medical condition that in the opinion of the investigator would adversely affect his/her participation in this study.
Has clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal).
Has a history of other malignancies prior to study entry with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or adequately treated and controlled with other modalities); and any early stage malignancy for which no definitive therapy is required.
Has a WBC count \>25,000/ microliters (μL) (hydroxyurea treatment is permitted to meet this criterion).
Has received treatment with any of the following:
A hypomethylating agent (azacitidine or decitabine) or venetoclax, including prior treatment for MDS.
Chimeric Antigen Receptor (CAR)-T cell therapy.
Investigational therapies for MDS or AML.
Cannot discontinue treatment with any of the following:
Prophylactic antifungal therapy with CYP3A inhibitor activity or other concomitant medications with moderate or strong CYP3A inhibitor activity ≥7 days or 5 halflives, whichever is greater, prior to Cycle 1 Day 1 (C1D1).
Drugs that are strong CYP3A or P-gp inhibitors ≥7 days or 5 half-lives, whichever is greater, prior to C1D1.
Cannot avoid concomitant drugs known as moderate or strong CYP3A inducers.
Cannot discontinue treatment with any drugs that delay gastric emptying such as GLP-1 and/or GIP agonists in Cycles 1 and 2 of the study.
Is participating in another research study requiring interventions such as drug therapy or study procedures.
Has a known or suspected hypersensitivity to cedazuridine, azacitidine, venetoclax, or any of their excipients.
Has known significant mental illness or other conditions such as alcohol or other substance abuse or addictions
Consumes grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit ≤7 days prior to C1D1.

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 Hackensack?

Yes, this clinical trial (NCT04256317) has an active research site in Hackensack, NJ 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 Hackensack, NJ

If you're searching for acute myeloid leukemia treatment options in Hackensack, NJ, this clinical trial (NCT04256317) 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 Hackensack research site is actively enrolling participants for this phase 2/3 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.

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