Houston, TXNCT05986240Now EnrollingIRB Ready

AML/MDS Clinical Trial in Houston, TX

Access cutting-edge aml/mds treatment through this clinical trial at a research site in Houston. Study-provided care at no cost to qualified participants.

Sponsored by Montefiore Medical Center

Quick Self-Assessment

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Preparing your pre-screening questions…

Expert Care in Houston

Access aml/mds specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related aml/mds treatment provided free

Apply for This Houston Location

Check if you qualify for this aml/mds clinical trial in Houston, TX

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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 Houston

    Convenient for TX 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 Houston site if eligible
  4. 4Begin participation

About This AML/MDS Study in Houston

This is a Phase 1 study investigating the safety and efficacy of Danvatirsen as a monotherapy followed by combination with Venetoclax in patients with relapsed/refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). Funding Source: FDA OOPD

Sponsor: Montefiore Medical Center

Who Can Participate

Inclusion Criteria

Subjects must be at least 18 years of age at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF; and be able to meet all study requirements
Morphologically confirmed diagnosis of AML or MDS in accordance with World Health Organization (WHO) diagnostic criteria
Subjects with relapsed/refractory AML who are refractory or relapsed to all conventional therapy and do not have any FDA approved or standard therapeutic options \& subjects with intermediated/high/very high IPSS-R MDS who are refractory or relapsed to at least 2 cycles of hypomethylating agent based therapy (azacitidine / decitabine based) OR patients with rapid progression of disease regardless of number of cycles of therapy
At least 3 months from Allogenic stem cell transplantation and no clinical sign of active graft vs host disease (GVHD)
WBC must be \<25,000 cells/uL and may be reduced with hydroxyurea to reach this goal prior to study start. Hydroxyurea can be administered on trial with an increase in WBC counts at the discretion of the PI
A bone marrow biopsy must be performed within the screening window (day-28-day-1) and tissue collected for correlative analysis for entrance to this trial. Correlative sample collection is essential on this study
Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Recovery to ≤ Grade 1 or baseline for any toxicities considered to be due to prior systemic treatments, excluding alopecia
Must have adequate hepatic and renal function as follows: ALT (SGPT) and/or AST (SGOT) ≤ 3x upper limit of normal (ULN) or ≤ 5x ULN if considered to be leukemia related; Direct bilirubin ≤ 1.5 x ULN or ≤ 3x ULN (in patients with known Gilberts syndrome or if considered to be leukemia related)
Serum creatinine clearance ≥ 45 mL/min/1.73 m2 either measured or calculated using standard Cockroft-Gault formula
Subjects enrolled within childbearing ages of 18-50 years should use 2 forms of contraception while on study

Exclusion Criteria

Acute Promyelocytic Leukemia
Low or very low risk MDS by IPSS-R after failure/progression of first line therapy with hypomethylating agents
Active, uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are eligible. Use of prophylactic anti-microbials per institutional standards is allowed
Active documented central nervous system (CNS) leukemia. Patients with a known history of CNS leukemia will be eligible if they have at least two most recent consecutive LPs showing clearance of CNS disease and no active/progressive symptoms thought to be related to the CNS disease
Concurrent treatment with a non-permitted concomitant medication (as noted in protocol appendix)
Concurrent anticancer treatment, major surgery, or the use of any investigational drug within 14 days before the start of trial treatment
Other malignancy currently being treated or likely to need treatment in next 6 months with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ, surgically removed malignancies or malignancies definitively treated with chemotherapy, XRT and/or surgery with no evidence of active malignancy or not anticipated to need treatment in next 6 months or malignancies on maintenance therapy (e.g. tamoxifen for breast cancer) will be allowed after discussion and approval by both MPIs
Pregnant or breastfeeding females
Known current alcohol or drug abuse
Clinically significant cardiovascular disease within the past 6 months (e.g. percutaneous intervention, coronary artery bypass graft, documented NYHA class III/IV cardiac heart failure, unstable angina or MI, poorly controlled atrial or ventricular arrhythmia) as determined by the investigator
Any psychiatric condition that would prohibit the understanding or rendering of informed consent
Legal incapacity or limited legal capacity to sign consent and/or participate in the trial
Any condition deemed by the investigator to make the patient a poor candidate for clinical trial and/or treatment with investigational agents
Previous exposure to the investigational agent (danvatirsen)

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 Houston?

Yes, this clinical trial (NCT05986240) has an active research site in Houston, TX 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.

AML/MDS Treatment Options in Houston, TX

If you're searching for aml/mds treatment options in Houston, TX, this clinical trial (NCT05986240) 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 Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aml/mds 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 aml/mds clinical trials near you to find additional studies recruiting in your area.

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