Is NCT06660368 recruiting in Boston, MA?

Yes, NCT06660368 is currently recruiting participants at its Boston, MA location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Boston, 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 Boston 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 Boston, MA

About This Acute Myeloid Leukemia Study in Boston

This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Who Can Participate

Inclusion Criteria

Provision of signed and dated informed consent form.

Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.

Adults aged ≥18 years - 80 years.

Patients with documented refractory or relapsed AML: Refractory disease is defined as failure to achieve CR (i.e., \<5% blasts in BM or blood) with or without normal restoration of hematopoiesis (Cri) after at least 1 cycle of intensive induction therapy (or 2 cycles of non-intensive induction). Relapse: Recurrence of disease after achieving remission, meeting one or more of the following criteria: ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease.

Secondary AML arising out of MDS previously treated with HMA, HMA + venetoclax (if \> 3 months from venetoclax exposure), and/or 1 cycle of induction chemotherapy.

Extramedullary AML with marrow involvement is allowed as long as concurrent medullary AML is present.

ECOG performance status ≤ 2.

Participants must have adequate organ function as defined within the protocol.

Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not mandatory.

For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

Participants with a history of hepatitis C virus (HCV) infection must have been treated and have an undetectable HCV viral load. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Testing is not mandatory.

Women of child-bearing potential and men 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 4 months after completion of study drug administration.

Exclusion Criteria

Venetoclax-refractory disease or recent venetoclax exposure \< 3 months prior to first dose of study therapy.

Prior treatment with a high-dose cytarabine-containing regimen (e.g., no prior CLAG/FLAG/MEC/CLIA/HAM, etc.).

Allogeneic stem cell transplant in the past 3 months.

Less than 14 days from last AML-directed therapy or five half-lives, whichever is shorter, not including hydroxyurea.

Known history of prior TP53 mutation (results from any myeloid mutation panel are not required for screening eligibility).

Active CNS involvement by AML.

WBC count ≥25k at the time study treatment begins.

Uncontrolled intercurrent systemic illness that would limit compliance.

Concurrent malignancy in addition to AML that requires active treatment with some exceptions.

Immunosuppressive therapy in the past 14 days except for prednisone at ≤ 10 mg/day or equivalent AND no active or uncontrolled graft-versus-host disease (GvHD).

Participants who have not recovered from adverse events (Aes) due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1), with the exception of alopecia.

Participants who are receiving any other investigational agents.

Participants with psychiatric illness/social situations that would limit compliance with study requirements.

Patients with active heart disease that limits the use of mitoxantrone or recent (\<6 months) history of an acute cardiovascular event (STEMI, NSTEMI).

Pregnant women are excluded from this study because venetoclax, cladribine, and cytarabine are agents 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 these drugs, breastfeeding should be discontinued.

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 Boston?

Yes, this clinical trial (NCT06660368) has an active research site in Boston, MA 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 Boston, MA

If you're searching for acute myeloid leukemia treatment options in Boston, MA, this clinical trial (NCT06660368) 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 Boston 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 Boston, MA

Expert Care in Boston

IRB Approved

No-Cost Care

Apply for This Boston Location

Why Participate?

Simple Process