Is NCT06440135 recruiting in Boston, MA?

Yes, NCT06440135 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

The purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT. The name of the study drug involved in this study is: • Ziftomenib

Sponsor: Massachusetts General Hospital

Who Can Participate

Inclusion Criteria

18 years or older.

Pathologically confirmed diagnosis of acute myeloid leukemia (AML).

Complete remission (CR) or complete remission with incomplete count recovery (CRi) at screening.

Complete remission (CR):

no circulating blasts in peripheral blood and \<5% blasts in bone marrow

no extramedullary disease

platelet count ≥100 x 10(9)/L and/or absolute neutrophil count ≥1000/µL

Complete remission with incomplete count recovery (CRi):

no circulating blasts in peripheral blood and \<5% blasts in bone marrow

no extramedullary disease

platelet count \<100 x 10(9)/L and/or absolute neutrophil count \<1000/µL

Presence of at least one of the following molecular mutations:

KMT2A rearrangement

Eligibility and enrollment will be based on local mutational testing.

The presence of a KMT2A rearrangement (excluding partial tandem duplication \[PTD\]) at the time of initial diagnosis or any other time thereafter is sufficient.

Participants may receive additional treatment for AML between consent and transplant.

NPM1 mutation

Eligibility and enrollment will be based on local mutational testing.

For participants being transplanted in CR1, the presence of a NPM1 mutation at screening is necessary for the purposes of eligibility.

For participants being transplanted in greater than or equal to CR2, the presence of a NPM1 mutation at the time of consent is not necessary for eligibility and its presence at the time of initial diagnosis or any other time thereafter is sufficient.

Participants may receive additional treatment for AML between consent and transplant.

Treatment with a menin inhibitor prior to transplant is permitted. However, patients who experienced AML relapse or progression while being treated with a menin inhibitor prior to transplant are ineligible.

Will undergo first allogeneic HCT for their malignancy.

Transplantation will be performed with the use of conventional myeloablative (MAC) or reduced intensity conditioning (RIC).

HCT Donor will be one of the following:

5/6 or 6/6 (HLA-A, B, DR) matched related donor

7/8 or 8/8 (HLA-A, B, DR, C) matched unrelated donor. Matching in the unrelated setting must be at the allele level.

Haploidentical related donor, defined as ≥ 3/6 (HLA-A, B, DR) matched

≥ 4/6 (HLA-A, B, DR) umbilical cord blood (UCB). Matching in the UCB setting is at the antigen level. Recipients may receive either one or two UCB units. In the case of 2 UCB units, both units must have been at least 4/6 matched with the recipient.

Any non-investigational GVHD prophylaxis regimen is allowed.

Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Participants must have normal organ and function as defined below:

AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 3x institutional upper limit of normal (ULN)

Total bilirubin \< 1.5 x institutional ULN (with the exception of subjects with a history of Gilbert's syndrome, for which the total bilirubin must be \< 5 x ULN)

Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)

LVEF must be ≥50%, as measured by MUGA scan or echocardiogram.

Female patients of childbearing potential must have a negative pregnancy test, as measured by serum or urine testing.

The effects of ziftomenib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 6 months after the last dose of treatment.

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

Exclusion Criteria

History of other malignancy(ies) unless

the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or

the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up

the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin

Known diagnosis of active hepatitis B or hepatitis C

Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \< 50%, as measured by multigated acquisition (MUGA) scan or echocardiogram)

Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome

Systemic uncontrolled infection

Known dysphagia, short-gut syndrome, gastroparesis, or other condition(s) that limits the ingestion or gastrointestinal absorption of drugs administered orally

Uncontrolled hypertension (systolic blood pressure \[BP\] \> 180 mmHg or diastolic BP \> 100 mmHg)

QTc interval (i.e., Friderica's correction \[QTcF\]) ≥ 480 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening

Uncontrolled intercurrent illness that would limit compliance with study requirements.

Persons who are pregnant or lactating.

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 (NCT06440135) 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 (NCT06440135) 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 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

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