Boston, MANCT06152809Now EnrollingIRB Ready

Acute Myeloid Leukemia Clinical Trial in Boston, MA

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

Sponsored by Dana-Farber Cancer Institute

Quick Self-Assessment

See if you qualify for this Boston location

Preparing your pre-screening questions…

Expert Care in Boston

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

Apply for This Boston Location

Check if you qualify for this acute myeloid leukemia clinical trial in Boston, MA

Secure & Confidential

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

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA 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 Boston site if eligible
  4. 4Begin participation

About This Acute Myeloid Leukemia Study in Boston

The purpose of this research study is to test the safety and to explore the effectiveness of infusing cytokine- induced memory-like (CIML) natural killer (NK) cells in combination with Interleukin-2 (IL-2) and standard-of-care venetoclax as a treatment for Acute Myeloid Leukemia (AML). Names of the study therapies involved in this study are: * Lymphodepleting therapy with Fludarabine and Cyclophosphamide prior to CIML NK cell infusion * CIML NK (a cellular therapy) * IL-2 (a recombinant, human glycoprotein) * Venetoclax (a selective inhibitor of BCL-2 protein)

Sponsor: Dana-Farber Cancer Institute

Who Can Participate

Inclusion Criteria

for Trial Enrollment (Screening Visit #1):
Diagnosis of acute myeloid leukemia (AML)
Age ≥ 18 years old
At time of screening patient is being treated with HMA(azacitidine or decitabine) + venetoclax therapy and has received at least 1 cycle of HMA (azacitidine or decitabine) + venetoclax. Patients can have received other lines of therapy prior to HMA + venetoclax therapy including prior chemotherapy and any prior stem cell transplant, provided that the stem cell transplant is \> 6 months prior with no ongoing need for immunosuppressive therapy for active graft-versus-host disease.
Presence of molecular risk factors for relapse with continued HMA + venetoclax therapy as defined by any of the following present at the time of diagnosis or start of HMA + venetoclax therapy (these do not need to be present at the time the screening BM biopsy):
2022 ELN adverse risk karyotype: t(6;9)(p23.3;q34.1)/DEK::NUP214; t(v;11q23.3)/KMT2A-rearranged; t(9;22)(q34.1;q11.2)/BCR::ABL1; t(8;16)(p11.2;p13.3)/KAT6A::CREBBP; inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)/ GATA2, MECOM(EVI1), t(3q26.2;v)/MECOM(EVI1)-rearranged; -5 or del(5q); -7; Complex karyotype, monosomal karyotype
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD
ECOG performance status ≤2 (see Appendix A)
Participants must meet the following organ function as defined below:
Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \< 3 x ULN)
AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN
creatinine clearance ≥ 45 mL/min; calculated by the Cockcroft Gault formula
oxygen saturation ≥ 90% on room air
left ventricular ejection fraction ≥ 40%
Negative pregnancy test for women of childbearing potential only.
The effects of CIML NK cells and IL-2 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) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 4 months after the last IL-2 dose administration.
Participants with current symptoms of cardiac disease should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)
Subjects must be able to swallow pills.
No laboratory evidence of ongoing hemolysis in opinion of investigator (demonstration of hemolysis should include a haptoglobin level that is below assay).

Exclusion Criteria

for Trial Enrollment (Screening visit #1)
Prior allogeneic stem cell transplant, organ transplant or donor lymphocyte infusion (DLI), CAR-T cell or NK cell therapy
Persisting Grade \> 1 non hematologic toxicity related to prior therapy; however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease disease requiring any steroids \>\> the equivalent dose of 10 mg of prednisone or other immunosuppressive therapies at the time of this screening visit (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). Patients with Hashimoto's thyroiditis are eligible to go on study.
Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by Flu/Cy chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.
HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow suppressive therapy.
Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after conditioning therapy.
Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1. History of other malignancy and have had complete remission of disease for at least 2 years; 2. Diagnosed and treated within the past 2 years for: nonmetastatic melanoma, surgically resected (not needing systemic chemotherapy) squamous cell carcinoma of skin and nonmetastatic prostate cancer not needing systemic chemotherapy.
History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in study.
Participants who are receiving any other investigational agents for this condition
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Prior history of Grade 2 or higher hemolytic anemia (≥ 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause. Inclusion Criteria to Start Investigational Treatment Plan (Screening visit #2)
Patient was eligible for protocol per section 3.1.
Repeat bone marrow biopsy at this time shows a complete remission (CR) or complete remission with incomplete count recovery (CRi) or morphologic leukemia free state (MLFS) (\< 5% blasts) but with presence of measurable residual disease (MRD+). MRD can be determined by either flow cytometry, next generation sequencing or PCR. Patients with only persistent DNMTA, TET2 or ASXL1 mutations will not qualify as MRD+ as these DTA mutations without other comutations are associated with clonal hematopoiesis. OR
Repeat bone marrow biopsy at this time shows 5-19% residual myeloblasts in the bone marrow by either bone marrow aspirate or core biopsy.
Confirmed haploidentical or fully HLA-matched related donor that is willing and eligible for non-mobilized collection.
ECOG performance status ≤2 (see Appendix A)
Participants must meet the following laboratory and organ function as defined below:
Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \< 3 x ULN)
AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN
creatinine clearance ≥ 45 mL/min; calculated by the Cockcroft Gault formula
oxygen saturation ≥ 90% on room air
No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)
Negative pregnancy test for women of childbearing potential only.
Subjects must be able to swallow pills. Exclusion Criteria to Start Investigational Treatment Plan (Screening visit #2)
No live vaccines within the last 6 months.
No ongoing or active infections.
Moderate/strong inhibitors of CYP3A except of antifungal medications (such as posaconazole, voriconazole) which the patient is on and the dose of venetoclax has already been adjusted. These are excluded as moderate/strong inhibitors of CYP3A induce higher drug levels of venetoclax which in turns carry the risk of CIML NK cell elimination.
The presence of donor-specific antibodies (DSAs) with mean fluorescence intensity (MFI) \>1000 using a standard assay in subjects who do not receive a desensitization protocol prior to and during stem cell transplant. Criteria to Receive Lymphodepletion on Day -5
Adequate organ function within 24 hours of lymphodepletion as defined below:
Direct bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \< 3 x ULN)
AST (SGOT)/ALT (SGPT): ≤ 3 x institutional ULN
No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with lymphodepletion, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)
No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.
No live vaccines within the last 6 months Criteria to Receive CIML NK Infusion
Adequate organ function within 24 hours of NK cell infusion as defined below:
Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \< 3 x ULN)
AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN
Creatinine clearance ≥ 45 mL/min; calculated by the Cockcroft Gault formula
No Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).
No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)
No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.
No systemic steroid therapy (oral or IV) of \> 10mg prednisone or equivalent dose of other steroid agent on the day of NK cell infusion If any of the above criteria are noted at these time points, please discuss with PI the benefits/risks of proceeding with the CIML infusion and document rationale for course of action taken in study regulatory binder. However, patient may still receive CIML NK infusion if relevant parameters are reviewed and both PI and IND holder agree with proceeding. If inclusion/exclusion criteria are not met on planned day of CIML NK cell infusion, the NK cell infusion may be delayed for up to 24 hours to enable inclusion criteria to be met. Criteria to Receive Venetoclax
Adequate organ function within 24 hours of venetoclax initiation as defined below:
Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \< 3 x ULN)
AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN
No Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).
No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with venetoclax administration, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, severe ongoing tumor lysis syndrome)
No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.
No live vaccines within the last 6 months

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 (NCT06152809) 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 (NCT06152809) 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.

More Leukemia Trials in Boston, MA

See all leukemia clinical trials recruiting in Boston — not just this study.

Browse Leukemia Trials in Boston →

Browse More Trials by Condition

Leukemia TrialsAcute Myeloid Leukemia TrialsHeart Attack TrialsMyocardial Infarction TrialsOsteogenesis Imperfecta TrialsAll Conditions →

Ready to Join in Boston?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Boston, MA