Rochester, NYNCT03739502Now EnrollingIRB Ready

AML Clinical Trial in Rochester, NY

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

Sponsored by University of Rochester

Quick Self-Assessment

See if you qualify for this Rochester location

Preparing your pre-screening questions…

Expert Care in Rochester

Access aml specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related aml treatment provided free

Apply for This Rochester Location

Check if you qualify for this aml clinical trial in Rochester, NY

Secure & Confidential

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

Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for NY 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 Rochester site if eligible
  4. 4Begin participation

About This AML Study in Rochester

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).

Sponsor: University of Rochester

Who Can Participate

Inclusion Criteria

Voluntary written informed consent
Patients who are considered for allogeneic transplantation based on their disease risk (see below) but lack matched sibling or unrelated donors or who are unable to proceed to allogeneic transplant within 8 weeks, will be considered for UCB transplantation on this study. Only patients for whom RIC will be considered are eligible. RIC is considered in those older than 45 or younger than 45 with Hematopoietic Cell Transplant (HCT) Comorbidity Index of 3 or higher (HCT) Comorbidity Index can be calculated using the following link: http://www.hctci.org/Home/Calculator
Patients with acute myeloid leukemia (AML) in CR1 that is not considered favorable-risk (favorable risk is defined as patients with t(15;17)(q22;q21), t(8;21)(q22;q22), inv(16)(p13q22)/t(16;16)(p13;q22), NPM1 mutation without FLT3-ITD, and double-mutated CEBPA58,59), AML in CR2 or subsequent CR, high-risk acute lymphoblastic leukemia (ALL) in CR1, or ALL in CR2 or higher, biphenotypic leukemia defined as coexpression of B-lymphoid and myeloid markers or T-lymphoid and myeloid markers in the blast population60or undifferentiated leukemia in ≥CR1. Myelodysplatic syndrome (MDS)/myeloproliferative neoplasm (MPN) patients with less than 10% bone marrow blasts and no peripheral blood blasts on pre-transplant bone marrow aspirate/biopsy are considered for FluCyTTBI regimen. Chemotherapy sensitive (achievement of at least a partial response according to Lugano classification61) Hodgkin's disease (HD) that relapsed following high-dose therapy. Chemotherapy sensitive (achievement of at least a partial response according to Lugano classification) non-Hodgkin's lymphoma (NHL) patients who relapsed post-high-dose therapy and autologous transplantation. Subjects should be enrolled within 30 days of transplant.
For ALL, high-risk features are defined using modified Hoelzer risk criteria62, these criteria are:
High white blood cell count at diagnosis (ie, \>30,000/microL in B-ALL or \>100,000/microL in T-ALL).
Clonal cytogenetic abnormalities - t(4;11), t(1;19), t(9;22), or BCR-ABL gene positivity.
Progenitor-B cell immunophenotype (eg, blasts expressing membrane CD19, CD79a, and cytoplasmic CD22).
Length of time from start of induction therapy to attainment of CR greater than four weeks.
Older age - \>60 years old is high risk, 30 to 59 years old is intermediate risk.
MRD - a post-remission bone marrow MRD level ≥10-3 by molecular tests.
Subjects must be ≥ 18 years old and ≤ 70 years old
Karnofsky performance status (KPS) of ≥ 70% (Appendix A).
Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include:
ALT, AST: \< 4x IULN
Total bilirubin: ≤ 2.0 mg/dL
Creatinine: ≤ 1.5 x ULN
EF measured by 2D-ECHO or MUGA scan of ≥ 45%
FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin).
EKG with no clinically significant arrhythmia.
Patients should have New York Heart Association (NYHA) Functional Classification, class -1 (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina pain) or class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or angina pain).
Patients should be evaluated for fitness for HBO by a hyperbaric oxygen trained medical professional who is not part of the study team prior to starting preparative regimen.
Women of child-bearing potential should have a negative urine pregnancy test within 4 weeks of starting preparative regimen.
Women of child-bearing potential and men with partners of child-bearing potential 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 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.
A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria

Pregnant or breastfeeding
Severe chronic obstructive pulmonary disease requiring oxygen supplementation
History of spontaneous pneumothorax
Active ear/sinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, throat provider.
Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant.
Prior chest surgery requiring thoracotomy or direct chest irradiation.
Recent of sinus or ear surgery, excluding myringotomy or ear tubes (within the last 5 years).
Claustrophobia
Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen.
History of seizures
No active tobacco use 72 hours prior to transplant until complete transplant recovery.

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 Rochester?

Yes, this clinical trial (NCT03739502) has an active research site in Rochester, NY 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 Treatment Options in Rochester, NY

If you're searching for aml treatment options in Rochester, NY, this clinical trial (NCT03739502) 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 Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced aml 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 clinical trials near you to find additional studies recruiting in your area.

More Leukemia Trials in Rochester, NY

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

Browse Leukemia Trials in Rochester →

Browse More Trials by Condition

Leukemia TrialsAcute Myeloid Leukemia TrialsAll Conditions →

Ready to Join in Rochester?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Rochester, NY