Is NCT06680661 recruiting in Cleveland, OH?

Yes, NCT06680661 is currently recruiting participants at its Cleveland, OH location. This acute myelogenous leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myelogenous leukemia clinical trial in Cleveland?

To join this clinical trial in Cleveland, 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 Cleveland 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 Myelogenous Leukemia Clinical Trial in Cleveland, OH

About This Acute Myelogenous Leukemia Study in Cleveland

The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT. Participants will: * Partake in exams, tests, and procedures as part of usual cancer care. * Partake in conditioning, which is the treatment that is given before a transplant. * Have a cord blood transplant. * Partake in radiation following the transplant.

Sponsor: Leland Metheny

Who Can Participate

Inclusion Criteria

Patients with the following hematologic malignancies:

Acute myelogenous leukemia (AML): High-risk and intermediate-risk AML including:

Antecedent hematological disease (e.g., myelodysplasia (MDS))

Treatment-related leukemia

Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, complex cytogenetics)

Induction failure or 1st relapse with \< 10% blasts in the marrow

Acute lymphoblastic leukemia (ALL):

High-risk CR1 including:

Poor-risk cytogenetics (e.g., Philadelphia chromosome t(9;22)or 11q23 rearrangements)

Philadelphia chromosome-like ALL

Presence of minimal disease by flow cytometry after 2 or more cycles of chemotherapy

No CR within 4 weeks of initial treatment

Induction failure with \< 10% blasts in the marrow

Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system or treatment related MDS.

Bi-phenotypic or mixed-phenotypic acute leukemia in:

Induction failure or 1st relapse with \< 10% blasts in the marrow.

Chronic Myelogenous Leukemia (CML) in second chronic phase after accelerated or blast crisis.

Chronic Myelomonocytic Leukemia (CMML)

Hodgkin's Lymphoma that is relapsed or refractory

Age \> or equal to 18 years, \< or equal to 70yrs

KPS \> or equal to 80 for Flu/Cy/Thio/TBI; KPS \> 60 for Flu/Treo/TBI

Patients without a suitable HLA-matched related or unrelated donor

Patient with the following CB units:

At least two 4-8/8 HLA high resolution matched CB units. Both must have a cell dose of 1.5x107 TNC/kg each and 1.5x105 CD34+/kg

A minimum of 1 CB unit as back up.

Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia, and CNS lymphoma including standard intrathecal chemotherapy and/or radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Subjects must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.

Subjects must have the ability to understand and the willingness to sign a written informed consent document.

For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for 12 months after the last dose of abatacept.

A woman is considered to be of childbearing potential if she is \< 60 years old, postmenarcheal, has not reached a postmenopausal state (\< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).

Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, as defined below:

With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for 12 months after the last dose of abatacept. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 12 months after the last dose of abatacept.

The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria

Patients with inadequate Organ Function as defined by:

Creatinine clearance \< 50ml/min

Bilirubin \> 2X institutional upper limit of normal unless Gilbert syndrome

AST (SGOT) \> 3X institutional upper limit of normal

ALT (SGPT) \> 3X institutional upper limit of normal

Pulmonary function: DLCOc \< 60% normal

Cardiac: left ventricular ejection fraction \< 50

Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.

Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.

Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Presence of donor-specific antibodies against chosen graft source.

Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) \> 5.

Prior autologous or allogenic stem cell transplant within the preceding 12 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 Cleveland?

Yes, this clinical trial (NCT06680661) has an active research site in Cleveland, OH 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 Myelogenous Leukemia Treatment Options in Cleveland, OH

If you're searching for acute myelogenous leukemia treatment options in Cleveland, OH, this clinical trial (NCT06680661) 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 Cleveland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute myelogenous 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 myelogenous leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myelogenous Leukemia Clinical Trial in Cleveland, OH

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