Is NCT06315309 recruiting in Birmingham, AL?

Yes, NCT06315309 is currently recruiting participants at its Birmingham, AL location. This gvhd,acute clinical trial is actively enrolling qualified participants.

How do I join the gvhd,acute clinical trial in Birmingham?

To join this clinical trial in Birmingham, 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 Birmingham 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.

GVHD,Acute Clinical Trial in Birmingham, AL

About This GVHD,Acute Study in Birmingham

The purpose of this study is to test whether the combination of the drugs called tacrolimus (Tac), methotrexate (MTX) and new dosing strategy of another drug called (rabbit Anti-thymocyte Globulin \[ATG\]) will help prevent the development and/or improve severity of acute and/or chronic GVHD.

Sponsor: University of Alabama at Birmingham

Who Can Participate

Inclusion Criteria

Adult male or female, age 18-60 years

Patients must have a related or unrelated peripheral blood stem cell donor. Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. Unrelated donor must be 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donor must be willing to donate peripheral blood stem cells and be medically eligible to donate stem cells according to NMDP criteria.

A candidate for Myeloablative preparative regimen, based on age ≤ 60, or HCT-CI of ≤ 4, and considered by the treating physician to be a candidate for such regimen.

Cardiac function: Ejection fraction ≥ 45%

Calculated creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight).

Pulmonary function: DLCO ≥50% (adjusted for hemoglobin) and FEV1≥50%

Liver function: total bilirubin \< 1.5x the upper limit of normal and ALT/AST \< 2.5x the upper normal limit. Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value up to \<3mg/dl.

Female subjects (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two effective methods of contraception (hormonal contraception and male partner to use condom) or agree to complete abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.

Male subjects (even if surgically sterilized), of partners of women of childbearing potential must agree to practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.

Karnofsky performance status KPS ≥ 80 (Appendix B)

Patients must have a diagnosis of one of the following: A-Acute myeloid leukemia (AML) in complete remission CR 1 with intermediate or high risk for relapse as defined by ELN 2022 criteria(Dohner et al., 2022) (appendix C), or deemed to be at high risk for relapse by treating physician, based on, therapy related, or extra medullary presentation. B-AML in \>CR1. C-Myelodysplastic syndrome (MDS) with IPSS-M ≥ intermediate-low.(Bernard et al., 2022; Mohty et al., 2022) D- Chronic myeloproliferative disorder (ET, PV, myelofibrosis) with bone marrow blasts \> 5% and/or other evidence of progression to acute leukemia or Int or high-risk disease by MIPPS v2 score.(Ali et al., 2019; Guglielmelli et al., 2018) E- CMML especially those with high-risk features based in: The CMML-specific prognostic scoring system with molecular features (CPSS-Mol) - high risk and intermediate-2 risk, Mayo molecular model - high risk and Intermediate-2 risk, Groupe Francophone des Myélodysplasies (GFM) - high risk and selected patients with intermediate risk.(Elena et al., 2016; Itzykson et al., 2013; Patnaik et al., 2014). F- Acute lymphoblastic leukemia (ALL) in CR1 with high risk for relapse

B-cell ALL: High white blood cell count at diagnosis (ie, \>30,000/µl), Clonalcytogenetic abnormalities - t(4;11), t(1;19), t(9;22), or BCR-ABL gene positivity, BCR-ABL1-like (Ph-like) gene signature, progenitor-B cell immunophenotype (eg, blasts expressing membrane CD19, CD79a, and cytoplasmic CD22, but not CD10), Length of time from start of induction therapy to attainment of CR greater than four weeks, and minimal residual disease (MRD) post-remission bone marrow MRD+.(Akabane \& Logan, 2020; Lafage-Pochitaloff et al., 2017)

T-cell ALL: Failure to achieve CR after one induction, MRD\> 1X 10-4 after 2 courses of induction, Presenting WBC \> 100 X 109/L, complex cytogenetics ≥5,early T-cell Precursor ALL, poor risk genetics including lack of NOTCH1 ith/FBXW7 or presence of N-RAS \& K-RAS, EZH2 and age\>40 years.(Marks \& Rowntree, 2017) G- ALL in \>CR1

The subject is willing and able to sign informed consent and abide by the protocol requirements.

Exclusion Criteria

Autologous hematopoietic stem cell transplant \< 3 months prior to enrollment.

Patients with florid residual AML with \> 5% blast in the marrow or circulating blast in the peripheral blood are not eligible for this study.

Previous allogeneic stem cell transplant.

Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities.

Known hypersensitivity to the study agent (ATG)

Received any investigational drugs within the 14 days prior to the first day of transplant conditioning

Pregnant and/or breastfeeding

Evidence of HIV infection or known HIV positive serology.

Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).

Non-hematologic malignancy within prior three (3) years, with the exception of squamous cell or basal cell skin carcinoma.

Participation in another clinical study with an investigational product during the last 28 days.

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 Birmingham?

Yes, this clinical trial (NCT06315309) has an active research site in Birmingham, AL 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.

GVHD,Acute Treatment Options in Birmingham, AL

If you're searching for gvhd,acute treatment options in Birmingham, AL, this clinical trial (NCT06315309) 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 Birmingham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced gvhd,acute 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 gvhd,acute clinical trials near you to find additional studies recruiting in your area.

GVHD,Acute Clinical Trial in Birmingham, AL

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