Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors
- Conditions
- Interventions
- Registration Number
- NCT06625190
- Lead Sponsor
- University of Florida
- Brief Summary
Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to s...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 27
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Patients ≤ 25 years of age
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Relapsed/Refractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer >20% chance of cure with the following diseases:
- neuroblastoma (high risk with relapsed or refractory disease),
- relapsed/refractory rhabdomyosarcoma,
- relapsed/refractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),
- High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,
- Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor
- relapsed/refractory bone tumors: osteosarcoma and Ewing sarcoma/PNET, or
- other high-risk solid tumors with <10% expected survival with conventional treatment.
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Subjects must not have more than one active malignancy at the time of enrollment. (Subjects 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 [as determined by the treating physician and approved by the PI] may be included.)
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Haplo-identical related donor (at least one full haplotype must be matched).
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Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients >16 years of age and Lansky scores for patients ≤16 years of age
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Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:
- Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.
- Renal: Creatinine clearance or radioisotope GFR ≥60 mL/min/1.73 m2 or a serum creatinine based on age/gender
- Cardiac: Ejection fraction of ≥ 40% by echocardiogram or radionuclide scan (MUGA).
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Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures
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Individuals of childbearing potential (IOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for one year following transplantation to minimize the risk of pregnancy. Prior to study enrollment, individuals of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factor for an unintentional pregnancy.
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Subjects with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for one year following stem cell transplantation.
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Patients with documented uncontrolled infection at the time of study entry are not eligible.
a. Uncontrolled infection is patient without treatment antimicrobials and/or demonstrating progression despite antimicrobials
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Demonstrated lack of compliance with medical care, as determined by the treating physician.
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Patients who have received an allogeneic HSCT within 6 months.
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Patients who do not have an eligible allogeneic donor available.
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Patients with a life expectancy <3 months
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Patients not meeting inclusion criteria for organ function.
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Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one year after transplantation.
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Females who are known to be pregnant or breastfeeding.
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History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
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Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description alpha/beta T cell and CD19+ B cell depleted stem cell graft with zoledronic acid Miltenyi CliniMACS Prodigy ® system - alpha/beta T cell and CD19+ B cell depleted stem cell graft with zoledronic acid Zoledronic acid -
- Primary Outcome Measures
Name Time Method Disease-free survival rate 1 year post-transplant Determine the disease-free survival rate at 1 year post-transplant
Incidence of aGVHD 2 years post-transplant Determine the incidence of grade II-IV acute graft versus host disease (aGVHD)
- Secondary Outcome Measures
Name Time Method Disease-free survival rate 2 years post-transplant Determine the disease-free survival rate at 2 years post-transplant
Overall survival rate 2 years post-transplant Determine the overall survival rate at 2 years post-transplant