NCT05794880招募中不适用
Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluate incidence and extent of aGVHD and engraftment in patients receiving alpha/beta T cell depleted and CD19+ B cell depleted stem cell transplant with individualized ALC-based dosing of ATG
研究概览
简要总结
This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age < 25 years. Both genders and all races eligible.
- •Disease eligibility
- •Acute myeloid leukemia, primary or secondary - Disease status: MRD negative (flow MRD ≤ 0.1%)
- •Myelodysplasia
- •Acute lymphoblastic leukemia - Disease status: MRD negative
- •Chronic myelogenous leukemia - Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase
- •Mixed lineage or biphenotypic acute leukemia- Disease status: MRD negative
- •Lymphoblastic lymphoma - Disease status: in remission
- •Burkitt's lymphoma/leukemia - Disease status: in remission
- •Lymphoma after relapse - Disease status: in remission
- •Other malignant hematologic diseases in remission (to be approved by PI)
- •Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1)
- •Evaluation of organ status as per MCW BMT SOP
- •Infectious disease criteria: No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.
- •Signed consent by parent/guardian or able to give consent if ≥18 years.
- •Negative pregnancy test for patients capable of childbearing potential
- •Sexually active patients capable of child-bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment. Sexually active men must agree to use barrier contraceptive for the duration of treatment.
- •Donor Eligibility:
- •Unrelated donor meets National Marrow Donor Program criteria for donation
- •Infectious disease testing
- •MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases.
- •Only Peripheral blood stem cells will be used for stem cell source on this study therefore donor must be willing to undergo G-CSF mobilization and stem cell apheresis. Donor matching. High resolution typing at all loci to be performed.
- •Unrelated Donor:
- •a. HLA typing of at least 10 alleles is required. Donor must be matched at 9/10 or 10/10 alleles (HLA A, B, C, DRB1, DQB1).Donor and collection center willing to undergo mobilization and apheresis
- •Haploidentical Related Donor:
- •Haploidentical parent or other related donor: Minimum match level full haploidentical (at least 5/10; HLA A, B, C, DRB1, DQB1 alleles), but use of haploidentical donors with extra matches (e.g. 6, 7, or 8/10) encouraged.
排除标准
- •Patients who do not meet disease, organ, or infectious criteria.
- •No suitable donor
- •Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants
- •Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease other than is specified in the protocol. Maintenance or other post-HCT therapy can be considered after discussion with the study PI.
- •Participating in a concomitant Phase 1 or 2 study involving treatment of disease
- •Active malignancy other than eligible disease specified in the protocol. Patients with prior malignancy can be eligible as long as at least 1 year post treatment for that malignancy.
研究组 & 干预措施
Alpha/Beta T cell depletion (TCD) plus CD19+ depletion
Experimental
Alpha beta T cell and B cell depleted allogeneic transplantation with individualized dosing of ATG for patients with hematologic malignancies
干预措施: Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi) (Device)
结局指标
主要结局
Evaluate incidence and extent of aGVHD and engraftment in patients receiving alpha/beta T cell depleted and CD19+ B cell depleted stem cell transplant with individualized ALC-based dosing of ATG
时间窗: 1 year
次要结局
- Evaluate incidence of chronic GVHD(5 years)
- Assess incidence of viral infections(2 years)
- Evaluate time to platelet engraftment(1 years)
- Evaluate incidence of relapse/progressive disease(2 years)
- Evaluate incidence of treatment-related mortality (TRM).(2 years)
- Evaluate overall and relapse free survival (RFS) at 1 year(1 years)
研究者
Amy Moskop
Assistant Professor
Medical College of Wisconsin
研究点 (2)
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