临床试验/NCT03187756

NCT03187756终止2 期

Phase II Study of Nonmyeloablative Peripheral Blood Stem Cell Transplant With High-dose Posttransplantation Cyclophosphamide in Hematopoietic Malignancies Including Those That Are Challenging to Engraft

NYU Langone Health1 个研究点分布在 1 个国家目标入组 6 人开始时间: 2017年6月2日最近更新: 2020年3月27日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: NYU Langone Health
入组人数: 6
试验地点: 1
主要终点: Event Free Survival (EFS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open label phase II single arm study of peripheral blood stem cell transplantation and posttransplantation cyclophosphamide, using HLA full match or haploidentical related donors, in hematological malignancies including those difficult to engraft. The objective of this study is to evaluate the safety and feasibility in nonmyeloablative, partially HLA-mismatched or HLA-matched PBSC transplant from haploidentical donors or fully matched donors with post-grafting immunosuppression that includes high-dose cyclophosphamide, tacrolimus, and Mycophenolate mofetil (MMF).

详细描述

Primary Objective Estimate event free survival (EFS) (relapse, progression, or death) rate one year after transplant.

Secondary Objectives:

Estimate the cumulative incidences of severe acute grade III or higher GVHD, chronic GVHD (overall and by extent)
Estimate the cumulative incidence of systemic steroid initiation,
Summarize the graft failure frequency,
Summarize the kinetics of neutrophil and platelet recovery, and kinetics of donor chimerism in unsorted and CD3+ sorted peripheral blood.
Summarize major toxicities and complications associated with the transplantation procedure selected toxicities.

Exploratory Objectives:

Explore the association between the amount of donor T cell chimerism at ~ Day 28 and patient/graft characteristics (e.g., prior therapies, graft cell dose) and transplantation outcomes (sustained engraftment, relapse or progression, GVHD).

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: 18 Years 至 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•The following are eligibility for study entry and transplantation.
•Presence of a suitable related, HLA-haploidentical or HLA-matched stem cell donor
•The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB
•A minimum match of 5/10 is therefore required for related donors, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype.
•Eligible diagnoses:
•Myelodysplastic syndrome (MDS) including chronic myelomonocytic leukemia [CMML] with at least one poor risk factor
•No active extramedullary leukemia or known active CNS involvement by malignancy. Such disease treated into remission is permitted.
•Any previous autologous HSCT must have occurred at least 3 months prior to start of conditioning
•No previous allogeneic HSCT
•Adequate end-organ function Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
•ECOG performance status < 2 or Karnofsky or Lansky score >
•Age > 18 years and older.
•Not pregnant or breast-feeding.
•No uncontrolled infection.
•Eligible diagnoses:
•Myelodysplastic syndrome (MDS) including chronic myelomonocytic leukemia [CMML] with at least one of the following poor-risk features
•SLL or CLL with 17p deletion, or with progression < 6 months after second or greater treatment regimen. Must have the following to be an acceptable candidate as well:
•< 20% of bone marrow cellularity involved by SLL/CLL (to lower risk of graft rejection)
•No lymph nodes > 5 cm in any dimension
•No massive splenomegaly, defined as > 6 cm below the left costal margin
•T-cell PLL in PR or better prior to transplantation. Must also have < 20% of bone marrow cellularity involved by PLL (to lower risk of graft rejection).
•Interferon- or tyrosine kinase-refractory CML in first chronic phase, TKI-intolerant CML in first chronic phase, or CML in second or subsequent chronic phase
•Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis)
•o Intermediate-2 or High risk score by DIPSS Plus is required for a diagnosis of myelofibrosis
•Multiple myeloma or plasma cell leukemia with a PR or better to the last treatment regimen, based on the International Myeloma Working Group (IMWG) criteria.49
•Hematologic malignancy in complete remission with minimal residual disease (MRD) non detectable OR detectable by conventional cytogenetics, FISH, flow cytometry, or molecular testing or hematologic malignancies in partial remission
•Donor eligibility
•Donors must be either:
•HLA-haploidentical or HLA-identical relatives of the patient based on allele or allele group level typing as defined in Section 4.
•Medically fit to and willing to donate
•Lack of recipient anti-donor HLA antibody
•Has not donated blood products to patient

排除标准

•Any individual that does not meet the eligibility criteria for transplantation or donor eligibility will not be a part of this trial.

研究组 & 干预措施

Cyclophosphamide

Experimental

干预措施: Cyclophosphamide (Drug)

结局指标

主要结局

Event Free Survival (EFS)

时间窗: One Year

Estimate the one year after transplantation event free survival (EFS) rate using a Kaplan-Meier curve with a 90% confidence interval. An event for EFS is defined as the first of any of the following failures: relapse or disease progression or death from any cause

次要结局

Number of Participants With Chronic GVHD and Grades I-IV GVHD(1 year)
Number of Major Toxicities and Complications Associated With Transplantation Procedure(1 year)
Cumulative Incidences of Systemic Steroid Initiation(1 year)
Graft Failure Frequency(1 year)
Time to Neutrophil Recovery(1 year)
Time to Platelet Recovery(1 year)

研究者

发起方

NYU Langone Health

申办方类型

Other

责任方

Sponsor

研究点 (1)

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