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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04547049
Other study ID # NFD-001
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 1, 2020
Est. completion date December 31, 2025

Study information

Verified date February 2023
Source First Affiliated Hospital of Zhejiang University
Contact Yi Luo, MD
Phone 86-13666609126
Email luoyijr@zju.edu.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An open, multi-center, randomized trial comparing haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies


Description:

This is an open, multi-center, randomized trial comparing the clinical outcomes of haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies. This study is indicated for patients with hematological malignancies including ALL, AML, MDS and NHL who are eligible to haploidentical HSCTs. 2 groups of patients will be enrolled with 80 in each group. The clinical criteria including survival, relapse, transplantation-related mortality will be monitored.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 31, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 14 Years to 60 Years
Eligibility Patient Inclusion Criteria: - Patient age 14-60 years - Absence of a suitable HLA identical related or unrelated hematopoietic stem cell donor - Absence of a suitable partially HLA-mismatched (haploidentical), first-degree related donor aged between 18 and 50 - Presence of both HLA haploidentical young non-first-degree (age = 40) and older first-degree (age >50) donors Eligible diagnoses: AML(excluding APL) with at least one of the following: - median- or high- risk according to the WHO prognostic stratification system - failure to achieve CR after 2 cycles of induction chemotherapy - AML arising from MDS or a myeloproliferative disorder, or secondary AML - patients in CR2 or beyond, with <5% bone marrow blasts before HSCT ALL in remission, defined as <5% bone marrow blasts morphologically MDS with at least one of the following: - IPSS score of INT-2 or greater - IPSS score of INT-1 with life-threatening cytopenias, including those generally requiring greater than weekly transfusions NHLs (including diffuse large B-cell lymphoma, lymphoblastic lymphoma, Burkitt lymphoma, peripheral T-cell lymphoma, and NK or NK-T cell lymphoma) which are relapsed/refractory OR in CR2 or beyond - Adequate end-organ function - ECOG performance status < 2 - No other contraindications for HSCT - Signature of the informed consent Patient Exclusion Criteria: - Availability of suitable HLA identical related or unrelated hematopoietic stem cell donors - Availability of suitable partially HLA-mismatched (haploidentical), first-degree related donor aged between 18 and 50 - Presence of uncontrolled bacterial, viral, or fungal infection - Patients with severe heart, lung, liver and kidney insufficiency - HIV-positive patients - Women of childbearing potential who are pregnant (ß-HCG+) or breast feeding - Patients with a psychiatric history - ECOG performance status = 3 - Patients with malignancies other than the primary disease - Refusal to sign the informed consent Donor Inclusion Criteria: - The donor and recipient must be HLA haploidentical - Meets institutional selection criteria and medically fit to donate - Lack of recipient anti-donor HLA antibody Donor Exclusion Criteria: - The donor and recipient are HLA identical - Has not donated blood products to recipient

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cytarabine
4 mg/m2/day administered IV day -10 through -9.
Busulfan
3.2 mg/kg/day administered IV day -8 through -6.
Cyclophosphamide
1.8 g/m2/day administered IV day -5 through -4.
Me-CCNU
250mg/m2 once administered orally on day -3.
Rabbit antithymocyte globulin
1.5mg/kg/day administered IV day -5 through -2.
Procedure:
Allogeneic HSCT
Day 0
Drug:
Cyclosporin A
2.5 mg/kg/day administered intravenously from day -7, target: 200-300ng/mL. Usually tapered during the second month, and ended in complete withdrawal during the ninth month after transplantation.
Mycophenolate Mofetil
500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.
MTX
15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.

Locations

Country Name City State
China Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University Hangzhou
China The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou
China The Second Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou
China Zhejiang Provincial People's Hospital Hangzhou
China Jinhua Hospital of Zhejiang University Jinhua
China Ningbo Hospital of Zhejiang University Ningbo
China The Affiliated People's Hospital of Ningbo University Ningbo
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative incidence of transplant-related nonrelapse mortality (NRM) All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. 2 years
Secondary Overall survival (OS) All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. 2 years
Secondary Progression-free survival (PFS) All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. 2 years
Secondary Cumulative incidence of disease relapse or progression All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. 2 years
Secondary GVHD-free, relapse-free survival (GRFS) All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression.
GRFS is defined as survival with no evidence of relapse/progression, grade III to IV aGVHD, and systemic therapy-requiring cGVHD.
2 years
Secondary Cumulative incidence of acute grade II-IV GVHD Date of symptom onset, maximum clinical grade, and dates and types of treatment will be recorded. Dates of symptom onset of grade II or higher acute GVHD and grade III-IV acute GVHD will be recorded. 2 years
Secondary Cumulative incidence of chronic GVHD Date of symptom onset, maximum clinical grade, and dates and types of treatment will be recorded. Dates of symptom onset of chronic GVHD and severe chronic GVHD will be recorded. 2 years
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