An open, multi-center, randomized trial comparing haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies
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 acute leukemias and MDS who are eligible to haploidentical HSCTs. 2 groups of patients will be enrolled with 116 in each group. The clinical criteria including survival, relapse, transplantation-related mortality will be monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
232
4 mg/m2/day administered IV day -10 through -9.
3.2 mg/kg/day administered IV day -8 through -6.
1.8 g/m2/day administered IV day -5 through -4.
Xiangya Hospital Central South University
Changsha, China
Xinqiao Hospital, State Key Laboratory of Trauma and Chemical Poisoning, Army Medical University
Chongqing, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
Zhejiang Provincial People's Hospital
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
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250mg/m2 once administered orally on day -3.
Between 6mg/kg total dose administered IV day -5 through -2 AND 7.5mg/kg total dose administered IV day -5 through -2.
Day 0
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.
500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.
15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.
Hangzhou, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
The Affiliated People's Hospital of Ningbo University
Ningbo, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Time frame: 2 years
Cumulative incidence of total acute and grade II-IV acute 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.
Time frame: 180 days
Cumulative incidence of total and and moderate-severe 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.
Time frame: 2 years