Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
Recruiting
NCT Number: NCT06512519
Second Haplo-transplantation for Graft Failure
Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. We recently reported encouraging outcomes using a novel method (haploidentical transplantation from a different donor after conditioning with fludarabine and cyclophosphamide). However, the study was performed in single-center and with very small sample size. Therefore, it should be further validated via multicenter study. In this multi-center study, we aim to further evaluate the safety and efficacy of this protocol.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
14 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 1. Primary disease: hematological malignancies (AML, CML, MDS, lymphoma, etc.); 2. Graft failure after the first haploidentical stem cell transplantation; 3. Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years.
Exclusion criteria
- 1. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%<50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score>2; 5. Expected life time<30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,
Treatment and study plan
second allogeneic stem cell transplantation
Other- Change another donor if possible
- Conditioning regimen: fludarabine (30mg/m2/day, days -6 to -2 ), cyclophosphamide (1g/m2/day, days -5 to -4)
- GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg -1d, +4d, +15d)
Primary outcomes
-
Engraftment of neutrophils
Time frame: 28 days after second transplantation
Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.
Secondary outcomes
-
Engraftment of Platelet
Time frame: 100 days after second transplantation
Platelet engraftment was defined as the first of 7 consecutive days that platelet counts ≥20 × 10^9/L in the absence of platelet transfusion
-
TRM at 28 day
Time frame: 28 days after second transplantation
treatment-related mortality (TRM) was defined as death from any cause other than relapse
-
TRM at 100 day
Time frame: 100 days after second transplantation
treatment-related mortality (TRM) was defined as death from any cause other than relapse
-
GVHD
Time frame: Participants will be followed for an expected average of 1 year
Both acute and chronic GVHD was diagnosed and graded according to international criteria.
-
OS
Time frame: Participants will be followed for an expected average of 1 year
Overall survival (OS)
-
LFS
Time frame: Participants will be followed for an expected average of 1 year
Leukemia-free survival (LFS) was defined as the survival period with continuous CR.
-
CIR
Time frame: Participants will be followed for an expected average of 1 year
The cumulative incidence of relapse (CIR)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Peking University People's Hospital
Other
Collaborators
- Anhui Provincial Hospital
- First Affiliated Hospital of Fujian Medical University
- First Affiliated Hospital of Guangxi Medical University
- First Affiliated Hospital of Xinjiang Medical University
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Hebei Yanda Ludaopei Hospital
- Jiangsu Provincial People's Hospital
- Nanfang Hospital, Southern Medical University
- Peking University First Hospital
- Ruijin Hospital
- Shandong Provincial Hospital
- Shengjing Hospital
- The First Affiliated Hospital of Soochow University
- The First Affiliated Hospital of Zhengzhou University
- Tongji Hospital
- Xinqiao Hospital of Chongqing
- Zhejiang University
Registry information
Official study title
A Multicenter Prospective Study of Second Haploidentical Transplantation for Graft Failure After the First Haploidentical Transplantation
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Jul 22, 2024
- Registry last updated
- Nov 7, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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