Second Haplo-transplantation for Graft Failure

A Multicenter Prospective Study of Second Haploidentical Transplantation for Graft Failure After the First Haploidentical Transplantation

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06512519

Enrollment

Registered

2024-07-22

Start date

2024-07-01

Completion date

2027-06-30

Last updated

2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Failure, Stem Cell Transplant Complications

Brief summary

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.

Interventions

OTHERsecond allogeneic stem cell transplantation

1. Change another donor if possible 2. Conditioning regimen: fludarabine (30mg/m2/day, days -6 to -2 ), cyclophosphamide (1g/m2/day, days -5 to -4) 3. GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg -1d, +4d, +15d)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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,

Design outcomes

Primary

Measure	Time frame	Description
Engraftment of neutrophils	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

Measure	Time frame	Description
TRM at 28 day	28 days after second transplantation	treatment-related mortality (TRM) was defined as death from any cause other than relapse
TRM at 100 day	100 days after second transplantation	treatment-related mortality (TRM) was defined as death from any cause other than relapse
GVHD	Participants will be followed for an expected average of 1 year	Both acute and chronic GVHD was diagnosed and graded according to international criteria.
Engraftment of Platelet	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
LFS	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	Participants will be followed for an expected average of 1 year	The cumulative incidence of relapse (CIR)
OS	Participants will be followed for an expected average of 1 year	Overall survival (OS)

Countries

China

Contacts

Primary ContactYu-qian Sun, M.D.

sunyuqian83@hotmail.com+86-10-88324577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026