Modified Second Haplo-transplantation for Graft Failure

Peking University People's Hospital12 enrolled

Overview

Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. We previously reported encouraging results with a novel Flu/Cy regimen. However, there are still around 20% patients developed delayed platelet recovery. We designed a modified regimen to further improve the hematopoietic reconstitution after second transplantation. This prospective, single-arm study aims to investigate the safety and efficacy of this modified regimen.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Graft Failure Stem Cell Transplant Complications

Interventions

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)/rabbit antithymocyte globulin (1.5mg/kg/day, days -4 to -2) 3. GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg, +1d, +8d, +15d)

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1.Primary disease: hematological malignancies(AML, CML, MDS, lymphoma, etc.); 2.Graft failure after first allogeneic 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,

Outcomes

Primary Outcomes

Engraftment of neutrophils

Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.

Time frame: 28 days after second transplantation

Secondary Outcomes

Engraftment of Platelet

Platelet engraftment was defined as the first of 7 consecutive days that platelet counts ≥20 × 10\^9/L in the absence of platelet transfusion

Time frame: 100 days after second transplantation

TRM at 28 day

treatment-related mortality(TRM) was defined as death from any cause other than relapse.

Time frame: 28 days after second transplantation

TRM at 100 day

treatment-related mortality (TRM) was defined as death from any cause other than relapse

Time frame: 100 days after second transplantation

GVHD

Both acute and chronic GVHD was diagnosed and graded according to international criteria.

Time frame: Participants will be followed for an expected average of 1 year

Overall survival (OS)

Time frame: Participants will be followed for an expected average of 1 year

LFS

Leukemia-free survival (LFS) was defined as the survival period with continuous CR.

Time frame: Participants will be followed for an expected average of 1 year

CIR

The cumulative incidence of relapse (CIR)

Time frame: Participants will be followed for an expected average of 1 year

Modified Second Haplo-transplantation for Graft Failure

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts