Graft Failure, Stem Cell Transplant Complications
Conditions
Brief summary
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.
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)
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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,
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.
Outcome results
None listed