Modified Second Haplo-transplantation for Graft Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
second allogeneic stem cell transplantation
Other intervention1. 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)
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 transplantationSecondary outcomes
1
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 transplantation2
TRM at 28 day
treatment-related mortality(TRM) was defined as death from any cause other than relapse.
Time frame
28 days after second transplantation3
TRM at 100 day
treatment-related mortality (TRM) was defined as death from any cause other than relapse
Time frame
100 days after second transplantation4
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 yearSponsors and contacts
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Source ClinicalTrials.gov