Aplastic Anemia Clinical Trial
Official title:
Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA
The haplotype HSCT system including Bu(0.8mg/kg Q6hx2d)CTX(50mg/kgx4d)rATG(2.5mg/kgx4d) , established in Institute of Hematology of Peking University ,has been evaluated to be effective for acquired SAA.But some patients with high risk factors may not tolerate CTX 200mg/kg,alternative conditioning regimen including Bu/Fludarabine/dercreased CTX was studied in this trial.
Status | Recruiting |
Enrollment | 55 |
Est. completion date | March 30, 2022 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 55 Years |
Eligibility |
A:inclusion criteria 1. Patients diagnosed as acquired severe aplastic anemia(SAA) /very vSAA 2. patients with age 3-55 years 3. patients have no matched sibling donor 4. Patients have no matched unrelated donor 5. patients have no severe infection 6. Patients have no severe organ dysfunction 7. patients have risk factors of potential intolerance to previous condition regimen including BuCy(200mg/kg)and ATG 8. Consent form signed B. Exclusion criteria : 1. patients with congenital SAA/vSAA 2. patients with age< 3years or >55 years 3. patients with matched sibling donor 4. patients with matched URD 5. patients with severe infection 6. patients with severe organ dysfunction 7. pregnancy women 8. no Consent form signed |
Country | Name | City | State |
---|---|---|---|
China | Peking University Institute of Hematology,People's hospital Peking University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1 year cumulative incidence overall survival | Tne cumulative incidence of overall survival at 1 year post HSCT | 1 year post HSCT | |
Secondary | one month Transplantation related mortality | Tne cumulative incidence of transplantation related motality at 1 month post HSCT | 1 month post HSCT | |
Secondary | Engraftment | Tne cumulative incidence of engraftment at 1 moths post HSCT | 1 month post HSCT | |
Secondary | 0ne month regimen-related toxicity | Tne cumulative incidence of regimen related toxicity at 1 month post HSCT | 1 month post HSCT | |
Secondary | aGVHD | Tne cumulative incidence of acute GVHD at Day 100 post HSCT | 100 days post HSCT | |
Secondary | failure-free survival | The cumulative incidence of failure-free survival at 1year post HSCT | 1 year post HSCT |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03025698 -
A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia
|
Phase 2 | |
Completed |
NCT00987480 -
Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine
|
Phase 2 | |
Completed |
NCT00767650 -
Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia
|
N/A | |
Completed |
NCT02833805 -
NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia
|
Phase 2 | |
Not yet recruiting |
NCT02833493 -
Study of MRI Monitoring in Patients With Aplastic Anemia and Low or Int-1 Risk of MDS Complicated With Iron Overload
|
N/A | |
Recruiting |
NCT02028416 -
Comparison of Two Different Doses of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic Anaemia
|
N/A | |
Completed |
NCT00004474 -
Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
|
Phase 3 | |
Recruiting |
NCT05031897 -
Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant
|
Phase 2 | |
Completed |
NCT04439006 -
Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization
|
Phase 1 | |
Not yet recruiting |
NCT05996393 -
CsA+ATG+AVA vs. CsA+AVA for the Treatment of Newly-diagnosed SAA in the Elderly
|
Phase 4 | |
Completed |
NCT02462252 -
Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome
|
Phase 2 | |
Completed |
NCT01272817 -
Nonmyeloablative Allogeneic Transplant
|
N/A | |
Completed |
NCT00513175 -
Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia
|
N/A | |
Completed |
NCT00001398 -
Stem Cell Factor Medication for Aplastic Anemia
|
Phase 1 | |
Recruiting |
NCT01861093 -
Safety Study of Cord Blood Units for Stem Cell Transplants
|
Phase 2 | |
Not yet recruiting |
NCT05018936 -
Efficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia
|
Phase 2/Phase 3 | |
Completed |
NCT00065260 -
Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia
|
Phase 2 | |
Recruiting |
NCT02007811 -
Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination
|
Phase 1/Phase 2 | |
Recruiting |
NCT01758042 -
Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
|
N/A | |
Terminated |
NCT01500161 -
Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match
|
Phase 2 |