Aplastic Anemia Clinical Trial
Official title:
Observational Study of MRI Monitoring in Patients With Aplastic Anemia (AA) and Low or Int-1 Risk of Myelodysplastic Syndromes(MDS) Complicated With Iron Overload
Verified date | July 2016 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Observational |
The investigators aim to give an overview of Iron overload(IOL) of patients with AA and low and int-1 risk MDS and their sequelae under different chelation treatment. And the investigators also aim to evaluate the relationship of LIC and T2*/R2*.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | October 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Male or female of 18-80 year old. 2. With blood transfusion history or RBC-transfusion-dependence. 3. BM smear and biopsy plus chromosome analysis within 3 months before signing ICF, otherwise done during screening. 4. Excluding other diseases which might cause hematological abnormalities. 5. Serum ferritin level=500ng/ml with no sign of active infection or malignant disease. 6. Treatment with underlying disease is permitted for non-hematological and hematological conditions. 7. Previous iron chelation therapy like deferasirox or deferoxamine is permitted. 8. ECOG performance score =2 9. All subjects must: agree not to donate blood or be counseled about pregnancy precautions and risks of fetal exposure. 10. Written informed consent. Exclusion Criteria: 1. Patients who are under 18-year-old or over 80-year-old. 2. Prior history of other cancer unless cancer-free for =5 years. Subjects with the following history/concurrent conditions may enroll at any time: Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Prostate cancer stage-1 3. Proved HIV-1 infection 4. Active HBV or active HCV infection. 5. Pregnant or lactating 6. Patients unwilling to or unable to comply with the protocol. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Novartis |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI T2*/R2* for liver and heart | 3 years | Yes |
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 | |
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 | |
Recruiting |
NCT00881933 -
Study of Fludarabine + Cyclophosphamide + TBI Conditioning Regimen for Double Units Cord Blood Transplantation(CBT)in Severe Aplastic Anemia(SAA)
|
Phase 1/Phase 2 |