Anti-thymocyte globulin, cyclosporine A and Low-dose danazoL for Idiopathic Untreated Moderate to severe aplastic anemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004219

Enrollment

Registered

2019-08-20

Start date

2019-09-25

Completion date

Unknown

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Anti-thumocyte globulin An intravascular injection of 25 mg of test capacity must be performed before ATG administration. Subjects with systemic reactions (doughness, rapid cardiac arrest, shor

s first dose. Adjust the capacity so t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Subtitleplastic anemia: Patients with less than 25% fidelity in the bone marrow test (1) Age: 19 years or older (2) Severe Acute: Patients with secondary, severe, or primary or secondary dysplasia (3) Those who have read, understood and signed the consent form passed by the Ethics Committee of each agency.

Exclusion criteria

Exclusion criteria: (1) Congenital AA diagnosis (e.g., Fanconi anemia, congenital albinism). (2) Chromosome aberrations other than trigomy 8. (It is not necessary to delay the start of treatment until the results of the cell genetics study are available.) (3) Conducting the Eastern Cooperative Oncology Group (ECOG) Status score ? 2. (4) Subject who has been treated with IST and ATG and/or CSA in the past; (5) Hypersensitivity to rabbit-originated products and CSA (6) Pregnant or breastfeeding. (7) Continuous administration of immunosuppressive drugs other than steroids. (8) Left atrium exudation rate at rest < 50%. (9) O2 saturation < 90%. (10) Blood serum creatinine > 1.3 mg/dl. (11) Past maladies. (12) Active infection. (13) Unadjusted Diabetes (14) Subject to taboo by administration of cyclosporin, methylfrednisolone or Danazole agents; (15) Subject with blood-linked hematopoietic transplantation donor and possible hematopoietic transplantation

Design outcomes

Primary

Measure	Time frame
Complete Response-- Hemoglobin>= 11g/dl,Neutrophil>=1.5 x 109/L, platelet = 100x109/L, no more than 2 weeks of transfusion;Partial Response-- Hemoglobin>= 8g/dl,Neutrophil>=0.5 x 109/L, platelet = 20x109/L;Non-response- Blood levels are not changed or blood levels are deteriorated without a reduction in blood transfusion requirements;Re-occurrence- Blood cell returns to levels that meet SAA or MAA criteria// transfusion-requires transfusion from those who have achieved non-dependent state;EBV-Reactivated Target Percentage and EBV-Related People Rate with Related Lymphogenic Diseases	—

Measure

Time frame

Complete Response-- Hemoglobin>= 11g/dl,Neutrophil>=1.5 x 10*9/L, platelet = 100x10*9/L, no more than 2 weeks of transfusion;Partial Response-- Hemoglobin>= 8g/dl,Neutrophil>=0.5 x 10*9/L, platelet = 20x10*9/L;Non-response- Blood levels are not changed or blood levels are deteriorated without a reduction in blood transfusion requirements;Re-occurrence- Blood cell returns to levels that meet SAA or MAA criteria// transfusion-requires transfusion from those who have achieved non-dependent state;EBV-Reactivated Target Percentage and EBV-Related People Rate with Related Lymphogenic Diseases

—

Secondary

Measure	Time frame
IWG 2018 MDS hematological improvement proposal38- hematological improvement;CMV-Target with Reactivation	—

Countries

Korea, Republic of

Contacts

Public ContactJonghee Han

Gachon University Gil Medical Center

Outcome results