Myelodysplastic Syndromes
Conditions
Interventions
case series:Realgar-Indigo naturalis Formula(RIF) combined with All-Trans-Retinoic Acid(ATRA)
Sponsors
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Must have a diagnosis of MDS fitting Refractory Anemia With Excess Blasts(RAEB) of the recognized WHO(2008) classifications as determined by CBC, bone marrow assessment, and cytogenetics within 30 days of receiving study drug; 2. Male or female, 60 years of age or older; 3. QT interval of ECG <460ms; 4. Has an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2; 5. Adequate hepatic and renal function as measured by the following pretreatment laboratory criteria: Aspartate transaminase (AST) <2X the upper limit of normal (ULN); Alanine transaminase (ALT): <2 X the ULN; Total bilirubin <1.5 X the ULN; Serum Creatinine <1.5 X the ULN; 6. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Has received an investigational drug within 30 days preceding the first dose of study drug; 2. A history of tumor and accept any the treatment for the tumor in the past three years; 3. Has active viral or bacterial infection, and has uncontrolled infection by using appropriate anti-infection; 4. Has known positive serology for HIV; 5. Has uncontrolled heart trouble; 6. Has a mental illness or any other condition that could prevent full cooperation with the treatment and monitoring requirements of the study; 7. Has inaspirable bone marrow; 8. Has known hypersensitivity to any of the excipients of Realgar-Indigo naturalis Formula(RIF) and All-Trans-Retinoic Acid(ATRA); 9. Has previously been treated with Realgar-Indigo naturalis Formula(RIF) or All-Trans-Retinoic Acid(ATRA), or received hematopoietic stem cell transplantation in the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Marrow response;cytogenetic response rates;transfusion requirements; | — |
Countries
China
Contacts
Public ContactZhijian Xiao
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed