Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03335943
Status:
UNKNOWN
Last Update Posted:
2017-11-08
First Post:
2017-10-17
Brief Title:
Myelodysplastic Syndrome--CDA-2 Hematological Improvement National Affirmation Study
Sponsor:
Chinese Society of Hematology
Organization:
Chinese Society of Hematology
Study Overview
Official Title:
The Efficacy and Safety of CDA-2 for the Treatment of IPSS LowerIntermediate-risk Myelodysplastic Syndrome Patients a Multi-centered Prospective Open Study
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MD-CHINA
Brief Summary:
This Study aims to evaluate the efficacy and safety of CDA-2 in the treatment of International Prognostic Scoring System IPSS LowerIntermediate-risk myelodysplastic syndrome MDS in Chinese patients
Detailed Description:
Patients with lowerintermediate-risk myelodysplastic syndrome MDS have rare therapeutic options other than supportive care In pilot studies CDA-2 showed promising results of hematological improvement in these patients
To date the optimal regimen for CDA-2 treatment is not well established The researchers are going to make a multi-centered clinical trial to evaluate the efficacy and safety of CDA-2 in 800 patients with International Prognostic Scoring SystemIPSS LowerIntermediate-risk myelodysplastic syndrome MDS
Eligible patients will be given CDA-2 intravenously with 200 ml each day for 14 consecutive days in every four weeks one cycle The treatment will be repeated at least for 3 cycles The patients will be followed up to 24 weeks
The primary endpoint is hematological improvement HI at 12 weeks according to IWG criteria Full blood counts will be done on all patients every week Change in bone marrow function as measured by changes in bone marrow morphology and cytogenetics will be assessed before and after 3 cycles of the treatment
The secondary endpoint is the therapy response Complete remission CR partial remission PR and response duration side effects evaluation of QOL will be evaluated at the end of the treatment in every cycle
Adverse events of the treatment will be recorded for evaluation of the safety
To date the optimal regimen for CDA-2 treatment is not well established The researchers are going to make a multi-centered clinical trial to evaluate the efficacy and safety of CDA-2 in 800 patients with International Prognostic Scoring SystemIPSS LowerIntermediate-risk myelodysplastic syndrome MDS
Eligible patients will be given CDA-2 intravenously with 200 ml each day for 14 consecutive days in every four weeks one cycle The treatment will be repeated at least for 3 cycles The patients will be followed up to 24 weeks
The primary endpoint is hematological improvement HI at 12 weeks according to IWG criteria Full blood counts will be done on all patients every week Change in bone marrow function as measured by changes in bone marrow morphology and cytogenetics will be assessed before and after 3 cycles of the treatment
The secondary endpoint is the therapy response Complete remission CR partial remission PR and response duration side effects evaluation of QOL will be evaluated at the end of the treatment in every cycle
Adverse events of the treatment will be recorded for evaluation of the safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None