NCT03335943

Brief Summary

This Study aims to evaluate the efficacy and safety of CDA-2 in the treatment of International Prognostic Scoring System (IPSS) Lower/Intermediate-risk myelodysplastic syndrome (MDS) in Chinese patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2017

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

October 17, 2017

Last Update Submit

November 4, 2017

Conditions

Myelodysplastic Syndrome (MDS)

Keywords

CDA-2, MDS

Outcome Measures

Primary Outcomes (1)

  • Hematological Improvement (HI) at 12 Weeks

    Hematologic improvement (HI) per International Working Group (IWG),HI: hemoglobin increase of \>= 1.5 g/dL, platelet increase of \>= 30,000/mL (starting with \> 20,000/mL), neutrophils increase of \>= 100% and \> 500/μL.

    12 weeks

Secondary Outcomes (3)

  • Response Rate of The Therapy at 12 Weeks

    12 weeks

  • Red Blood Cell Transfusion Independence (RBC-TI) in 24 weeks

    24 weeks

  • Change From Baseline to that of the 24 weeks of Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ C-30) Physical Functioning Scale

    24 weeks

Study Arms (1)

CDA-2 (Cell Differentiation Agent 2)

EXPERIMENTAL

Patients will be given CDA-2 therapy.

Drug: CDA-2 (Cell Differentiation Agent 2)

Interventions

CDA-2 (Cell Differentiation Agent 2)DRUG

CDA-2 will be given 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.

Also known as: Uroacitides (a compound mixed of peptides and organic acids)
CDA-2 (Cell Differentiation Agent 2)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of MDS according to World Health Organization (WHO)/French American British (FAB) classification that meets IPSS-R classification of low, or intermediate-1 risk disease.
  • Subject is 18 to 85years of age the time of signing the informed consent form (ICF).
  • Able to adhere to the study visit schedule and other protocol requirements
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
  • Laboratory test results within these ranges: Serum creatinine \</=1.5 mg/dL x Upper limit of the normal (ULN),Blood urine nitrogen (BUN)\</=1.5 mg/dL x Upper limit of the normal (ULN),Total bilirubin \</=1.5 mg/dL x Upper limit of the normal (ULN),Serum glutamic oxaloacetic transaminase/aspartate transaminase (SGOT/AST) and Serum glutamic pyruvic transaminase/alanine transaminase (SGPT/ALT)\</=2 x Upper limit of the normal (ULN).
  • No prior intensive combination chemotherapy or dose Azacitidine,Decitabine,and Lenalidomide,etc.
  • Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.

You may not qualify if:

  • IPSS risk group intermediate-2 or high risk
  • breast feeding and pregnant women
  • MDS associated with del 5q cytogenetic abnormality
  • Patients with history of hepatitis B, C, HIV(+), alcoholic liver disease or evidence of hepatopathy will be excluded.
  • Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ma X. Epidemiology of myelodysplastic syndromes. Am J Med. 2012 Jul;125(7 Suppl):S2-5. doi: 10.1016/j.amjmed.2012.04.014.

    PMID: 22735748BACKGROUND

  • Fenaux P, Haase D, Sanz GF, Santini V, Buske C; ESMO Guidelines Working Group. Myelodysplastic syndromes: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii57-69. doi: 10.1093/annonc/mdu180. Epub 2014 Jul 25. No abstract available.

    PMID: 25185242BACKGROUND

Related Links

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 17, 2017

First Posted

November 8, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

November 8, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share