Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure
Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05875649
Collaborator
(none)
137
2
55.1
68.5
1.2
Study Details
Study Description
Brief Summary
Most of patients with acute myeloid leukemia achieved complete remission (CR) after primary induction chemotherapy, there were 20-30% patients without CR after first-induction. It was uncertain how to treat these patients. It was investigated in our study that these patients were re-induced with CLAG Regimen. The CR ratio, overall survival (OS) and relapsed-free survival (RFS) was statistically analysed in these patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
137 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Retrospective Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure
Anticipated Study Start Date
:
May 17, 2023
Anticipated Primary Completion Date
:
Jun 20, 2023
Anticipated Study Completion Date
:
Dec 20, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group Acute myeloid leukemia patients with first-induction failure |
Combination Product: CLAG
Acute myeloid leukemia patients are re-induced by CLAG Regimen after first-induction failure
|
Outcome Measures
Primary Outcome Measures
- Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction failure [6 months]
CLAG Regimen improves CR rate in acute myeloid leukemia patients with first-induction failure
Eligibility Criteria
Criteria
Ages Eligible for Study:
14 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Acute myeloid leukemia patients with first-induction failure
Exclusion Criteria:
- Acute myeloid leukemia patients with serious infection and organ dysfunction.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanfang Hospital of Southern Medical University | Guanzhou | Guangdong | China | 510515 |
| 2 | Nanfang Hospital of Southern Medical University | Guanzhou | Guangdong | China | 510515 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
Investigators
- Study Chair: Xuejie Jiang, Doctor, Nanfang Hospital of Southern Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT05875649
Other Study ID Numbers:
- NEFC-2023-162
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nanfang Hospital of Southern Medical University
Additional relevant MeSH terms: