Clinical Trials Logo
  1. Home
  2. Acute Myeloid Leukemia
  3. NCT04485052
  4. Details
NCT04485052 Clinical Trial

Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:
A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04485052
Other study ID # CIBI188B201
Secondary ID
Status Suspended
Phase Phase 1/Phase 2
First received
Last updated
Start date September 25, 2020
Est. completion date December 31, 2024

Study information
Verified date October 2023
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia

Recruitment information / eligibility
Status Suspended
Enrollment 222
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML). 2. Relapsed// refractory AML( =18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( =60 ys). 3. Age =18 years old, gender not limited. 4. ECOG score of 0-2. 5. Adequate organ function. Exclusion Criteria: 1. Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase). 2. A history of myeloproliferative diseases (including myelofibrosis, primary thrombocytosis, and true red) Cytosis, chronic myelocytic leukemia) or acute myeloid white blood with BCR-ABL1 translocation Patients. 3. Major surgery and vaccine treatment within 4 weeks. 4. Uncontrolled concurrent diseases. 5. Pregnant or breastfeeding female subjects.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IBI188
anti-CD47 Monoclonal antibody
• Azacitidine
Demethylation drugs
• Decitabine
Demethylation drugs

Locations
Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite complete rate Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery 24 weeks
Secondary Cytogenetic CR 24 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Recruiting NCT04460235 - Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma Phase 4
Completed NCT03678493 - A Study of FMT in Patients With AML Allo HSCT in Recipients Phase 2
Completed NCT04022785 - PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Phase 1
Recruiting NCT05424562 - A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
Terminated NCT03224819 - Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML) Early Phase 1
Completed NCT03197714 - Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Active, not recruiting NCT04070768 - Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113 Phase 1
Active, not recruiting NCT04107727 - Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML) Phase 2
Recruiting NCT04920500 - Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients N/A
Recruiting NCT04385290 - Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC) Phase 1/Phase 2
Recruiting NCT03897127 - Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics Phase 3
Active, not recruiting NCT04021368 - RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Phase 1
Recruiting NCT03665480 - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML Phase 2/Phase 3
Completed NCT02485535 - Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant Phase 1
Enrolling by invitation NCT04093570 - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers Phase 2
Recruiting NCT04069208 - IA14 Induction in Young Acute Myeloid Leukemia Phase 2
Recruiting NCT05744739 - Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML) Phase 1
Recruiting NCT04969601 - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings Phase 1/Phase 2