Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04424147
  4. Details
NCT04424147 Clinical Trial

Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML

Refractory Acute Myeloid Leukemia Clinical Trial

Official title:
Efficacy and Safety of HVA Regimens as Salvage Treatment in Relapsed/Refractory (rr) Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04424147
Other study ID # HVA in rrAML
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 27, 2020
Est. completion date June 30, 2022

Study information
Verified date October 2022
Source Nanfang Hospital of Southern Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Up Until now, there is not well acepted treatment for relapsed/refractory (rr) acute myeloid luekemia (AML), which has low complete response and poor survival. According to different guildlines, clinical trial is the first choice for the treatment of rrAML. High expression of BCL-2 and hypermethylation are very important factors for drug resistance in AML. Lots of studies have reported combination of BCL-2 inhibitor with hypomethylating agents (HMA) showed a promising efficacy in elder or unfit patients with newly diagnosed AML, however, presented not that exciting curing effect in rrAML. It is known that overexpression of MCL-1 and BCL-XL is the main reason for leukemia cells being resistant to BCL2 inhibitors. Since Homoharringtonine (HHT) could downregulate MCL-1 and BCL-XL in leukemia cells, there might be a synergic effect for combination of BCL-2 inhibitors with HHT, which has been proven in the treatment of lymphoma. Yet, there is not a report for the use of this combination in AML. In this single arm multi-centers prospective study, adult patients with rrAML are included and treated with BCL-2 inhibitor venetoclax at a dose of 400mg per day for 14 days, combined with azacitidine (AZA) at a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days, and then the eficacy and safety of HVA regimens as salvage treatment in rrAML are assessed.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date June 30, 2022
Est. primary completion date June 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Patients with rrAML Patients with the age of 18-65 years old Exclusion Criteria: - Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) - Patients with any conditions not suitable for the trial (investigators' decision)

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• HVA Regimens as Salvage Treatment
venetoclax with a dose of 400mg per day for 14 days, combined with azacitidine (AZA) with a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days

Locations
Country Name City State
China Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (10)
Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University Maoming People's Hospital, Peking University Shenzhen Hospital, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shenzhen Hospital, Southern Medical University, Shenzhen Second People's Hospital, Sun Yat-sen Memorial Hospital,Sun Yat-sen University, The First People's Hospital of Chenzhou, The Seventh Affiliated Hospital of Sun Yat-sen University, Zhongshan City People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete response Blast rate lower than 5% with or without peripheral blood cell recover At the end of Cycle 2 (each cycle is 28 days)
Secondary Safety and Tolerability of HVA treatment The number of participants experiencing 3/4 degree bone marrow suppession and infection. At the end of Cycle 2 (each cycle is 28 days)
Secondary Disease-free survival one year
Secondary Overall survival one year
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02890329 - Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia Phase 1
Active, not recruiting NCT04975919 - Venetoclax in Combination With Decitabine and Cedazuridine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Phase 2
Terminated NCT02882321 - Oxidative Phosphorylation Inhibitor IACS-010759 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 1
Recruiting NCT03214562 - Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Active, not recruiting NCT03289910 - Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia Phase 2
Completed NCT02756572 - Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms Phase 2
Completed NCT02509546 - 8-Chloroadenosine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Recruiting NCT03683433 - Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation Phase 2
Completed NCT02551718 - High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia N/A
Completed NCT02070458 - Ixazomib, Mitoxantrone Hydrochloride, Etoposide, and Intermediate-Dose Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia Phase 1
Terminated NCT03557970 - JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia Phase 2
Recruiting NCT03661307 - Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome Phase 1/Phase 2
Recruiting NCT03629171 - Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia Phase 2
Recruiting NCT05396859 - Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia Phase 1
Terminated NCT03067571 - Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Phase 2
Completed NCT04146038 - Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease Phase 2
Suspended NCT03128034 - 211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia Phase 1/Phase 2
Active, not recruiting NCT04207190 - Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia Phase 1
Recruiting NCT04047641 - Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Phase 1/Phase 2
Withdrawn NCT04493099 - Alvocidib in Combination With Decitabine and Venetoclax in Patients With Relapsed or Refractory AML or as Frontline Therapy in Unfit Patients With AML Phase 1/Phase 2