Health TrialsbyHealthPanel

CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML

ConditionAcute Myeloid Leukemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNavy General Hospital, Beijing

About this trial

The goal of this phase 2 trial is to test the safety and efficacy of CHG Combined With Venetoclax in treating patients with newly diagnosed AML.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.

The patient is willing and able to adhere to the study visit schedule and other protocol requirements.

The patient should be diagnosed with AML according to the standard criteria of the World Health Organisation (WHO).

The patient should not have received any prior treatment for AML.

Disqualifiers

Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.

Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.

Pregnant or lactating women.

Trial design

Design model

Single group

Treatments tested in this trial

  • CHG Combined With Venetoclax and Azacytidine

    Drug

    Patients were treated by CHG Combined With Venetoclax and Azacytidine: Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-14; Azacytidine 75 mg/m2 subcutaneous injection qd d1-7; Homoharringtonine 1mg/m2 iv qd d1-14; Cytarabine 10mg/m2 subcutaneous injection q12h d1-14; G 250ug/m2 subcutaneous injection qd d0-14.

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: CHG Combined With Venetoclax and AzacytidineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

ORR was defined as the proportion of patients who achieved CR or PR as their best response

Time frame
1 year

Secondary outcomes

1

Overall Survival (OS)

OS was defined as time from diagnosis to death from any cause or the last follow-up

Time frame
through study completion, an average of 3 years
2

Progression Free Survival (PFS)

For patients in morphologic remission, documented relapse was considered progression. Relapse following complete remission(CR) is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Navy General Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: