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Relapsed/Refractory Acute Myeloid Leukemia (R/R-AML)Phase 2NCT06532058

Phase IIa Study to Assess Safety and Efficacy in the Relapsed/Refractory Acute Myeloid Leukemia

A Phase 2 study testing QHRD107 capsule，Venclexta and Azacitidine in people with Relapsed/Refractory Acute Myeloid Leukemia (R/R-AML), run by Changzhou Qianhong Bio-pharma Co., Ltd. at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the safety and efficacy of QHRD107 capsule combined with Venclexta and azacitidine in the treatment of relapsed/refractory acute myeloid leukemia: a single-arm, open, multicenter Phase IIa study Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
QHRD107 capsule，Venclexta and Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
10 sitesChina
Study dates
10 Aug 2023to 10 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand and voluntarily sign informed consent;
  • Age 18 and above;
  • Subjects with confirmed International Consensus Classification (ICC) relapsed/refractory acute myeloid leukemia (R/R-AML) :
  • Recurrence was defined as the recurrence of leukemia cells in peripheral blood or ≥5% of bone marrow original cells after complete response (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or the occurrence of extramedullary leukemia cell infiltration.
  • Refractory is defined as meeting any of the following criteria:
  • Initial treatment cases that failed after 2 courses of treatment with standard protocols;
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  • Relapse within 12 months after complete remission (CR) after consolidation and intensive treatment;
  • Recurrence after 12 months but failed to respond to conventional chemotherapy;
  • Two or more relapses.
  • ECOG evaluation ≤2 points;
  • Expected survival ≥3 months;
  • White blood cell (WBC) count <25×109 cells /L (hydroxyurea is allowed to control the white blood cell count before treatment);
  • Subjects must have adequate liver function: total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN;
  • Subjects must have adequate renal function: creatinine clearance ≥50 mL/min (calculated using the Cockroft-Gault formula);
  • The subject has recovered from previous therapeutic toxicity to < grade 2 (according to CTCAE 5.0 criteria), excluding primary disease effects. The following are excluded: hair loss, fatigue, hyperpigmentation, stable hypothyroidism with hormone replacement therapy, peripheral nerve toxicity after chemotherapy;
  • Eluting period from the first administration of antitumor therapy: a) At least 2 weeks between the end of cytotoxic chemotherapy drug treatment; b) Non-cytotoxic drugs should be separated by at least 5 half-lives (if the duration of 5 half-lives exceeds 4 weeks, the washout period is still measured by 4 weeks), and the interval > 4 weeks shall prevail if the half-life is not clear; c) Anti-tumor Chinese medicine at least 2 weeks interval;
  • Ability to understand and conduct visits, treatments, laboratory tests, and other research procedures as planned;
  • Male/female subjects with reproductive potential must use effective contraception from the date of signing the informed consent until 6 months after the last trial medication. At the same time, male subjects with reproductive potential must refrain from sperm donation from signing their informed consent until six months after the last trial medication.

Who cannot join

  • Subjects previously treated with other CDK9 inhibitors;
  • Subjects who are allergic to the active ingredients and/or excipients of the investigational drugs (QHRD107, Veneckla, and azacytidine);
  • Subjects with a history of myeloproliferative tumors (MPN);
  • Subjects with a history of chronic myeloid leukemia (CML);
  • Subjects with Ph chromosome-positive or BCR-ABL fusion gene positive acute myeloid leukemia (AML);
  • Confirmed acute promyelocytic leukemia;
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  • Patients with AML central nervous system infiltration;
  • Subjects with extramedullary leukemia (such as myeloid sarcoma, skin infiltration, etc.) (except extramedullary lesions such as liver, spleen, and lymph node involvement);
  • Human immunodeficiency virus (HIV) antibody positive subjects; Subjects with active HBV infection: hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, and peripheral blood hepatitis B virus (HBV-DNA) higher than the upper limit of normal; Subjects with active HCV infection: HCV antibody positive, peripheral blood HCV RNA positive;
  • The subject has an active infection (including bacterial, viral, and fungal infections) that requires systemic antibiotic treatment as determined by the investigator to be clinically significant;
  • People with significant active cardiovascular disease within the previous 6 months, including but not limited to: ≥III Heart failure as defined by the New York Heart Association (NYHA); Angina pectoris requiring surgical treatment, unstable angina pectoris, myocardial infarction; Hypertension that remains poorly controlled after treatment (i.e., systolic ≥160 mmHg, diastolic ≥90 mmHg); Uncontrolled arrhythmias; The left ventricular function resting ejection fraction measured by echocardiography was less than 50%. QT interval: > 450 ms for men and > 470 ms for women (according to the QTcF formula), or are on medication known to lengthen the QT/QTc interval, or have other factors that may lengthen the QTc interval; Or for patients whose QT interval is still > 450 ms after QT interval prolongation treatment;
  • Patients who have received allogeneic hematopoietic stem cell transplantation within 60 days of their initial investigational treatment must discontinue all immunosuppressants during the investigational treatment;
  • Patients who have previously received CAR-T therapy;
  • The subject has a malabsorption syndrome or other comorbid condition that prevents him from swallowing the capsule or administering the drug through enteral channels;
  • A history of other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast;
  • Pregnant or lactating women, or subjects who are fertile and do not want to take effective contraceptive measures;
  • Any ill-controlled clinical problems (such as severe psychiatric, neurological, cardiovascular, respiratory, digestive, urinary, etc.) or other factors that the investigator believes prevented the subject from completing the study.

Trial locations and contacts

10 sites in 1 country.

Li Junmin, Doctor contact

13817712211

lijunmin@medmail.com.cn

10 sites in 1 country

China10 sites, 10 recruiting

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213000

    Li Jie, doctor, 0519-68870885, czyygcp@czfph.com

    Gu Weiying, doctor

    Recruiting

  • Huai 'an First People's Hospital

    Huaian, Jiangsu, 223300

    Liu Yanfei, Doctor, 0517-80872519, hayyyw@qq.com

    Wang Chunling, Doctor

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shangdong, 250000

    Zhao shiliang, doctor, 0531-82165412, zhaoshiliang208@163.com

    Ji Min, doctor

    Recruiting

  • Zhongda Hospital

    Nanjing, Jiangsu, 210009

    Yang Yue, bachelor, 025-83272084, whp57@163.com

    Ge Zheng, Doctor

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210036

    Chai Yi, doctor, 025-68306259, littlechaiyi@163.com

    Qian Sixuan, Doctor

    Recruiting

  • Tongren Hospital Shanghai Jiao Tong University School Of Medicine

    Shanghai, Shanghai Municipality, 200000

    Gan Yuan, bachelor, 021-52039999021-52039999-6310, gcpjgb@163.com

    Liu Ligen, doctor

    Recruiting

  • Ruijin hospitol

    Shanghai, Shanghai Municipality, 200025

    WU Jiajie, bachelor, 021-64370045 ext. 675205, ruijin_gcp@126.com

    Recruiting

  • ShengJing Hospital

    Shenyang, Liaoning, 110004

    Li Hui, doctor, 024-96615-71146, lih@sj-hospital.org

    Yang Wei, doctor

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430000

    Chen Bo, doctor, 027-67813097, znyysysm@126.com

    Zhou Fuling, doctor

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Wu Jilian, doctor, 400-0371-818, jleewu@163.com

    Zhang Yanli, Doctor

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of QHRD107 Capsule Combined With Venclexta and Azacitidine in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia: a Single-arm, Open, Multicenter Phase IIa Study

The purpose of this study is to assess the safety and efficacy of QHRD107 capsule combined with Venclexta and azacitidine in the treatment of relapsed/refractory acute myeloid leukemia: a single-arm, open, multicenter Phase IIa study

Read the detailed description

This study is a single-arm, open, multicenter phase IIa clinical study, which is divided into two stages: the dose-increasing study phase and the dose-expanding exploration phase. The purpose of the dose-escalation phase is to explore the safety and tolerability of QHRD107 capsule（40mgBID,60mgBID and 80mgBID） combined with Venclexta and azacitidine, to evaluate the efficacy of the three-drug combination in subjects with relapsed/refractory acute myeloid leukemia (R/R-AML), and to explore the pharmacokinetic characteristics of the combination. The dose expansion stage aims to further evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of QHRD107 capsule（60mgBID and 80mgBID）combined with Venclexta and azacitidine on the basis of exploring the safe dose range determined in the dose escalation stage, and determine the recommended dose for subsequent clinical studies

Being tested
QHRD107 capsule，Venclexta and Azacitidine
Medical subject headings
Recurrence, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QHRD107 capsule，Venclexta and AzacitidineDrug

    Also called CDK9 inhibitors

    QHRD107（orally），Venclexta（orally），Azacitidine（subcutaneous injection）

Study groups in NCT06532058
Study groupRoleWhat they receive
Part-A (Cohort 1-3)ExperimentalThree dose groups were set up. The doses of QHRD107 capsules were 40 mg Q12H, 60 mg Q12H and 80 mg Q12H, respectively, combined with Venclexta and Azacitidine.
Receives: Drug: QHRD107 capsule，Venclexta and Azacitidine
Part-B (Cohort 1-2)ExperimentalCohort 1： [QHRD107 capsule 60mg Q12H D1-28]+[Venclexta QD D1-28]+[Azacitidine QD D1-7]; Cohort 1：[QHRD107 capsule 80mg Q12H D1-28]+[Venclexta QD D1-28]+[Azacitidine QD D1-7] .
Receives: Drug: QHRD107 capsule，Venclexta and Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose（Dose Escalation Phase）

    Enrolled subjects performed dose climbing according to the "3+3 principle".The highest dose of DLT（Dose-Limiting Toxicity） incidence 1/6 is MTD

    Measured: From screenng through to 28 day follow up period

  2. The Compound complete response rate (CCR) and the corresponding mitigation duration (DORccr)（Dose expansion phase）

    The Compound complete response rate (CCR) was defined as the percentage of participants who achieved complete remission(CR),CR with partial hematologic recovery(CRh),CR with incomplete hematologic recovery (CRi) per the European LeukemiaNet (ELN) recommendations for AML. CR was defined as bone marrow blasts < 5%, absence of circulating blasts,absence of extramedullary disease,ANC ≥ 1.0 × 10˄9/L (1,000/µL),platelet count ≥ 100 × 10˄9/L (100 000/µL).CRh was defined as ANC ≥ 0.5 × 10˄9/L (500/µL) and platelet count ≥ 50 × 10˄9/L (50000/µL), otherwise all other CR criteria met.CRi was defined as all CR criteria except for residual neutropenia < 1.0 × 10˄9/L (1,000/µL) or thrombocytopenia < 100 × 10˄9/L (100 000/µL).DORccr refers to the time between the first assessment of efficacy reaching CR/CRi/CRh/MLFS/PR and the first assessment of disease recurrence or death from any cause.

    Measured: From the date of the patient first received treatment to the end of the fourth cycle（each cycle is 28 days）

Secondary outcomes (9)

  1. Safety as assessed by incidence ,severity,and causality of adverse events

    The frequency and number of Adverse events

    Measured: From the date of the patient first received treatment to the end of the fourth cycle（each cycle is 28 days）

  2. Plasma measurements of QHRD107

    The concentration of QHRD107 was measured at 3 different doses

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  3. Complete Remission Rate

    The complete remission (CR) rate was defined as the percentage of participants who achieved CR per the ELN criteria for AML.

    Measured: From the date of the patient first received treatment to the end of the fourth cycle（each cycle is 28 days）

  4. Objective Remission Rate

    The objective remission rate (ORR) was defined as the percentage of participants who achieved CR, CRh, CRi,morphologic leukemia-free state (MLFS),or partial remission (PR) per the ELN for AML.Partial remission (PR) was defined as normalization in peripheral blood neutrophil and platelet counts with at least a 50% decrease in blasts persisting in bone marrow versus baseline.MLFS was defined as bone marrow blasts < 5%,absence of circulating blasts, absence of extramedullary disease, no hematologic recovery required.

    Measured: From the date of the patient first received treatment to the end of the fourth cycle（each cycle is 28 days）

  5. Duration of Remission(DOR)

    Duration of remission was defined as the number of days from the date of first remission (CR, CRi, or PR) per the IELN criteria for AML to the earliest recurrence or progressive disease (PD).

    Measured: From the date of the patient first received treatment to the end of the fourth cycle（each cycle is 28 days）

  6. Time to first CR, CRi, CRh,MLFS,and PR

    Time to first CR, CRi, CRh,MLFS,and PR was defined as the time from the start of the first dose until the first observation of CR or CRh or CRi or MLFS or PR

    Measured: From the date of the patient first received treatment to the end of the fourth cycle（each cycle is 28 days）

  7. Rate of Minimal Residual Disease (MRD) Negativity

    The rate of minimal residual disease (MRD) response was defined as the percentage of participants who had MRD negative status.

    Measured: From the date of the patient first received treatment to the end of the fourth cycle（each cycle is 28 days）

  8. Event-free lifetime

    For all subjects, the time from first dosing to treatment failure, or disease recurrence, or death from any cause, whichever occurred first. Treatment ineffectiveness was defined as failure to achieve CR, CRh, CRi, or MLFS after ≤4 cycles of treatment.

    Measured: From the date of the patient first received treatment to the end of the fourth cycle（each cycle is 28 days）

  9. Overall survival

    Overall survival(OS) was defined as the time from the date of first treatment to the date of death

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start10 Aug 2023
  3. Primary completion10 Feb 2025 (estimated)
  4. Study completion10 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
a single-arm, open, multicenter Phase IIa study with dose escalation and dose extension
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06532058
Sponsor's protocol ID
QH-RD107-02-01
Status last verified
Jul 2024
First submitted
20 Jul 2024
Last updated
1 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QHRD107 capsule，Venclexta and Azacitidine in people with Relapsed/Refractory Acute Myeloid Leukemia (R/R-AML), run by Changzhou Qianhong Bio-pharma Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Junmin, Doctor (13817712211, lijunmin@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose（Dose Escalation Phase） (time frame: From screenng through to 28 day follow up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06532058.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.

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