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Tests treatment safety and results for Relapsed/Refractory Acute Myeloid Leukemia (R/R-AML)
Official title Phase IIa Study to Assess Safety and Efficacy in the Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06532058
What this study is testing
What is QHRD107 capsule，Venclexta and Azacitidine?
QHRD107 capsule，Venclexta and Azacitidine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for relapsed/refractory acute myeloid leukemia (r/r-aml).
Also referred to as CDK9 inhibitors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Understand and voluntarily sign informed consent;
- Age 18 and above;
- people with confirmed International Consensus Classification (ICC) relapsed/refractory acute myeloid leukemia (R/R-AML) : Recurrence was defined as...
- Initial treatment cases that failed after 2 courses of treatment with standard protocols;
- Relapse within 12 months after complete remission (CR) after consolidation and intensive treatment;
You likely can't join if
- people previously treated with other CDK9 inhibitors;
- people who are allergic to the active ingredients and/or excipients of the investigational drugs (QHRD107, Veneckla, and azacytidine);
- people with a history of myeloproliferative tumors (MPN);
- people with a history of chronic myeloid leukemia (CML);
- people with Ph chromosome-positive or BCR-ABL fusion gene positive acute myeloid leukemia (AML);
- Confirmed acute promyelocytic leukemia;
See the full eligibility criteria
- Understand and voluntarily sign informed consent;
- Age 18 and above;
- people 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...
- Initial treatment cases that failed after 2 courses of treatment with standard protocols;
- 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);
- people 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;
- people 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...
- 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...
- Ability to understand and conduct visits, treatments, laboratory tests, and other research procedures as planned;
- Male/female people 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 people with...
- people previously treated with other CDK9 inhibitors;
- people who are allergic to the active ingredients and/or excipients of the investigational drugs (QHRD107, Veneckla, and azacytidine);
- people with a history of myeloproliferative tumors (MPN);
- people with a history of chronic myeloid leukemia (CML);
- people with Ph chromosome-positive or BCR-ABL fusion gene positive acute myeloid leukemia (AML);
- Confirmed acute promyelocytic leukemia;
- Patients with AML central nervous system infiltration;
- people 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 people; people with active HBV infection: hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, and peripheral blood hepatitis B virus...
- 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...
- 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 people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changzhou, Jiangsu, China
- Huaian, Jiangsu, China
- Nanjing, Jiangsu, China
- Shenyang, Liaoning, China
- Jinan, Shangdong, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Wuhan, Hubei, China; Changzhou, Jiangsu, China; Huaian, Jiangsu, China; Nanjing, Jiangsu, China; Shenyang, Liaoning, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.