A Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Myelofibrosis (MF)

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• Primary Myelofibrosis 419

Primary Myelofibrosis

419 studies on the registry are indexed under Primary Myelofibrosis; 117 are open to participants now.

This study's planned enrollment of 92 is above the median of 44 across 347 interventional studies indexed under Primary Myelofibrosis.

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Study arms

• Experimental
  TQ05105 Tablets + TQB3617 Capsules

  TQ05105 Tablets combined with TQB3617 Capsules, orally administered. 21 days as a treatment cycle. TQB3617 Capsules, orally administered, 21 days as a treatment cycle.

  Drug: TQ05105 Tablets · Drug: TQB3617 Capsules

Interventions

• DrugTQ05105 Tablets

  TQ05105 Tablets is a Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) Inhibitor.

• DrugTQB3617 Capsules

  TQB3617 Capsules is a Bromodomain and Extra-Terminal (BET) Inhibitor

Primary outcomes

1. Maximal tolerance dose (MTD)

   If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.

   Time frame: Up to 2 years.

2. Recommended phase II dose (RP2D)

   The RP2D is defined as the lower dose level to MTD based on the safety profile.

   Time frame: Up to 2 years

3. ≥35% reduction in spleen volume (SVR35)

   The proportion of subjects with a ≥35% reduction in spleen volume from baseline at the end of treatment at week 24.

   Time frame: Up to 24 weeks

Secondary outcomes

1. SVR35

   The proportion of subjects with a ≥35% reduction in spleen volume compared to baseline after treatment.

   Time frame: Up to 120 weeks

2. Optimum effective rate

   The proportion of subjects with at least once spleen volume reduction ≥ 35% from baseline.

   Time frame: Up to 120 weeks

3. Onset time of splenic response

   The time interval from the first administration to the date when the spleen volume was reduced by ≥ 35 % from baseline.

   Time frame: Up to 120 weeks

4. Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)

   The time between the date when the spleen volume reduction ≥ 35% from baseline occurs for the first time and the date when the spleen volume reduction is \< 35% from baseline.

   Time frame: Up to 120 weeks

5. Myeloproliferative neoplasm - Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS)

   The proportion of subjects whose total symptom score of MPN-SAF TSS decreased by more than 50% from baseline. MPN-SAF-TSS is an effective tool for evaluating the disease burden of patients with myeloproliferative neoplasms. Each symptom is scored according to the severity, from asymptomatic (0 points) to the most serious (10 points), a total of 10 levels, the sum of 10 symptom scores is MPN-SAF-TSS score. The higher the score, the more severe the symptoms are.

   Time frame: Up to 60 weeks

6. MPN-SAF TSS change

   The total score of MPN-SAF TSS decreased compared with baseline. MPN-SAF-TSS is an effective tool for evaluating the disease burden of patients with myeloproliferative neoplasms. Each symptom is scored according to the severity, from asymptomatic (0 points) to the most serious (10 points), a total of 10 levels, the sum of 10 symptom scores is MPN-SAF-TSS score. The higher the score, the more severe the symptoms are.

   Time frame: Up to 120 weeks

7. Variant allele frequency (VAF)

   The proportion of subjects whose VAF decreased compared with baseline.

   Time frame: Up to 48 weeks

8. The proportion of subjects with gene mutation achieving SVR35

   The proportion of subjects with gene mutation achieving SVR35

   Time frame: Up to 48 weeks

9. The proportion of subjects with gene mutation whose MPN-SAF TSS scale decreased by ≥ 50%

   The proportion of subjects with gene mutation whose MPN-SAF TSS scale decreased by ≥ 50% compared with baseline.

   Time frame: Up to 48 weeks.

10. Progression-free survival (PFS)

    The time interval from the first dose to the date of the occurrence of any of the following events, whichever occurs first:(1) Spleen volume increased by ≥25% compared with the screening period ; (2) Death caused by any cause.

    Time frame: Up to 120 weeks

11. Leukemia free survival (LFS)

    The time interval from the date of the first dose to the date of any of the following events, whichever occurs first: (1) the date of the first bone marrow smear showing the original cell ≥20% ;(2) The first peripheral blood smear showed that the original cells ≥ 20% and the absolute value of the original cells ≥1×10\^9/L and lasted for at least 2 weeks; (3) Death caused by any reason.

    Time frame: Up to 120 weeks

12. Overall Survival (OS)

    OS is defined as the time from the first time the subject received treatment to death due to any cause.

    Time frame: Up to 120 weeks

13. Incidence of adverse events (AEs)

    Incidence rate of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

    Time frame: Baseline up to 120 weeks

14. Severity of adverse events (AEs)

    Severity of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

    Time frame: Baseline up to 120 weeks