A Clinical Study of MK-4208/TERN-701 in Participants With Chronic Myeloid Leukemia (CML) (MK-4208-003/Tern701-1012/CARDINAL)

Condition(s) studied

Investigational drug(s) / intervention(s)

MK-4208: 40 mg and 100 mg oral tablets

Study summary

Researchers are looking for a new way to treat a blood cancer called chronic myeloid leukemia (CML). Researchers want to learn if MK-4208 (Tern-701) can treat this type of blood cancer.

The goal of this study is to learn about the safety of different doses (amounts) of MK-4208 (Tern-701) and if people tolerate them. Researchers also want to find the highest dose of MK-4208 (Tern-701) that people can tolerate and may work to treat blood cancer.

Eligibility

Primary outcome measure(s)

• Part 1: Incidence of Dose Limiting Toxicities (DLTs) During the First Cycle of Intervention — Up to 28 days
  A DLT is any of a prespecified list of adverse events (AEs) of a pre-specified severity that occur during Cycle 1 (up to 28 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 28 days.
• Parts 1, 2m and 3: Number of Participants with at Least One AE — Up to 3 years
  An AE is any untoward medical occurrence in a participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding that is determined to be clinically significant by the investigator), symptom, or disease (new or exacerbated) temporally associated with the use of trial intervention. The number of participants with at least one AE will be reported.
• Parts 1, 2m and 3: Number of Participants with at Least One Serious Adverse Event (SAE) — Up to 3 years
  An SAE is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening; Requires in-patient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Other situations determined to be SAEs by the investigator. The number of participants with at least one SAE will be reported.
• Parts 1, 2m and 3: Number of Participants who Discontinued Study Intervention Due to an AE — Up to 3 years
  An AE is any untoward medical occurrence in a participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding that is determined to be clinically significant by the investigator), symptom, or disease (new or exacerbated) temporally associated with the use of trial intervention. The number of participants who discontinued study intervention due to an AE will be reported.
• Parts 2, 2m and 3: Number of Participants with a Complete Hematologic Response (CHR) — Baseline and up to 3 years
  The hematologic response will be evaluated by hematology and differential blood count. A CHR is defined by meeting all the following criteria and lasting for at least 4 weeks: Peripheral blood white blood cell count \< 10 × 109/L ; Peripheral blood platelet count \< 450 × 109/L; No immature cells in peripheral blood, such as myelocytes, promyelocytes, blasts and immature cells, and a basophil level \< 5%; No symptoms or signs of the disease under trial, and the palpable splenomegaly has disappeared. The number of participants with a CHR will be reported.
• Parts 2, 2m and 3: Number of Participants with a Molecular response (MR) — Baseline and up to 3 years
  The MR will be evaluated for all participants, and peripheral blood will be collected and tested for breakpoint cluster region::Abelson (BCR::ABL1/ABLIS) using real-time quantitative polymerase chain reaction performed locally and centrally with validated polymerase chain reaction technology that has a sensitivity of at least 4.5 logs. An MR is defined as follows: MR1: BCR::ABL1IS \> 1% to 10%; MR2: BCR::ABL1IS \> 0.1% to 1%; MR3 (MMR): BCR::ABL1IS \> 0.01% to 0.1%; MR4.0: BCR::ABL1IS \> 0.0032% to 0.01%; MR4.5: BCR::ABL1IS \> 0.001% to 0.0032%, MR5: ≤ 0.001%. The number of participants with a MR will be reported.
• Parts 2, 2m and 3: Number of Participants who had Best Categorical Shift in BCR-ABL1 Transcript Levels From Baseline — Baseline and up to 3 years
  The number of participants who had best categorical molecular response shift on treatment relative to baseline will be reported.

Trial sites (54)

+ 14 more sites — see the full list on the official registry below.

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