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Clinical Trials List

Protocol NumberPKRPC001
NCT Number(ClinicalTrials.gov Identfier)NCT05429632
Active

2023-01-02 - 2029-06-01

Phase III

Recruiting4

Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT

  • Trial Applicant

    Pharmaceutical Research Associates Taiwan Inc.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 賴冠銘 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator - - Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator - - Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Adult Acute Myeloid Leukemia

Objectives

Primary purpose: To compare the efficacy of mocravimod with placebo Key secondary purposes: ‧ Compare the effect of mocravimod with placebo on overall survival (OS) ‧ Evaluate the efficacy of the second dose of mocravimod compared with placebo (if applicable) Other minor ‧ To evaluate the sustained efficacy of mocravimod compared to placebo ‧ Evaluate the effect of mocravimod on relapse compared with placebo ‧ To evaluate the effect of mocravimod on the occurrence of non-relapse death compared with placebo ‧ Compare the effect of the second dose of mocravimod on overall survival (OS) (if applicable) ‧ To evaluate the effect of mocravimod on graft-versus-host disease (GvHD) compared with placebo ‧ Evaluate the safety and tolerability of mocravimod ‧ Assessment of quality of life (QoL) after 12 months of treatment period exploratory purpose ‧ Explore the impact of mocravimod on implantation dynamics ‧ Explore the impact of mocravimod on immune system responses to various events ‧ Explore follow-up treatments after relapse ‧ Evaluate the pharmacokinetics (PK) of mocravimod and evaluate the relationship between pharmacokinetics/pharmacodynamics (PK/PD) for efficacy and safety ‧ Evaluate cyclosporine A (CsA) with mocravimod and tacrolimus (TAC) with mocravim ‧ Explore the relationship between mocravimod and hierarchical and non-hierarchical groups ‧ To explore the response and overall survival (OS) of subjects with FLT3 mutations or other genetic mutations ‧ Explore the impact of mocravimod on in-depth response

Test Drug

mocravimod

Active Ingredient

mocravimod (KRP203)

Dosage Form

capsule

Dosage

1mg

Endpoints

main indicators
-Relapse-free survival (RFS)
Key Secondary Metrics
-Overall survival (OS)
-Relapse-free survival (RFS)

Inclution Criteria

Inclusion Criteria:

Diagnosis of AML (excluding acute promyelocytic leukemia) according to the WHO 2022 classification of AML and related precursor neoplasm, including AML with myelodysplasia-related gene mutations
European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, [CRi] is also allowable
Planned allogeneic HCT from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned use of haploidentical donor using PBSC graft
Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5
Planned use of CsA-based or TAC-based GvHD prophylaxis
age ≥ 18 years and ≤ 75 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

Exclusion Criteria:

Use of anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis
Diagnosis of macular edema during screening
Cardiac/pulmonary/hepatic/renal dysfunction
Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); or total bilirubin > 1.5 mg/dL
Renal dysfunction with estimated creatinine clearance < 45 mL/min by the Cockcroft-Gault formula

The Estimated Number of Participants

  • Taiwan

    12 participants

  • Global

    366 participants

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