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Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04849351
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Hutchmed ( Hutchison Medipharma Limited )

Study Description
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Brief Summary:
A Multi-center, Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of HMPL-689 in Patients with Relapsed/Refractory Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL)

Condition or disease Intervention/treatment Phase
Marginal Zone Lymphoma Follicular Lymphoma Drug: HMPL-689 Phase 2

Detailed Description:

This is a multi-center, single-arm, open-label clinical study to evaluate the oral therapy with HMPL-689 in patients with relapsed / refractory MZL and FL. Relapse / refractory is defined as such a situation when a patient has not achieved response (CR or PR) after the latest line of systemic treatment, or has disease progress (PD) or relapse after achieving response. Two (2) cohorts of patients will be enrolled in this study:

Cohort 1: approximately 81 patients with histologically confirmed MZL

Cohort 2: approximately 104 patients with histologically confirmed FL (pathological grade 1-3a)

All patients are to receive monotherapy of HMPL-689 30 mg once a day (QD) continuously in 28-day treatment cycles until PD / recurrence, patient death, intolerable toxicity, initiation of other antitumor therapy, the patient unable to further benefit from the study treatment as judged by the investigators, the patient or his/her legal representative's request to withdraw from the clinical study treatment, the patient lost to follow-up or end of the study, whichever comes first.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of HMPL-689 in Patients With Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Relapsed/Refractory MZL and FL
Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
 Drug: HMPL-689
All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles.
Other Name: Phosphatidylinositol 3-kinase-δ inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Baseline up to the last patient has completed 12 months after treatment. ]
    Defined as the proportion of patients with CR or PR


Secondary Outcome Measures :
  1. Complete response (CR) rate [ Time Frame: Baseline up to the last patient has completed 12 months after treatment. ]
    Defined as the proportion of patients with CR.

  2. Progression-free survival (PFS) [ Time Frame: Baseline up to the last patient has completed 12 months after treatment. ]
    Defined as the time from the first dose of HMPL-689 to occurrence of PD or death, whichever comes first.

  3. Time to response (TTR) [ Time Frame: Baseline up to the last patient has completed 12 months after treatment. ]
    Defined as the time from the first dose of HMPL-689 to the first objective response.

  4. Duration of response (DoR) [ Time Frame: Baseline up to the last patient has completed 12 months after treatment. ]
    Defined as the time from the initial objective response to disease recurrence, progression or death.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years;
  2. Patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2;
  4. At least one measurable lesion by computerised tomography (CT) / magnetic resonance imaging (MRI) (the longest diameter of nodal lesion > 1.5 cm or extranodal lesion > 1 cm);
  5. Expected survival of more than 12 weeks;

Exclusion Criteria:

  1. Having lymphoma with central nervous system (CNS) or cerebral pia mater invasion
  2. Known histologic transformation to aggressive lymphomas such as diffuse large B-cell lymphoma (DLBCL);
  3. Prior use of any phosphatidylinositol 3-kinase (PI3K) inhibitor or Bruton's tyrosine kinase (BTK) inhibitor
  4. Inadequate organ function of liver and kidney
  5. Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
  6. Having received systemic antitumor therapy or radiotherapy within 4 weeks prior to the first dose of the investigational product
  7. Toxicity of previous antitumor therapy not recovered to CTCAE grade ≤ 1, except alopecia, prior to the first dose of the investigational product
  8. Complicated with uncontrolled systemic infection requiring intravenous antibiotic treatment
  9. Pregnant (positive serum pregnancy test) or lactating women
  10. Any other disease, metabolic abnormality, physical examination abnormality or clinically significant laboratory test abnormality, one disease or state providing a reason to suspect that the subject is not suitable for HMPL-689 at the investigator's discretion, or one condition that will affect interpretation of the study results or bring the subject at high risk.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04849351


Contacts
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Contact: Xianlin Duan 021-20678852 xianlind@hmplglobal.com
Contact: Meiping Kong 86 21 2067 3233 meipingk@hmplglobal.com

Locations
Show Show 36 study locations
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Principal Investigator: junning Cao, Ph.D Fudan University
Principal Investigator: Zhiming Li, post-doc Sun Yat-sen University
More Information
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT04849351    
Other Study ID Numbers: 2020-689-00CH3
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hutchmed ( Hutchison Medipharma Limited ):
Marginal Zone Lymphoma
Follicular Lymphoma
Phosphatidylinositol 3-kinase inhibitor
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell