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HMPL-689 for Lymphoma
Phase 1
Waitlist Available
Led By Nilanjan Ghosh, MD
Research Sponsored by Hutchison Medipharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 1 day 1 30 min pre-dose until cycle 2 day 1 30 min pre dose (escalation) from cycle 1 day 1 30 min pre-dose to cycle 5 day 1 pre-dose 30 min (expansion) (cycle is 28 days)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, HMPL-689, to see if it is safe and effective in treating patients with relapsed or refractory lymphomas.
Who is the study for?
This trial is for patients with certain types of lymphoma that have relapsed or are not responding to standard treatments. Participants should be in relatively good physical condition (ECOG status 0 or 1) and expected to live more than 24 weeks. They must not have severe organ dysfunction, recent major surgery, heart issues like congestive heart failure, a history of significant liver disease, or any other condition that could interfere with the study.
What is being tested?
The trial is testing HMPL-689's safety and how it's processed by the body in those with specific lymphomas that haven't responded well to other treatments. It's an open-label study where everyone knows what treatment they're getting, starting with small doses that increase over time.
What are the potential side effects?
While specific side effects for HMPL-689 aren't listed here, common ones for cancer drugs include nausea, fatigue, risk of infection due to low blood cell counts, liver problems which might show up as yellowing skin or eyes (jaundice), and potential heart rhythm issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from cycle 1 day 1 30 min pre-dose until cycle 2 day 1 30 min pre dose (escalation) from cycle 1 day 1 30 min pre-dose to cycle 5 day 1 pre-dose 30 min (expansion) (cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from cycle 1 day 1 30 min pre-dose until cycle 2 day 1 30 min pre dose (escalation) from cycle 1 day 1 30 min pre-dose to cycle 5 day 1 pre-dose 30 min (expansion) (cycle is 28 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of adverse events as evaluated by the NCI CTCAE v5.0 grade
Secondary study objectives
Area under the concentration-time curve in a selected time interval (AUC0-t)
Objective response rate (ORR) defined as the proportion of patients who have a CR or PR
maximum plasma concentration (Cmax)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All patients take HMPL-689 taken daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HMPL-689
2017
Completed Phase 1
~250
Find a Location
Who is running the clinical trial?
Hutchison Medipharma LimitedLead Sponsor
101 Previous Clinical Trials
13,519 Total Patients Enrolled
7 Trials studying Lymphoma
680 Patients Enrolled for Lymphoma
HutchmedLead Sponsor
36 Previous Clinical Trials
6,426 Total Patients Enrolled
6 Trials studying Lymphoma
395 Patients Enrolled for Lymphoma
Nilanjan Ghosh, MDPrincipal InvestigatorAtrium Health Levine Cancer Institute
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