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CDK9 inhibitor
GFH009 for Blood Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Genfleet Therapeutics (Shanghai) Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN. For those with hepatic metastases, AST and ALT ≤ 5 × ULN
Patients with cytological or histologically confirmed relapsed or refractory hematologic malignancies (AML, CLL/SLL and lymphoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new drug to treat cancer, and will explore its safety and effectiveness.
Who is the study for?
This trial is for adults with certain blood cancers like AML, CLL/SLL, and lymphoma that have come back or didn't respond to treatment. They must have normal levels of bilirubin (unless they have Gilbert's syndrome), liver enzymes, amylase, lipase, and stable electrolytes. Women who can get pregnant and men with partners who can get pregnant must use two effective birth control methods during the study.Check my eligibility
What is being tested?
The trial tests GFH009 alone in patients with relapsed/refractory acute myeloid leukemia (AML) or lymphomas. It also tests GFH009 combined with venetoclax and azacitidine in AML patients resistant to venetoclax-based treatments. The goal is to see how safe it is and if it helps against these cancers.See study design
What are the potential side effects?
Possible side effects include reactions related to liver function changes, digestive enzyme alterations, potential heart issues due to QT interval prolongation on ECGs (a type of heart rhythm problem), as well as general risks associated with cancer drugs such as fatigue or increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver enzymes are within the required limits.
Select...
My cancer, such as AML, CLL/SLL, or lymphoma, has returned or is not responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability of GFH009: Dose Limiting Toxicities (DLTs)
Safety and Tolerability of GFH009: adverse events (AEs)
Secondary outcome measures
Efficacy: CR
Efficacy: DOR
Efficacy: PFS
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Group 2. Dose escalation in patients with relapsed/refractory CLL/SLL or lymphomaExperimental Treatment1 Intervention
Group II: Group 1. Dose escalation in patients with relapsed/refractory AMLExperimental Treatment1 Intervention
Group III: AML Patients relapsed/refractory to vene and who will be treated with GFH in combo with vene & azaExperimental Treatment1 Intervention
Group 3. Patients with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens
Find a Location
Who is running the clinical trial?
Genfleet Therapeutics (Shanghai) Inc.Lead Sponsor
1 Previous Clinical Trials
65 Total Patients Enrolled
Zhejiang Genfleet Therapeutics Co., Ltd.Lead Sponsor
9 Previous Clinical Trials
693 Total Patients Enrolled
Sellas Life Sciences GroupIndustry Sponsor
8 Previous Clinical Trials
668 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.My liver enzymes are within the required limits.I have a large tumor (10 cm or larger) that needs treatment to reduce its size.I have had a heart attack or other serious heart problems.I have stable brain metastases and haven't needed more steroids for at least 4 weeks.I haven't had serious heart problems in the last 6 months.I haven't had any cancer except for certain skin, cervical, prostate, breast, or superficial bladder cancers in the last 5 years.I am not on medications that affect heart rhythm, except for antifungal meds if I have AML.I agree to use two effective birth control methods during and 90 days after treatment.My electrolyte and uric acid levels have been stable for at least 3 days.I haven't taken strong medication or consumed certain citrus fruits and St. John's wort in the last week.My cancer, such as AML, CLL/SLL, or lymphoma, has returned or is not responding to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: AML Patients relapsed/refractory to vene and who will be treated with GFH in combo with vene & aza
- Group 2: Group 1. Dose escalation in patients with relapsed/refractory AML
- Group 3: Group 2. Dose escalation in patients with relapsed/refractory CLL/SLL or lymphoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is GFH009 a safe choice for individuals?
"GFH009's safety was scored a 1 since this is an early-phase trial, which has only demonstrated limited efficacy and data on its protection."
Answered by AI
Are there any open spots in this trial currently available?
"Affirmative. Clinicaltrials.gov displays that the research study, which was first made available on May 10th 2021, is currently recruiting participants. Up to 80 individuals are needed to be recruited from 4 distinct medical sites."
Answered by AI
What is the enrolling capacity of this clinical trial?
"This study requires 80 qualified individuals to enroll. For those that meet the eligibility criteria, they can choose between Clinical Research Alliance, Inc. in Lake Success or New york - Presbyterian Hospital in New York, Texas as their trial site."
Answered by AI
Are there many medical centers in this state currently running the clinical trial?
"As of now, this research initiative is operating in 4 separate medical sites. These are based in Lake Success, New york and Houston as well as other locales within the vicinity. To better accommodate you, it's advised to pick a clinic near your residence so travel can be reduced if taking part."
Answered by AI
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