A Study of GFH009 in Patients With Hematologic Malignancies
Hematologic Malignancies
About this trial
This is an interventional treatment trial for Hematologic Malignancies focused on measuring Acute myeloid leukemia, lymphoma, relapsed, refractory, CDK9 inhibitor, GFH009, venetoclax, azacitidine
Eligibility Criteria
Inclusion Criteria
- Patients with cytological or histologically confirmed relapsed or refractory hematologic malignancies (AML, CLL/SLL and lymphoma)
Total bilirubin ≤ 1.5 × upper limit of normal (ULN) except for patients with Gilbert's syndrome, who are included if total bilirubin is < 3 × ULN or if direct bilirubin is < 1.5 × ULN.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN. For those with hepatic metastases, AST and ALT ≤ 5 × ULN.
- Amylase and lipase ≤1.5 × ULN
- Electrolytes and uric acid levels within normal limits (WNL) or correctable with medical intervention
- For women of childbearing potential, must consent to use two highly effective methods (i.e, total abstinence, placement of an intrauterine device) of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug; Men with a partner of childbearing potential, must consent to use two highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug.
Exclusion Criteria
- Patients with bulky disease who require cytoreductive therapy.
- Symptomatic central nervous system metastases or primary lymphoma such as primary CNS lymphoma, leptomeningeal disease, or spinal cord compression. Patients with asymptomatic CNS metastases who are radiologically and neurologically stable ≥ 4 weeks following CNS-directed therapy and are on a stable or decreasing dose of corticosteroids are eligible for study entry.
Severe cardiovascular disease within 6 months of study entry, including any of the following:
- Clinically significant heart disease such as congestive heart failure requiring treatment (NYHA class III or IV), LVEF < 45% as determined by MUGA scan or echocardiogram (ECHO), (if just with historical occasional low LVEF but without any symptoms or relevant medical history, and the LVEF at screening is > 45%, the subject is eligible), or clinically significant arrythmia.
- History/evidence of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting).
- QTcF ≥ 450 msec on screening ECG.
- Concurrent malignancy within 5 years (for AML patients, 2 years) prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle invasive urothelial carcinoma (excluding T1 lesions and CIS).
- Chronic or active hepatitis B or hepatitis C virus infection.
- History of HIV infection.
- Concomitant medications that are strong CYP3A4 inhibitors and strong inducers within 7 days of first dose. Avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pomelos, star citrus fruits or St. John's wort within 7 days of first dose.
- Medications that are known to prolong the QT interval are prohibited on this study.
Sites / Locations
- O'Neal Comprehensive Cancer Center, University of AlabamaRecruiting
- Ochsner Clinic Foundation
- Clinical Research Alliance, Inc.Recruiting
- New York - Presbyterian Hospital
- Bon Secours St. Francis Cancer CenterRecruiting
- MD AndersonRecruiting
- The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
- Anhui Provincial Hospital
- Affiliated Cancer Hospital of Chongqing University
- Cancer prevention and treatment center of Sun Yat sen UniversityRecruiting
- Guangdong Provincial People's HospitalRecruiting
- Affiliated Hospital of Hebei UniversityRecruiting
- Henan Cancer HospitalRecruiting
- The First Affiliated Hospital of Soochow UniversityRecruiting
- The First Affiliated Hospital Of Nanchang UniversityRecruiting
- Shengjing Hospital Affiliated to China Medical UniversityRecruiting
- Linyi Cancer HospitalRecruiting
- Blood disease hospital, Chinese Academy of Medical ScienceRecruiting
- The Second Affiliated hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group 1. Dose escalation in patients with relapsed/refractory AML
Group 2. Dose escalation in patients with relapsed/refractory CLL/SLL or lymphoma
AML Patients relapsed/refractory to vene and who will be treated with GFH in combo with vene & aza
Group 3. Patients with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens