1. Patients with cytological or histologically confirmed relapsed or refractory
hematologic malignancies (AML, CLL/SLL and lymphoma)
2. 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.
3. Amylase and lipase ≤1.5 × ULN
4. Electrolytes and uric acid levels within normal limits (WNL) or correctable with
5. 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.
1. Patients with bulky disease who require cytoreductive therapy.
2. 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.
3. Severe cardiovascular disease within 6 months of study entry, including any of the
- 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
- QTcF ≥ 450 msec on screening ECG.
4. 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).
5. Chronic or active hepatitis B or hepatitis C virus infection.
6. History of HIV infection.
7. 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.
8. Medications that are known to prolong the QT interval are prohibited on this study.