Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML (NCT04588922)
A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed/Refractory Hematologic Malignancies and High-Risk Newly Diagnosed AML
🩺 Plain-English Summary (8th-Grade Level)
SLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with relapsed/refractory AML, Group 2 in patients with relapse/refractory lymphoma/CLL/SLL). The safety, tolerability, and antitumor activity of SLS009 in combination with venetoclax and azacitidine in patient with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens are being assessed in five cohorts of the expansion Group 3. Groups 4 and 5 have been added to evaluate efficacy, safety, and tolerability of GFH009 in combination with venetoclax and azacitidine in newly diagnosed AML patients who are less likely to benefit from standard induction treatment with venetoclax plus HMA only regimens.
Who can join: Review the eligibility criteria below.
Location: O'Neal Comprehensive Cancer Center, University of Alabama — Birmingham, Alabama
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- O'Neal Comprehensive Cancer Center, University of Alabama — Birmingham, Alabama
- City of Hope - Phoenix — Goodyear, Arizona
- City of Hope National Medical Center — Duarte, California
- Moffitt Cancer Center — Tampa, Florida
- City of Hope - Atlanta — Newnan, Georgia
- City of Hope - Chicago — Zion, Illinois
- Ochsner Clinic Foundation — New Orleans, Louisiana
- Clinical Research Alliance, Inc. — Lake Success, New York
- New York - Presbyterian Hospital — New York, New York
- UNC School of Medicine, Division of Hematology — Chapel Hill, North Carolina
- Bon Secours St. Francis Cancer Center — Greenville, South Carolina
- Baylor Scott & White Health — Dallas, Texas
- MD Anderson — Houston, Texas
- The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui
- Anhui Provincial Hospital — Hefei, Anhui
- Affiliated Cancer Hospital of Chongqing University — Chongqing, Chongqing Municipality
- Cancer prevention and treatment center of Sun Yat sen University — Guangzhou, Guangdong
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong
- Affiliated Hospital of Hebei University — Baoding, Hebei
- Henan Cancer Hospital — Zhengzhou, Henan
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu
- The First Affiliated Hospital Of Nanchang University — Nanchang, Jiangxi
- Shengjing Hospital Affiliated to China Medical University — Shenyang, Liaoning
- Linyi Cancer Hospital — Linyi, Shandong
- Blood disease hospital, Chinese Academy of Medical Science — Tianjin, Tianjin Municipality
📞 Contact the Study Coordinator
Phone: (646) 565-3564
Email: jdean@sellaslife.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hematologic Malignancies
- Giving Chemotherapy for a Shortened Amount of Time Before a Stem Cell Transplantation — New York, New York
- A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies — San Francisco, California
- Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device — Milwaukee, Wisconsin
- A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant — Basking Ridge, New Jersey
- Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy — Duarte, California
- PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV) — Duarte, California
Explore by condition: All Hematologic Malignancies clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.