Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
This is a Phase 1 study investigating the safety and efficacy of Danvatirsen as a monotherapy followed by combination with Venetoclax in patients with relapsed/refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML).
Funding Source: FDA OOPD
Eligibility criteria
Qualifiers
Subjects must be at least 18 years of age at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF; and be able to meet all study requirements
Morphologically confirmed diagnosis of AML or MDS in accordance with World Health Organization (WHO) diagnostic criteria
Subjects with relapsed/refractory AML who are refractory or relapsed to all conventional therapy and do not have any FDA approved or standard therapeutic options & subjects with intermediated/high/very high IPSS-R MDS who are refractory or relapsed to at least 2 cycles of hypomethylating agent based therapy (azacitidine / decitabine based) OR patients with rapid progression of disease regardless of number of cycles of therapy
At least 3 months from Allogenic stem cell transplantation and no clinical sign of active graft vs host disease (GVHD)
Disqualifiers
Acute Promyelocytic Leukemia
Low or very low risk MDS by IPSS-R after failure/progression of first line therapy with hypomethylating agents
Active, uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are eligible. Use of prophylactic anti-microbials per institutional standards is allowed
Active documented central nervous system (CNS) leukemia. Patients with a known history of CNS leukemia will be eligible if they have at least two most recent consecutive LPs showing clearance of CNS disease and no active/progressive symptoms thought to be related to the CNS disease
Trial design
Treatments tested in this trial
- Danvatirsen
- Danvatirsen + Venetoclax
Treatment groups
38 Participants
are divided into 2 treatment groupsLocations
2Montefiore Medical Center10467, The BronxNew York, United States
M.D. Anderson Cancer Center, Department of Leukemia77030, HoustonTexas, United States
Sponsors and collaborators
Montefiore Medical Center
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
Flamingo Therapeutics NV
Collaborator
Source ClinicalTrials.gov