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A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts

StatusRecruiting
PhasePhase 2
Started2022-09-23
View on ClinicalTrials.gov ↗

Amendment history

2026-06-03
Study Status v14
Re-verified, no change to tracked fields
2025-12-29
Study Status v13
Primary completion date2025-12-01→2027-12-31
Completion date2025-12-01→2027-12-31
2025-10-20
Study Status, Study Description, Eligibility, Contacts/Locations, IPDSharing v12
Eligibility criteria+539 characters
Inclusion Criteria: Age >/= 18 years. Diagnosis of MDS or CMML by WHO and: MDS relapsed cohort (Cohort A): MDS with IntIPSS-2R orscore High risk IPSS>3.5 and >5% blasts with no response after 6 cycles of azacitidine, decitabine, guadecitabine, CC-486 or ASTX727 (decitabine/cedazuridine) or relapse or progress [...] nse after 6 cycles of azacitidine, decitabine, guadecitabine, CC-486 or ASTX727 (decitabine/cedazuridine) or relapse or progress [...] number of cycles MDS HMA-naïve cohort (Cohort C): MDS with IntIPSS-2R orscore High risk by IPSS>3.5 and >/= 10% blasts OR diagnosis CMML HMA-naïve cohort (Cohort [...] [...]
Study description+147 characters
[...] abnormality (other than monosomy Y). Secondary Objectives: To evaluate responses by 2015 IWG MDS/MPN response criteria in patients with MDS/MPN and by 2023 IWG response criteria in all patients (Appendix). To assess overall survival (OS), duration of response, leuke [...]
Study sitescontacts updated at 1 of 1 site
2025-09-30
Study Status, Contacts/Locations, IPDSharing v11
Study sitescontacts updated at 1 of 1 site
2025-05-14
2 amendments v9-v10
2 re-verifications since 2025-04-03, no change to tracked fields
Show 8 earlier versions
2024-09-26
Study Status v8
Primary completion date2025-02-01→2025-12-01
Completion date2025-02-01→2025-12-01
2024-06-02
Study Status v7
Re-verified, no change to tracked fields
2024-04-24
Study Status, Eligibility v6
Eligibility criteria-278 characters
[...] ibitions and restrictions specified in the protocol. Patient (or patient's legally authorized representative) must have signed an informed consent document indicating th [...] , on a case-by-case basis and after discussion with the PI. English and Non-English speaking patients will be allowed Exclusion Criteria: Uncontrolled infection not adequately re [...] ional agent or chemotherapy, radiotherapy, or immunotherapy. Patients known to be positive for hepatitis B surface antigen expression or with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C wit [...]
2024-01-11
Study Status v5
Primary completion date2024-02-01→2025-02-01
Completion date2024-02-01→2025-02-01
2023-04-05
3 amendments v2-v4
3 re-verifications since 2022-10-12, no change to tracked fields
2022-09-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-10-30→confirmed 2022-09-23
Study sitesdetails revised at 1 of 1 site
2022-05-03
Original filing
To learn if the combination of cladribine, cytarabine, venetoclax, and azacitidine can help to control higher-risk myelodysplastic syndrome (MDS) with excess blasts and/or higher-risk chronic myelomonocytic leukemia (CMML).
Trial Details
NCT Number NCT05365035
Lead Sponsor M.D. Anderson Cancer Center
Conditions Myelodysplastic Syndromes, Myeloproliferative Chronic Myelomonocytic Leukemia
Enrollment 60 participants
Start Date 2022-09-23
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-05