M.D. Anderson Cancer Center
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).
Myelodysplastic Syndromes
Myeloproliferative Chronic Myelomonocytic Leukemia
Cladribine
Cytarabine
Venetoclax
Azacitidine
Phase 2
Primary Objectives: To determine the efficacy, safety and tolerability of the combination of cladribine, cytarabine and venetoclax in higher-risk MDS with excess blasts and higher-risk CMML. MDS relapsed cohort (Cohort A, N=20): MDS with Int-2 or High risk IPSS and >5% blasts with no response after 6 cycles of azacitidine, decitabine, guadecitabine, CC-486 or ASTX727 (decitabine/cedazuridine) or relapse or progression after any number of cycles CMML relapsed cohort (Cohort B, N=10): CMML 1 or 2 with no response after 6 cycles of azacitidine, decitabine, guadecitabine, CC-486 or ASTX727 (decitabine/cedazuridine) or relapse or progression after any number of cycles MDS HMA-naïve cohort (Cohort C, N=20): MDS with Int-2 or High risk by IPSS and >10% blasts OR diagnosis CMML HMA-naïve cohort (Cohort D, N=10): CMML-2; OR CMML-1 with at least one of the following high-risk features: extramedullary disease, splenomegaly of >5cm below costal margin, platelets <100x109/L, Hgb level <10g/dL, WBC >13x109/L, clonal cytogenetic abnormality (other than monosomy Y). Secondary Objectives: To assess overall survival (OS), duration of response, leukemia-free survival (LFS), and relapse-free survival (RFS). To evaluate proportion of transplant-candidate patients bridged to allogeneic stem-cell transplant. Correlative studies including correlation of response with disease subtype and genomic profile. To evaluate changes in clonal composition and VAF of identified mutations with therapy.}}
Study Type : | Interventional |
Estimated Enrollment : | 60 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | 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 |
Actual Study Start Date : | September 23, 2022 |
Estimated Primary Completion Date : | February 1, 2025 |
Estimated Study Completion Date : | February 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: cladribine, cytarabine, venetoclax, and azacitidine Participants will receive cladribine, cytarabine, and venetoclax for 2 cycles and then azacitidine and venetoclax for 2 cycles. Participants will repeat this pattern of 2 cycles each for up to a total of 18 |
Drug: Cladribine Drug: Cytarabine Drug: Venetoclax Drug: Azacitidine |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
M D Anderson Cancer Center
Houston, Texas, United States, 77030