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
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- STATUS
- Recruiting
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- End date
- Feb 1, 2024
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- participants needed
- 60
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- sponsor
- M.D. Anderson Cancer Center
Summary
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).
Description
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.
Details
| Condition | Myelodysplastic Syndromes, Myeloproliferative Chronic Myelomonocytic Leukemia |
|---|---|
| Treatment | cytarabine, Azacitidine, cladribine, venetoclax |
| Clinical Study Identifier | NCT05365035 |
| Sponsor | M.D. Anderson Cancer Center |
| Last Modified on | 24 October 2022 |
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