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

ConditionsMyelodysplastic Syndromes Myeloproliferative Chronic Myelomonocytic Leukemia

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >/= 18 years.

MDS relapsed cohort (Cohort A): MDS with IPSS-R score >3.5 and >5% blasts with no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine/cedazuridine) or relapse or progression after any number of cycles

CMML relapsed cohort (Cohort B): CMML 1 or 2 with no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine/cedazuridine) or relapse or progression after any number of cycles

MDS HMA-naïve cohort (Cohort C): MDS with IPSS-R score >3.5 and >/= 10% blasts

Disqualifiers

Uncontrolled infection not adequately responding to appropriate antibiotics

New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF <50% by echocardiogram or multigated acquisition (MUGA) scan.

History of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias.

Female patients who are pregnant or lactating.

Trial design

Design model

Single group

Treatments tested in this trial

Cladribine
Drug
Given by Vein (IV)
Cytarabine
Drug
Given under the skin; subcutaneous injection (SQ)
Venetoclax
Drug
Given by PO
Azacitidine
Drug
Given by IV or subcutaneous injection (SQ)

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: cladribine, cytarabine, venetoclax, and azacitidineExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

To establish the overall survival (OS).

Time frame

through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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