Study Summary
This trial is studying the side effects and best dose of tagraxofusp, a drug that consists of human interleukin 3 (IL3) linked to a toxic agent called DT388, and decitabine, a chemotherapy drug, in treating patients with chronic myelomonocytic leukemia.
Eligible Conditions
- Chronic Myelomonocytic Leukemia
- Myelodysplastic/Myeloproliferative Neoplasms
- Chronic Myelomonocytic Leukemia (CMML)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: After 2 cycles of therapy (1 cycle = 28 days)
Day 28
Overall response (OR) (Phase II)
Day 28
Maximum tolerable dose (Phase I)
Day 28
Incidence of dose limiting toxicities (Phase I)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment (decitabine, tagraxofusp-erzs)
1 of 1
Experimental Treatment
64 Total Participants · 1 Treatment Group
Primary Treatment: Tagraxofusp-erzs · No Placebo Group · Phase 1 & 2
Treatment (decitabine, tagraxofusp-erzs)Experimental Group · 2 Interventions: Tagraxofusp-erzs, Decitabine · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after 2 cycles of therapy (1 cycle = 28 days)
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,307 Total Patients Enrolled
Guillermo M BravoPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
160 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be 18 years of age or older to participate.
You have been diagnosed with CMML-1 or CMML-2, by World Health Organization criteria and have had no response to 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine-cedazuridine), experienced relapse or progression after any number of cycles.
You are part of Cohort A with CMML-1 or CMML-2 and have not responded to at least 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine-cedazuridine) nor experienced relapse or progression after any number of cycles.
You have CMML-1 or CMML-2 and intermediate-2 or high risk International Prognostic Scoring System (IPSS) and are HMA naïve.
The patient exhibits an Eastern Cooperative Oncology Group (ECOG) performance status ranging from 0-2.
Your LVEF is 50% or greater, as confirmed by a multigated acquisition scan or 2-D ECHO within the last month; additionally, your 12-lead ECG demonstrates no clinically significant anomalies.
Your serum creatinine is lower than 1.5 mg/dL (or 114 umol/L).
You have an albumin level of at least 3.2 grammes per decilitre, or 32 grams per litre in your blood, and you haven't received intravenous albumin within the last three days.
Your total bilirubin is at or below 1.5 mg/dL (or 26 umol/L).
Your AST and ALT levels are equal to or less than 2.5 times the ULN.
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Conditions
Cancer Related
Treatments