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Anti-metabolite
Tagraxofusp + Decitabine for Chronic Myelomonocytic Leukemia
Phase 1 & 2
Recruiting
Led By Guillermo M Bravo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is >= 18 years old
Diagnosis of myelodysplastic/myeloproliferative neoplasm (MDS/MPN) subtype chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 2 cycles of therapy (1 cycle = 28 days)
Awards & highlights
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.
Who is the study for?
This trial is for adults with chronic myelomonocytic leukemia (CMML) who haven't tried hypomethylating agents or have no response after 6 cycles of such treatments. They should be in good heart health, have acceptable organ function, and not be pregnant. Participants must agree to use contraception and can't join if they've had recent other cancer treatments, significant heart or lung disease, active infections like HIV or hepatitis B/C, or are on certain immunosuppressants.Check my eligibility
What is being tested?
The trial is testing the combination of Tagraxofusp-erzs and Decitabine for treating CMML. Tagraxofusp targets cancer cells with a toxin linked to IL3 while Decitabine interferes with cell growth. The study aims to find the best dose and see how effective this combo is at controlling the disease.See study design
What are the potential side effects?
Possible side effects include reactions where Tagraxofusp is infused into the body, general fatigue, blood disorders that may affect clotting and immunity levels, liver issues reflected by changes in specific tests (AST/ALT), muscle pain indicated by creatine kinase levels increase.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with chronic myelomonocytic leukemia.
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I am able to care for myself and perform daily activities.
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My heart pumps well and my recent heart tests show no significant issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 2 cycles of therapy (1 cycle = 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 2 cycles of therapy (1 cycle = 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities (Phase I)
Maximum tolerable dose (Phase I)
Overall response (OR) (Phase II)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (decitabine, tagraxofusp-erzs)Experimental Treatment2 Interventions
Patients receive decitabine IV over 60 minutes on days 1-5, and tagraxofusp-erzs IV over 15 minutes on days 1-3. Cycles of decitabine repeat every 28 days in the absence of disease progression or unacceptable toxicity. Treatment with tagraxofusp-erzs repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tagraxofusp-erzs
2020
Completed Phase 2
~10
Decitabine
2004
Completed Phase 3
~1680
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,282 Total Patients Enrolled
Guillermo M BravoPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
160 Total Patients Enrolled
Guillermo M Bravo, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or might have cancer that has spread to my brain or spinal cord.I am currently receiving treatment for an active cancer.I am either in the relapsed group or have never had HMA treatment.I have a serious lung condition that is not under control.I need oxygen support to breathe.I agree to use birth control during and for 2 months after the study.I am 18 years old or older.I have lasting side effects from past chemotherapy that are moderate to severe, except for hair loss, nausea, or tiredness.I have been diagnosed with chronic myelomonocytic leukemia.I have CMML and my treatment hasn’t worked after 6 cycles or my condition got worse.I have not had chemotherapy, radiation, or biologic therapy in the last 14 days.I am able to care for myself and perform daily activities.I have a serious heart condition.I have been treated with tagraxofusp or am allergic to it.I am taking hydroxyurea only in certain situations as allowed.My heart pumps well and my recent heart tests show no significant issues.I have an active or chronic hepatitis B or C infection.I am on immunosuppressive therapy for GVHD, but not using corticosteroids or tacrolimus.I do not have any uncontrolled illnesses like infections or severe mental health issues.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (decitabine, tagraxofusp-erzs)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings in this research venture at present?
"Affirmative. According to the information on clinicaltrials.gov, this medical trial is currently searching for volunteers and was posted on March 4th 2022 with no subsequent alterations as of yet. The researchers aim to recruit 64 individuals from a single location."
Answered by AI
Is there a precedent of clinical trials using Tagraxofusp-erzs?
"Currently, 108 medical trials are in progress to evaluate the efficacy of Tagraxofusp-erzs with 15 studies already in Phase 3. The preponderance of research projects for this medication is located in Philadelphia, Pennsylvania though there are 1507 centres conducting clinical tests across the world."
Answered by AI
What maladies has Tagraxofusp-erzs been demonstrated to alleviate?
"Tagraxofusp-erzs is a viable treatment for ipss intermediate-2 risk category and other diseases like refractory anemias, anemia, and high risk ipss."
Answered by AI
How many participants are involved in this experiment?
"Affirmative. According to the clinicaltrials.gov database, this medical experiment is actively seeking participants since its inaugural posting on March 4th 2022 and most recent update occurring at the same time. Specifically, 64 individuals must be recruited from a single research centre."
Answered by AI
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