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Chronic Myelomonocytic LeukemiaPhase 1/2NCT05038592

Phase I/II Study of Tagraxofusp in Combination With Decitabine for Patients With Myelomonocytic/Myeloproliferative Neoplasm and High Risk Myelodysplastic Syndromes

A Phase 1/2 study testing Decitabine and Tagraxofusp-erzs in people with Chronic Myelomonocytic Leukemia and Chronic Myelomonocytic Leukemia-1, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase I/II trial studies the side effects, best dose, and effect of tagraxofusp and decitabine in treating patients with chronic myelomonocytic leukemia. Tagraxofusp consists of human interleukin 3 (IL3) linked to a toxic agent called DT388. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Decitabine and Tagraxofusp-erzs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
4 Mar 2022to 29 Jan 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant is ≥ 18 years old
  • Diagnosis of myelodysplastic/myeloproliferative neoplasm (MDS/MPN) according to World Health Organization (WHO) and:
  • Phase 1 dose escalation portion: CMML-1 or CMML-2 by WHO or higher-risk MDS (defined as IPSS-Revised score >3.5 or with TP53 mutations) with >5% blasts or MDS/MPN (other than CMML) with >5% bone marrow blasts and no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine-cedazuridine) or relapse or progression after any number of cycles
  • Phase 2 dose expansion portion:
  • Relapsed cohort (Cohort A): CMML-1 or CMML-2 or higher-risk MDS (defined as IPSS-Revised score >3.5 or with TP53 mutations) with >5% blasts or MDS/MPN (other than CMML) with >5% bone marrow blasts by WHO and no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine-cedazuridine) or relapse or progression after any number of cycles
  • Hypomethylating agents (HMA) naive cohort (Cohort B): previously untreated CMML-1 or CMML-2 and intermediate-2 or high-risk IPSS or higher-risk MDS (defined as IPSS-Revised score >3.5 or with TP53 mutations) with >5% blasts or MDS/MPN (other than CMML) with >5% bone marrow blasts.
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  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
  • Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition scan or 2-dimensional (2-D) echocardiogram (ECHO) within 28 days prior to start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG)
  • Serum creatinine ≤ 1.5 mg/dL (or ≤ 114 umol/L)
  • Serum albumin ≥ 3.2 g/dL (or ≥ 32 g/L) in the absence of receipt of (IV) albumin within the previous 72 hours
  • Total Bilirubin =< 1.5 mg/dL (or ≤ 26 umol/L)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN)
  • Creatine kinase (CK) ≤ 2.5 times the ULN
  • If a woman of child bearing potential (WOCBP), the participant has a negative serum or urine pregnancy test within 1 week prior to tagraxofusp treatment (intervals shorter than 1 week are acceptable, if required by institutional guidelines).
  • The participant has signed informed consent prior to initiation of any study-specific procedures or treatment.
  • The participant is able to adhere to the study visit schedule and other protocol requirements, including follow-up for response assessments.
  • The participant (either male or female) agrees to use acceptable contraceptive methods for the duration of time in the study, and to continue to use acceptable contraceptive methods for 2 months after the last tagraxofusp infusion.

Who cannot join

  • Participants has persistent clinically significant toxicities Grade .2 from previous chemotherapy not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue).
  • Participants has received treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of study entry.
  • Participants has received treatment with another investigational agent within 14 days of study entry or concurrent treatment with another investigational agent.
  • Participants has previously received treatment with tagraxofusp or has a known hypersensitivity to any components of the drug product.
  • Participants has an active malignancy and/or cancer history (excluding myeloproliferative disorders and concomitant myeloid malignancies as specified in the inclusion criteria) that is requiring active therapy. Participants with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ- confined prostate cancer with no evidence of progressive disease.
  • Participants has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
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  • Participants has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that, in the Investigator's opinion, would put the patient at significant risk for pulmonary complications during the study.
  • Participants has known active or suspected disease involvement of the central nervous system (CNS). If suspected due to clinical findings, CNS disease should be ruled out with relevant imaging and/or examination of cerebrospinal fluid.
  • Participants is receiving immunosuppressive therapy, with the exception of corticosteroids (maximum dose of 10 mg prednisone or equivalent) and tacrolimus for prophylaxis of graft-versus-host disease (GVHD). If the patient has been on immunosuppressive treatment for active GVHD, the treatment(s) for active GVHD must have been discontinued at least 14 days prior to study drug and there must be no evidence of Grade .2 GVHD.
  • Participants has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness that would limit compliance with study requirements.
  • Participants is pregnant or breast feeding.
  • Participants has known human immunodeficiency virus (HIV).
  • Participants has evidence of active or chronic Hepatitis B or Hepatitis C infection.
  • Participants is oxygen-dependent.
  • Participants has any medical condition that in the Investigator's opinion place the patient at an unacceptably high risk for toxicities.
  • Hydroxyurea is permitted only in settings in which a patient had been receiving this agent prior to study entry; hydroxyurea may only be administered during Cycle 1. After Cycle 1, the use of hydroxyurea may be permitted in consultation with the Principal Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

This phase I/II trial studies the side effects, best dose, and effect of tagraxofusp and decitabine in treating patients with chronic myelomonocytic leukemia. Tagraxofusp consists of human interleukin 3 (IL3) linked to a toxic agent called DT388. IL3 attaches to IL3 receptor positive cancer cells in a targeted way and delivers DT388 to kill them. Chemotherapy drugs, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tagraxofusp and decitabine may help to control the disease in patients with chronic myelomonocytic leukemia.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety, tolerability and maximum tolerable dose (MTD) of tagraxofusp-erzs (tagraxofusp) in combination with decitabine.

II. To assess overall response (OR) rate to tagraxofusp in combination with decitabine.

SECONDARY OBJECTIVES:

  1. To assess overall survival (OS), duration of response, relapse-free survival (RFS) and safety profile.

II. Correlative studies.

OUTLINE: This is a phase I, dose-escalation study of tagraxofusp-erzs followed by a phase II study.

Patients receive decitabine intravenously (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.

After completion of study treatment, patients are followed up every 3 months.

Being tested
Decitabine, Tagraxofusp-erzs
Medical subject headings
Leukemia, Myelomonocytic, Chronic, Myelodysplastic-Myeloproliferative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DecitabineDrug

    Also called 5-Aza-2''-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine

    Given IV

  • Tagraxofusp-erzsBiological

    Also called Diphtheria Toxin(388)-Interleukin-3 Fusion Protein, DT(388)-IL3 Fusion Protein, DT388IL3 fusion protein, Elzonris

    Given IV

Study groups in NCT05038592
Study groupRoleWhat they receive
Treatment (decitabine, tagraxofusp-erzs)ExperimentalPatients 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.
Receives: Drug: Decitabine; Biological: Tagraxofusp-erzs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerable dose (Phase I)

    Measured: At end of cycle 1 (1 cycle = 28 days)

  2. Incidence of dose limiting toxicities (Phase I)

    Measured: Up to end of cycle 1 (1 cycle = 28 days)

  3. Overall response (OR) (Phase II)

    Will estimate the OR for the combination treatment along with the 95% credible interval. The association between OR rate and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate.

    Measured: After 2 cycles of therapy (1 cycle = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2021
  2. Study start4 Mar 2022
  3. Primary completion29 Jan 2027 (estimated)
  4. Study completion29 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05038592
Sponsor's protocol ID
2020-0895
Other IDs
NCI-2021-04293, 2020-0895
Status last verified
Jul 2026
First submitted
1 Jun 2021
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Decitabine and Tagraxofusp-erzs in people with Chronic Myelomonocytic Leukemia and Chronic Myelomonocytic Leukemia-1, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerable dose (Phase I) (time frame: At end of cycle 1 (1 cycle = 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05038592.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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