Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes

Running, not enrolling · Phase 2

Conditions studied: Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Acute Myeloid Leukemia With Multilineage Dysplasia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm

In brief

This phase II trial studies the effect of adding pomalidomide to usual chemotherapy treatment (daunorubicin and cytarabine liposome) in treating patients with newly diagnosed acute leukemia with myelodysplastic syndrome-related changes. Pomalidomide may stop the growth of blood vessels, stimulate the immune system, and kill cancer cells. Chemotherapy drugs, such as daunorubicin and cytarabine liposome, 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. Adding pomalidomide to chemotherapy treatment with daunorubicin and cytarabine liposome may be effective in improving some treatment outcomes in patients with newly diagnosed acute leukemia with myelodysplastic syndrome-related changes.

Key facts

Study ID

NCT04802161

Run by

National Cancer Institute (NCI)

People needed

49

Starts

2022-08-24

Expected to finish

2027-04-25

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathological confirmation of AML as defined by histologic, morphologic, or cytological evidence/confirmation of >= 20% blasts in bone marrow aspirate and/or biopsy
• Must meet criteria for t-AML or AML with MRC as defined by the 5th Edition of the World Health Organization (WHO) Classification of Myeloid Neoplasms or the International Consensus Classification (ICC) of Myeloid Neoplasms. Patients must meet one of the following criteria:
• Therapy-related AML (AML derived from prior chemotherapy or radiation therapy)
• AML originating from prior hematologic malignancy (MDS, CMML, or MPN)
• AML with myelodysplasia-related cytogenetic abnormalities:
• One of the following cytogenetic abnormalities:
• Complex karyotype (3 or more unrelated chromosomal abnormalities in the absence of other class-defining recurrent genetic abnormalities as defined by WHO or ICC)
• -7/del(7q)
• Del(5q)/t(5q)/add(5q)
• +8
• i(17q)
• -17/add(17p) or del(17p)
• Del(20q)
• -13/del(13q)
• Del(11q)
• Del(12p)/t(12p)/add(12p)
• idicX(q13)
• AML with myelodysplasia-related mutations: Must have a mutation in one of the following genes:
• ASXL1
• BCOR
• EZH2
• RUNX1
• SF3B1
• SRSF2
• STAG2

You may not qualify if…

• Patients with Wilson's Disease or Copper-related metabolic disorders
• Absolute blast count > 30 x 10\^9/L (cytoreduction with leukapheresis or hydroxyurea can be used to achieve absolute blast count < 30 x 10\^9/L prior to day 1 of treatment)
• Cumulative daunorubicin lifetime exposure > 330 mg/m\^2 and > 180 mg/m\^2 with prior mediastinal radiation therapy
• Patients with known active central nervous system leukemia should be excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients receiving intrathecal chemotherapy prophylaxis should receive pomalidomide >= 3 days after administration
• Patients with uncontrolled intercurrent illness including, but not limited to, active and uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia. Patients with infection under active treatment and controlled with antibiotics are eligible
• Known additional malignancy (with the exception of prior hematologic malignancies that have transformed to AML) that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical cancer or patients receiving maintenance treatments without active disease (for example, hormonal therapy for breast cancer or prostate cancer or other adjuvant chemotherapy approaches). Anti-cancer therapy as above should be discontinued > 72 hours prior to day 1 of treatment
• Patients with psychiatric illness/social situations that would limit compliance with study requirements
• Receipt of prior allogeneic stem cell transplant
• Administration of any therapy for MDS, CMML, or MPN (conventional or unconventional) must be completed by 2 weeks prior to treatment with daunorubicin and cytarabine liposome. Use of strong CYP1A2 inhibitors should be avoided
• Patients who are receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide (e.g. lenalidomide, thalidomide) or daunorubicin and cytarabine liposome or their excipients
• Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide, or similar drugs in the past
• Pregnant women are excluded from this study because pomalidomide is an immunomodulatory agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pomalidomide, breastfeeding should be discontinued if the mother is treated with pomalidomide. These potential risks may also apply to other agents used in this study. Women of childbearing potential must be willing to undergo pregnancy testing
• Any other medical condition that in the opinion of investigator would place patient at increased risk for toxicity during pomalidomide treatment (i.e. history of recurrent or serious thromboembolic events such as massive pulmonary embolism)

Where it is running

• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
• University of Kansas Cancer Center — Kansas City, Kansas, United States
• University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• NYP/Weill Cornell Medical Center — New York, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• University of Cincinnati Cancer Center-West Chester — West Chester, Ohio, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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