Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment … (NCT04802161) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
United States50 participantsStarted 2022-08-24
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* U2AF1
* ZRSR2
* No prior treatment for AML other than cytoreductive doses of hydroxyurea or leukapheresis
* Age \>= 18 and =\< 75 years on day of signing informed consent are eligibl…
What they're measuring
1
Rate of Complete Response (CR)/Complete Response With Incomplete Hematologic Recovery (CRi)