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A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
NotableLead sponsor: Children's Oncology Group to Children's Oncology GroupEnrollment increased: 1186 → 1400 participants · Study sites: 205 to 206 · Eligibility criteria expanded, about 98 words · 3 moreShow 6 more changesShow less
Enrollment increased: 1186 → 1400 participants
Study sites: 205 to 206
Eligibility criteria expanded, about 98 words
Secondary endpoints: details revised at 1 of 7 entries
Study description expanded, about 65 words
Publications: details revised at 4 of 4 entries
MinorSecondary endpoints: details revised at 1 of 7 entriesSite details revised at 6 of 205 sitesv46Show 1 more changeShow less
Minor2 versionsRe-verified since Apr 5, 2024, no change to tracked fieldsv25-v26
MinorTrial status: Recruiting to Active, Not RecruitingStudy sites: 199 to 201 · Eligibility criteria revised · Study description shortened, about 53 wordsv24Show 3 more changesShow less
MinorStudy sites: 197 to 198Start date: Jul 20, 2020 to Jul 21, 2020 · Secondary endpoints: details revised at 1 of 6 entriesv21Show 2 more changesShow less
Start date: Jul 20, 2020 to Jul 21, 2020
Secondary endpoints: details revised at 1 of 6 entries
MinorStudy sites: 195 to 197v20
MinorStudy sites: 188 to 195Interventions: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Asparaginase (Drug), Asparaginase Erwinia chrysanthemi (Drug), Cogstate… to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Asparaginase (Drug), Asparaginase Erwinia chrysanthemi (Drug), Biospecimen… · Secondary endpoints reordered · Study description shortened, about 18 wordsv19Show 3 more changesShow less
NotablePrimary and study completion dates: Feb 28, 2025 to Sep 30, 2027Study sites: 44 to 84v6Show 1 more changeShow less
Study sites: 44 to 84
MinorStudy sites: 1 to 44v5
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 1 · Start date changed from estimate of Jul 6, 2020 to Jul 20, 2020v4Show 2 more changesShow less
Study sites: 0 to 1
Start date changed from estimate of Jul 6, 2020 to Jul 20, 2020
NotableStart date: Apr 30, 2020 to Jul 6, 2020v3
MinorStart date: Apr 4, 2020 to Apr 30, 2020Interventions: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Asparaginase (Drug), Asparaginase Erwinia chrysanthemi (Drug), Cogstate… to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Asparaginase (Drug), Asparaginase Erwinia chrysanthemi (Drug), Cogstate… · Eligibility criteria expanded, about 49 words · Secondary endpoints revised (6) · 1 morev2Show 4 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, 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. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.