Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802161
Status:
SUSPENDED
Last Update Posted:
2024-07-03
First Post:
2021-03-16
Brief Title:
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
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase 2 Study of Daunorubicin and Cytarabine Liposome Pomalidomide Versus Daunorubicin and Cytarabine Liposome in Newly Diagnosed AML With MDS-Related Changes
Status:
SUSPENDED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Other - Pending amendment and futility analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
PRIMARY OBJECTIVES
I To establish recommended phase 2 dose RP2D of pomalidomide after liposome-encapsulated daunorubicin-cytarabine daunorubicin and cytarabine liposome induction
II To compare the rate of overall complete response CRcomplete response with incomplete hematologic recovery CRi with daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed acute myeloid leukemia AML with preexisting myelodysplastic syndrome MDS chronic myelomonocytic leukemia CMML or myeloproliferative neoplasm MPN therapy-related AML t-AML or AML with myelodysplasia-related changes MRC based on cytogenetics or morphologic dysplasia
SECONDARY OBJECTIVES
I To evaluate and compare rates of CR full hematologic recovery between daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC
II To evaluate and compare toxicities including treatment-related mortality of daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
III To detect and compare the presence of minimal residual disease MRD by flow cytometry in those who achieve CRCRi with daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
IV To compare median event-free survival EFS of daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
V To compare median overall survival OS of daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
VI To compare median and 2-year disease-free survival DFS after CRCRi with daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
VII To compare rates of allogeneic stem cell transplant SCT after daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
EXPLORATORY OBJECTIVES
I To assess for molecular biomarkers Aiolos expression and immune correlates of response with daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
II To assess for differences in MRD by molecular based platforms in daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
OUTLINE Patients are randomized to 1 of 2 arms
ARM A
INDUCTION Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously IV over 90 minutes on days 1 3 and 5 and then pomalidomide orally PO once daily QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity Patients who do not respond may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity
CONSOLIDATION Patients who achieve CRCRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial
ARM B
INDUCTION Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously IV over 90 minutes on days 1 3 and 5 in the absence of disease progression or unacceptable toxicity Patients who do not respond may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity
CONSOLIDATION Patients who achieve CRCRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial
After completion of study treatment patients are followed up for 30 days then up to 5 years after the start of induction therapy or until death whichever occurs first
I To establish recommended phase 2 dose RP2D of pomalidomide after liposome-encapsulated daunorubicin-cytarabine daunorubicin and cytarabine liposome induction
II To compare the rate of overall complete response CRcomplete response with incomplete hematologic recovery CRi with daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed acute myeloid leukemia AML with preexisting myelodysplastic syndrome MDS chronic myelomonocytic leukemia CMML or myeloproliferative neoplasm MPN therapy-related AML t-AML or AML with myelodysplasia-related changes MRC based on cytogenetics or morphologic dysplasia
SECONDARY OBJECTIVES
I To evaluate and compare rates of CR full hematologic recovery between daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC
II To evaluate and compare toxicities including treatment-related mortality of daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
III To detect and compare the presence of minimal residual disease MRD by flow cytometry in those who achieve CRCRi with daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
IV To compare median event-free survival EFS of daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
V To compare median overall survival OS of daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
VI To compare median and 2-year disease-free survival DFS after CRCRi with daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
VII To compare rates of allogeneic stem cell transplant SCT after daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
EXPLORATORY OBJECTIVES
I To assess for molecular biomarkers Aiolos expression and immune correlates of response with daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
II To assess for differences in MRD by molecular based platforms in daunorubicin and cytarabine liposome pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS CMML or MPN t-AML or AML with MRC based on cytogenetics or morphologic dysplasia
OUTLINE Patients are randomized to 1 of 2 arms
ARM A
INDUCTION Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously IV over 90 minutes on days 1 3 and 5 and then pomalidomide orally PO once daily QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity Patients who do not respond may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity
CONSOLIDATION Patients who achieve CRCRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial
ARM B
INDUCTION Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously IV over 90 minutes on days 1 3 and 5 in the absence of disease progression or unacceptable toxicity Patients who do not respond may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity
CONSOLIDATION Patients who achieve CRCRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial
After completion of study treatment patients are followed up for 30 days then up to 5 years after the start of induction therapy or until death whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-01961 | REGISTRY | None | None |
| 10434 | OTHER | None | None |
| 10434 | OTHER | None | None |
| UM1CA186712 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186712 |