Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission (NCT01686334) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission
Belgium130 participantsStarted 2012-10
Plain-language summary
The primary aim of this innovative immunotherapeutic study is to determine whether the antileukemic effects seen in our previous phase I/II study can be confirmed in a large cohort of patients and whether dendritic cell vaccination can significantly prevent relapse and increase survival of acute myeloid leukemia (AML) patients by eradicating minimal residual disease.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).
* all French-American-British (FAB) subtypes, except:
\- M3 (acute promyelocytic leukemia)
* all cases of de novo AML or secondary AML with ≥ 20 % blasts in peripheral blood and/or bone marrow, except:
* AML secondary to myeloproliferative neoplasms (MPN)
* AML secondary to exposure of leukemogenic agents (t-AML) unless treated with CPX-351 chemotherapy or hypomethylating agents combined with venetoclax.
* Completion of one of the following treatment options:
* I) Intensive chemotherapy:
* (1) at least one cycle of induction chemotherapy and one cycle of consolidation chemotherapy (low-dose cytarabine as consolidation therapy is allowed) OR
* (2) one to two cycles of CPX-351 induction treatment and up to two cycles of CPX-351 consolidation treatment OR
* II) Low-intensity chemotherapy:
* (3) at least two cycles to maximum six cycles of hypomethylating agents whether or not combined with venetoclax OR
* (4) at least two cycles to maximum six cycles of low-dose cytarabine combined with venetoclax;
* resulting in:
* morphological complete remission (CR), i.e. bone marrow blast count \<5% with neutrophil count \>1000 cells/µL and platelet count \>100,000 cells/µL OR
* morphological complete remission with incomplete blood recovery (CRi), i.e. bone marrow blast count \<5% with neutrophil count \…
What they're measuring
1
Overall survival
Timeframe: At study completion, an average of 5 year