Dendritic cell-based immunotherapy targeting the tumor protein WT1 to treat adult patients with acute myeloid leukemia

Phase 1

• Conditions: Adult patients with acute myeloid leukemia in complete remission; MedDRA version: 20.0Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 100000004865; MedDRA version: 20.1Level: LLTClassification code 10024329Term: LeukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001494-91-BE
• Lead Sponsor: Antwerp University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).

o all French-American-British (FAB) subtypes, except:
- M3 (acute promyelocytic leukemia)

o 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 (HMA) whether or not combined with venetoclax (VEN) (hereafter referred as HMA+/- VEN) OR
(4) at least two cycles to maximum six cycles of low-dose cytarabine (LDAC) combined with venetoclax (hereafter referred as LDAC+VEN);

resulting in:

o 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
o morphological complete remission with incomplete blood recovery (CRi), i.e. bone marrow blast count <5% with neutrophil count <1000 cells/µL or platelet count <100,000 cells/µL.
For the purpose of this study protocol, platelet count must be >50,000 cells/µL.

• Adult (= 18 years) at very high risk of relapse according to:
oAge = 60 years, and/or
oAdverse biological features (e.g. adverse cytogenetics, adverse morphological features, adverse molecular features, hyperleukocytosis (> 100000 cells/µL)), and
oIneligible for or unwilling to receive hematopoietic stem cell transplantation.

• WHO performance status: grade 0, 1 or 2 at the time of enrollment.
For definition of performance status, see: http://www.ecog.org/general/perf_stat.html

• Absence of any psychological, familial, sociological, geographical or physical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before study entry.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

• Participation in any other interventional clinical trial during the study period.

• History or concomitant presence of any other malignancy, except for:

o non-melanoma skin cancer
o carcinoma in situ of the cervix
o any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment.

• Concomitant presence of any immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo.

• Concomitant use of systemic corticosteroids in immunosuppressive doses (>1 mg/kg/day of prednisone, or equivalent dose for other corticosteroid preparations) or any other immunosuppressive agent. A minimum of 4 weeks must have elapsed between the last dose of immunosuppressive therapy and the first vaccination. Topical corticosteroids are permitted, except if applied at the sites of DC injection.

• pregnancy or breast-feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified