DC Vaccination for Postremission Therapy in AML

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01734304
• Date of registration: 17/10/2012
• Prospective Registration: Yes
• Primary sponsor: Ludwig-Maximilians - University of Munich
• Public title: DC Vaccination for Postremission Therapy in AML
• Scientific title: Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Dendritic Cells Transfected With RNA Encoding Leukemia-associated Antigens
• Date of first enrolment: November 5, 2013
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01734304
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Germany

Contacts

• Name: Marion Subklewe, PD Dr
• Affiliation: Department of Medicine III; Hospital of the University of Munich,

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients male or female, age = 18 years, biological age = 75 years

- Patients with AML of non-favorable risk profile or with AML and sole NPM1 mutation and
confirmed increase of MRD load as detected by RQ-PCR (in two measurements at least
four weeks apart)

- CR or CRi after intensive induction chemotherapy (TAD, HAM, sHAM, 3+7 anthracycline +
cytarabine regimen, or equivalent)

- Negative HIV test, negative hepatitis B and C test

- Negative pregnancy test in women of childbearing potential

- Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

- Patients suitable for allogeneic HSCT (indication for allogeneic HSCT, adequate donor,
no contraindication for allogeneic HSCT)

- Patients with AML with favorable risk profile:

- APL (AML M3)

- inv(16), t(16;16), or del(16) as sole anomaly

- t(8;21) as sole anomaly

- biallelic CEBPA mutation as sole anomaly

- NPM1 mutation as sole anomaly, unless with confirmed increase of MRD load

- Prior allogeneic HSCT

- Anemia (Hb < 9,0 mg/dl)

- Leukopenia (< 4,0 G/l)

- Transfusion refractory thrombocytopenia (< 30 G/l platelets despite adequate number of
transfusions)

- Active clinically relevant autoimmune disease

- Active immunodeficiency syndromes

- Known allergy to GM-CSF, TNF, IFN-?, IL-4, IL-1 beta, PGE2, R848, Human AB Serum,
DMSO, HSA

- Continuous therapy with corticosteroids or other immunosuppressive drugs during the
trial

- Present substance abuse or any other factor that could limit the subject's ability to
comply with study procedures

- Severe organ dysfunction:

- Creatinine > 2,5 mg/ml

- Bilirubin > 3,0 mg/ml

- ALAT and ASAT > 3 x upper normal limit

- Respiratory insufficiency with pO2 < 60 mmHg

- Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart
failure > grade II NYHA

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study

- Simultaneous participation in another clinical trial or participation in any clinical
trial involving an investigational medicinal product within 30 days prior to written
informed consent for this trial

Exclusion criteria regarding special restrictions for females:

- Current or planned pregnancy or nursing women

- Females of childbearing potential, who are not using and not willing to use medically
reliable methods of contraception for the entire study duration and at least 3 months
thereafter (such as oral, injectable, or im-plantable contraceptives, or intrauterine
contraceptive devices) unless they are surgically sterilized/hysterectomized or there
are any other criteria considered sufficiently reliable by the investigator in
individual cases



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Myeloid Leukemia

Intervention(s)

Biological: DC vaccination for postremission therapy in AML

Primary Outcome(s)

% of grade I/II and grade III/IV toxicities [Time Frame: 30 weeks]

Secondary Outcome(s)

Control of minimal residual disease [Time Frame: 30 weeks]

Immune responses to applied antigens [Time Frame: 30 weeks]

ECOG performance status [Time Frame: 30 weeks]

Time to progression of disease [Time Frame: 30 weeks]

Secondary ID(s)

2010-022446-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors