DC Vaccination for Post-remission Therapy in AML

NCT02405338 | Completed Phase 1 DMC

• 1 other identifier: CD-FDC-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients. Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.

Conditions

Acute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (2)

• Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible

  2 years

• Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy

  2 years

Secondary Outcomes (6)

• Overall survival

  2 years

• Relapse/Progression free survival

  2 years

• Time to progression (TTP).

  2 years

• Control of minimal residual disease (MRD)

  2 years

• ECOG performance status

  2 years

Study Arms (1)

WT1/PRAME vaccination

EXPERIMENTAL

Biological: WT1/PRAME vaccination

Interventions

WT1/PRAME vaccination BIOLOGICAL

WT1/PRAME vaccination

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Acute Myeloid Leukemia (AML)
• Age 18 - 75 years
• Morphologic remission (CR) with or without hematological recovery (CRi) following induction chemotherapy
• WT1 with or without PRAME positivity by qPCR
• Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose
• Negative HIV 1 and 2 test, Hepatitis B and C test and negative Syphilis test at screening
• Informed consent signed prior to any trial related activities

You may not qualify if:

• Patients suitable for allogeneic stem cell transplantation
• AML M3 (acute promyelocytic leukemia)
• Patients not in complete remission (CR or CRi), bone marrow blast count ≥ 5 %
• Active immunodeficiency syndromes
• Concurrent active second malignancy other than non-melanoma skin cancers
• Clinically relevant autoimmune disease
• Prior immunotherapy
• Severe organ dysfunction precluding the apheresis procedure:
• Creatinine \> 200 mmol/l
• Bilirubin, 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
• Recent cerebral hemorrhage
• Known allergies to substances used in the generation of DCs
• Other severe acute or chronic medical psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or the administration of the investigational product

Sponsors & Collaborators

• Medigene AG: lead

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Yngvar Fløisand

  Oslo University Hospital, Rikshospitalet Department of Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 1, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: July 7, 2020

Record last verified: 2019-07

Locations

NO (1)