Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia

NCT01373515 | Completed Phase 1 DMC

• 1 other identifier: DCOne-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label phase 1 feasibility and safety dose escalation study. The main objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML.

Conditions

Acute Myeloid Leukemia (AML); Leukemic Dendritic Cell Vaccination

Keywords

DCOne; DCP-001; Second complete remission of AML; Relapse AML

Outcome Measures

Primary Outcomes (1)

• Safety/Feasibility of DCP-001 vaccination

  The primary endpoint of this study will be the safety and feasibility of DCP-001 vaccination in AML patients. Safety will be assessed by means of laboratory evalulations, lhysical examination, vital sign assessments and adverse events recording. Clinical efficacy is assessed by the presence of leukemic cells in blood and bonemarrow and physical examination at baseline, during and after vaccination

  three months and follow up after study completion

Secondary Outcomes (1)

• Immunological responses induced by DCP-001 vaccination

  3 months

Study Arms (4)

Cohort 1; 1x10E7 DCP-001

EXPERIMENTAL

n=3; patients receiving 4 bi-weekly vaccinations of 1x10E7 DCP-001.

Biological: DCP-001

Cohort 2; 2.5x10E7 DCP-001

EXPERIMENTAL

n=3; patients receiving 4 bi-weekly vaccinations of 2.5x10E7 DCP-001.

Biological: DCP-001

Cohort 3; 5x10E7 DCP-001

EXPERIMENTAL

n=3; patients receiving 4 bi-weekly vaccinations of 5x10E7 DCP-001.

Biological: DCP-001

Cohort 4; 5x10E7 DCP-001

EXPERIMENTAL

n=3; patients, matched for HLA-A2, receiving 4 bi-weekly vaccinations of 5x10E7 DCP-001. Or, in case this turned out toxic, this group will receive the Maximum Tolerated Dose.

Biological: DCP-001

Interventions

DCP-001 BIOLOGICAL

4 bi-weekly vaccinations

Cohort 1; 1x10E7 DCP-001; Cohort 2; 2.5x10E7 DCP-001; Cohort 3; 5x10E7 DCP-001; Cohort 4; 5x10E7 DCP-001

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with AML, in second complete remission of AML (all FAB-subclasses), not eligible for additional intensification therapies e.g. allogeneic (allo) PSCT \[independent of age\]; OR
• Patients with relapse (smouldering) AML not eligible for additional intensification therapies e.g. alloPSCT; OR
• Patients with de novo (smouldering) AML not eligible for intensive treatment according to current HOVON trials.
• Patients \>65 years of age with de novo AML in first CR and off protocol of current HOVON trials.
• WHO performance of 0, 1, or 2.
• Male or female patients at least 18 years of age and \<80 years by date of enrolment.
• Patients not treated within current HOVON or other AML trials.
• Ability and willingness to give informed consent.
• HLA-A2.1 positive patients (only for cohort 4).

You may not qualify if:

• Uncontrolled active infection.
• Previous immunotherapy in last 3 months (except for anti-CD33 targeted therapy).
• Previous allogeneic PSCT.
• Inadequate bone marrow function: absolute neutrophile count (ANC) \< 0.5x10E9/L, or platelet count \< 20x10E9/L or active bleeding with platelet count \> 20x10E9/L.
• Inadequate liver function, defined as:
• Serum (total) bilirubin \> 1.5 x the upper limit of normal (ULN)
• AST/SGOT or ALT/SGPT \> 2.5 x ULN
• Alkaline phosphatase levels \> 2.5 times the ULN at baseline.
• Inadequate renal function, defined as:
• Serum creatinine \> 1.5 x ULN
• Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
• Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.
• Women of childbearing potential (defined as \< 2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly).
• Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
• Minor surgical procedures, within 24 hours prior to the first study treatment.

Sponsors & Collaborators

• Mendus: lead

Study Sites (1)

VU University Medical Center

Amsterdam, Netherlands

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 Design

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

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 15, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

NL (1)