Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

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

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

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

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.

DCP-001

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.

DCPrime is testing an allogeneic (non-self cells, standardised product) DC-based immunotherapy in cancer patients. The technology consists of sustainable dendritic progenitor cells (named "DCOne™") and a proprietary method to expand these and to create functional mature dendritic cells (DCP-001).

AML is a fast growing form of leukemia that particularly in the elderly (\>60) is life threatening. As age is an important factor in determining the success of AML treatment, overall, AML has a bad prognosis as only 24% of the patients are alive 5 years after diagnosis.

Without treatment AML is fatal, usually within months. Chemotherapy can cure patients and prolong survival in responders; however, chemotherapy is also quite toxic and can cause substantial morbidity and mortality. The most commonly prescribed first line therapy for patients with AML is a combination of an anthracycline and cytarabine; in the Western world the anthracycline is either daunorubicin or idarubicin. Post remission therapy (consolidation therapy) is usually given.

There is therefore substantial medical need for new treatment modalities. One of the major difficulties regarding development of new agents is that relatively low response rates and toxicity issues have been in the way of approval of new agents. Immunotherapy, in particular with the therapeutic vaccines, is expected to have potential in prevention of recurrence of disease after cytoreductive therapy. Any drug that could prevent or reduce minimal residual disease in the population is likely to meet a strong medical need for this population of high risk patients.

In this phase 1 trial consecutive eligible patients will be treated until 12 patients have completed the study. Patients will be started with the vaccination program within 2 months after having achieved complete remission or in patients who have stable disease over at least a 2 month period.

The first cohort (n=3) will receive 4 bi-weekly vaccinations of 1x10E7 DCP-001, the second cohort (n=3) will receive 4 bi-weekly vaccinations of 2.5x10E7 DCP-001, and the last cohort (n=3) will receive 4 bi-weekly vaccinations of 5x10E7 DCP-001. The Dose Limiting Toxicity (DTL) is defined as non-hematological toxicity of ≥ 3 according to common toxicity criteria v3.0. The 4th cohort (matched for HLA-A2) will receive 4 vaccinations of the highest dose (5x10E7 DCP-001) or, in case this turned out to be toxic (as determined by the vaccination profile of cohort 1, 2 and 3), this group will receive the Maximum Tolerated Dose (MTD).

DCP-001 vaccine is presented as a direct injectable sterile cell suspension consisting of irradiated mature dendritic cells in cryopreservation solution packed in vials. The vaccine will be administered intradermally.

Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia

Phase 1 Study of Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia

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

The secondary endpoint of this study will be establishment of immunological responses induced by DCP-001 vaccination.

Mendus

Symptoms and General Pathology

Neoplasm, Residual

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

patients receiving 4 bi-weekly vaccinations with 25E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination

patients receiving 4 bi-weekly vaccinations with 50E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination

A A van de Loosdrecht, MD, PhD

Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD

International, multicentre, open-label proof of concept study exploring two different dose groups of the allogeneic dendritic cell vaccine, DCP-001. Cohort 1 consists of 10 patients that will receive 25E6 DCP-001 cells per vaccination and Cohort 2 consists of 10 patients who will receive 50E6 DCP-001 cells per vaccination. All patients will be given two additional booster vaccinations of 10E6 cells. Each patient will be followed up for 12 months after the 4th vaccination. Safety will be monitored throughout the study. Sera and cell samples (blood and bone marrow) will be collected for assessment of efficacy (MRD evaluation) and immune response monitoring.

First 10 patients will get the lowest dose and next 10 patients will receive the highest dose

Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia

An International, Multicentre, Open-label Study To Evaluate The Efficacy and Safety of Two Different Vaccination Regimens of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia That Are In Remission With Persistent MRD

Any change in MRD (flow cytometric) as compared to baseline MRD

Any change in immunoreactivity (specific and non-specific) as compared to baseline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia	NCT01373515	Acute Myeloid L... Leukemic Dendri...	DCP-001	18 Years - 80 Years	Mendus
Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia	NCT03697707	Acute Myeloid L...	DCP-001	18 Years -	Mendus

Spots Global Cancer Trial Database for dcone

Every month we try and update this database with for dcone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dcone

Every month we try and update this database with for dcone cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dcone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.