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Clinical picture: AML (Acute Myeloide Leukemia)

Trial: HOVON-associated DCOne-002


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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1. Overview



Summary

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


Status

open


Members

Netherlands:
Amsterdam UMC locatie VUmc, Prof. Dr. A.A. van de Loosdrecht
UMC Groningen, Prof. Dr. G. Huls


Study details



Type of study

Prospective Phase II study


Echelon level

Limited site selection


Echelon level specification

Netherlands: Amsterdam UMC, locatie VUmc; UMC Groningen. International: Germany (3 sites); Norway, Sweden, Finland.


Type of monitoring for this study

Study specific


Target number of patients

20


Date of activation

21-Dec-2017


Approved by

CCMO 11-dec-2017; Bevoegde Instantie 8-Oct-2017.
Amsterdam UMC, locatie VUmc: 21 December 2017
UMC Groningen: 11 January 2018


Study objectives

Primary:
To assess the effect of DCP-001 on MRD. MRD will be measured by flow cytometry pre and post-vaccination as a surrogate marker for established clinical endpoints in AML.
To assess the effect of DCP-001 on immune responses in AML patients in first complete remission (CR1) and persistent MRD.
To document safety and tolerability.
Secondary:
1. To identify surrogate (immunological) markers that might correlate with clinical outcome.
2. To quantify any lag time between initiation of treatment & onset of effect.
3. To determine the effect of DCP-001 on Time to Relapse (TTR).
4. To determine the effect of DCP-001 on Overall Survival (OS).
5. To document the difference between the two vaccination regimens based on MRD outcome and immunological parameters.


2. Patient eligibility criteria



Inclusion criteria

Main Inclusion Criteria:
1. Confirmed diagnosis of AML according to WHO2016 criteria, including cytological, molecular and cytogenetic criteria (except acute pro-myelocytic leukaemia/APL).
2. In CR1 (first complete remission) or CRi (incomplete blood count recovery) documented by bone marrow examination up to one month before vaccination; CR defined as less than 5% blasts in normo-cellular bone marrow, ANC >1*E9/L, platelet count >100*E9/L, no evidence of extramedullary disease. Patients in CRi (patients with <5% blasts but with incomplete blood count recovery) should have platelets >50 E9/L.
3. MRD as defined by multicolour flow cytometry (MFC) at a value of > 0.1%, or detection of specific molecular abnormalities such as NPM1 mutation.
4. Patients that are in CR1 or CRi. Patients not having undergone consolidation therapy must have been in CR1 for at least 1 month prior to enrolment.
5. Expected and willing to undergo all study procedures, including outpatient evaluations for clinical and immunological monitoring.
6. Male or female of ≥ 18 years of age.
7. Women of childbearing potential must be using anti-conceptive therapy or use two (2) barrier contraceptive methods (one by each partner and at least one of the barrier methods must include spermicide (unless spermicide is not approved in the country or region). See section 12.8 for birth control methods deemed acceptable for this study.
8. ECOG (WHO) performance status 0-2.
9. Willing and able to provide written informed consent for participation in the study


Exclusion criteria

Main Exclusion Criteria:
1. Acute Promyelocytic (APL; M3) type of AML.
2. Patients who have undergone or are scheduled for allogeneic stem cell transplantation.
3. History of previous allogeneic bone marrow or solid organ transplantation.
4. Uncontrolled or serious infections
5. Ongoing immunosuppressive therapy, other than short use of low dose steroids, i.e. equivalent to an average dose of ≤10mg of prednisone/day.
6. Chemotherapy and antineoplastic hormonal therapy within 28 days prior to the screening visits.
7. Active autoimmune disease.
8. Inadequate liver function (AST and ALT > 3 x ULN, serum bilirubin >3 x ULN).
9. Other active Malignancies 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.
10. Pregnant or lactating females.
11. 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.
12. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease.
13. Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
14. Known HIV, Hepatitis B and/or Hepatitis C infections.
15. History of hypersensitivity to the investigational medicinal product or to any excipient present in the pharmaceutical form of the investigational medicinal product.


3. Registration (& randomization) of patients



Registration

Contact one of the participating sites listed above.


4. Participating parties



5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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