Dendritic cells as autologous vaccine in patients with chronic myeloid leukemia

Phase 1

• Conditions: Chronic myeloid leukemia is a malignant disease of the blood. Without therapy it has an unfavourable prognosis.Under first-line therapy with newer inhibitors of the thymidinkinase some few patients only respond poorly.This condition is called minimal residual disease. The aim of this study is to investigate if a vaccinationwith autologous dendritic cells can evoke a T-cell response or even improve prognosis in the above mentionedpatients.; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2006-006962-41-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-13
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Patients with bcr/abl-positive CML in stable cytogenetic / molekular remission after at least 18 months therapy with tyrosine kinase inhibitors. The following groups of patients will be included:
a) complete cytogenetic remission (CCyR), but stable detection of bcr/abl-transkript on qPCR (at least on two different time points over a period of at least 6 months). A stable molecular remission is assumed, if the difference between the qPCR values does not exceed a factor 5 (< 0,5log).
b) No CCyR, but qPCR for bcr/abl transcript < 10% (= MCyR) after at least 24 months on 2nd generation TKI therapy.
2.Treatment with a TKI inhibitor and an additional anti leukemic drug is no exclusion criterion.
3. Patients on treatment with a-interferone can only be included, if they have already achieved a MMR
4. Age 18-80 years
5. Performance status of 0 or 1 according to WHO index or Karnofsky index >70 %
6. Life expectancy > 18 months
7. Hematological function should be at least partially conserved (plts count >50.000/ µl, Hb > 8g/dl)
8. written informed consent
9. No breast feeding
10. if of chilbearing potential, negative pregnancy test (serum/urine ß-HCG) and willingness to use highly effective contraceptive methods (Pearl Index <1, e.g.: birth control pill, loop, hormone implant, transdermal hormone patch, a combination of two barrier methods [condome and vaginal diaphragm] sterilisation or sexual abstinence) for the study duration and thereafter as long as under treatment with antileukemic drugs

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Clinically relevant autoimmune disorders
2. Immunodeficiency syndromes
3. Known allergy to GM-CSF, TNF-a , IL-4 or KLH
4. Pregnancy (absence confirmed by serum/urine ß-HCG) or breast-feeding
5. Women of childbearing age without highly effective contraception
6. Active infectious disease requiring treatment
7. Continuous therapy with corticosteroids or other immunosuppressive drugs
8. Severe psychiatric disorders
9. Organ dysfunction:
a/ Thrombin Time / Partial Thromboplastin Time > 1,5 x upper normal limit
b/ creatinine > 2,0 mg/ml
c/ Bilirubin > 3,0 mg/ml, ALAT/ASAT > 3x upper normal limit
d/ pulmonary disfunction (dyspnea at rest or with minimal exertion)
e/clinically relevant coronary heart disease or ventricular arrhythmia, congestive heart failure > grade II NYHA
10. Persons who are detained officially or legally to an official institute
11. Subjects for whom there is concern about compliance with the protocol procedures
12. Present History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) that could limit the subject’s ability to comply with study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified