Remisyondaki Akut Miyeloid Lösemi Hastaları için Dendritik Hücre Aşılaması

Sade dilde özet

Bu çalışma, remisyondaki (hastalığın gerilediği dönemdeki) akut miyeloid lösemi (acute myeloid leukemia, AML) hastalarında, antijen yüklü dendritik hücrelerin enjeksiyonuyla yapılan bir aşı tedavisini incelemiştir. Çalışmaya, WHO kriterlerine göre AML tanısı olan, WT1 aşırı ifadesi bulunan ve daha önce en az bir kemoterapi almış 18 yaş ve üzeri, nüks riski yüksek hastalar katılabilmiştir. University Hospital, Antwerp tarafından yürütülen çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

University Hospital, Antwerp

Müdahale

injection of antigen-loaded cultured dendritic cells

Başlangıç

01.03.2005

Tahmini bitiş

01.12.2008

Ülkeler

Belgium

İlgili genler

Merkezler

• Edegem, Belgium

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. Tumor type: Acute Myeloid Leukemia (AML) according to the WHO criteria (ea at least 20% blasts in the marrow). All FAB subtypes except M3. Patients with Myelodysplastic Syndrome, category of Refractory Anemia with Excess Blasts (RAEB): RAEB I (WHO: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and RAEB II (WHO: medullary blast count \> 10% and/or \> 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities.
2. Extent of disease: remission (partial or complete) or smouldering course. Complete remission (CR) is defined as no blasts in the peripheral blood and no more than 5% blasts in the bone marrow. This definition is related to the hematological remission if it is not specified. Partial remission (PR) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate. Smouldering course is defined as a relatively low marrow blast count and slowly progressive disease.
3. Overexpression of WT1 RNA (\>50 copies of WT1 per 1000 copies ABL in bone marrow or \>2 copy/1000 copies ABL in peripheral blood) as assessed by quantitative RT-PCR at the time of presentation.
4. Prior treatments : Patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment and/or 6 months past allogeneic/autologous stem cell transplantation.
5. Age: ≥ 18 years
6. High risk of relapse because of (and/or)

   * Age \> 60 years (if \<60 y, no sibling allotransplant donor available)
   * Poor risk cytogenetic or molecular markers at presentation
   * Hyperleukocytosis at presentation
   * Second complete remission after relapse
7. Performance status: WHO PS grade 0-1 (Appendix B)
8. Objectively assessable parameters of life expectancy: more than 3 months
9. Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV
10. No concomitant use of immunosuppressive drugs
11. Adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
12. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
13. Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

1. Subjects with concurrent additional malignancy (with exception of Non-melanoma skin cancers and carcinoma in situ of the cervix)
2. Subjects who are pregnant
3. Subjects who have sensitivity to drugs that provide local anesthesia
4. Age \< 18 years