Miyeloid Lösemi ve Miyelom için Dendritik Hücre Tedavisinin Etkinliği

Sade dilde özet

Bu çalışma, dendritik hücre aşısı (bir tür bağışıklık tedavisi) uygulamasının etkinliğini kan kanserlerinde inceliyor. Çalışmaya, akut miyeloid lösemi (acute myeloid leukemia), kronik miyeloid lösemi (chronic myeloid leukemia) veya multipl miyelom (multiple myeloma) tanısı olan 18 yaş ve üzeri hastalar alınmıştır. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Zwi Berneman

Müdahale

dendritic cell vaccination (active specific immunotherapy)

Başlangıç

01.01.2010

Tahmini bitiş

07.03.2019

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:

* Acute Myeloid Leukemia (AML): all FAB subtypes except M3. Extent of disease:

  * clinical remission after at least one course of polychemotherapy
  * high risk of relapse due to age (\> 60 years) or poor risk cytogenetic/molecular markers or hyperleukocytosis at presentation or previous relapse
* Chronic myeloid leukemia (CML): patients in chronic phase under therapy with tyrosinase kinase inhibitors who have sub-optimal response or failure and who are not eligible for hematopoietic stem cell transplantation.
* Multiple Myeloma (MM): symptomatic with active disease, independent of earlier and/or concomitant treatment:

  * Presence of serum/urine M protein (\> 3 g/dl)
  * Bone marrow plasmacytosis (\>10-30%)
  * Anemia, renal failure, hypercalcemia, and/or lytic bone lesions
* Overexpression of WT1 RNA in peripheral blood and or bone marrow as assessed by quantitative RT-PCR at the time of presentation.For CML: residual molecular disease as demonstrated by BCR-ABL RT-PCR
* Prior treatments: Patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment.
* Age: ≥ 18 years
* Performance status: WHO PS grade 0-1 (Appendix B)
* Objectively assessable parameters of life expectancy: more than 3 months
* Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV
* No concomitant use of immunosuppressive drugs
* adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
* 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
* Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

* Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)
* Subjects who are pregnant
* Subjects who have sensitivity to drugs that provide local anesthesia
* Subjects needing corticosteroids 1 mg/kg during vaccination; corticosteroids are allowed as part of their treatment when taken ≥ 30 days before the start of vaccination.