Kaspaz-9 İntihar Geni Taşıyan Donör T Hücrelerinin Uygulanması

Sade dilde özet

Bu çalışma, uygun geleneksel donörü bulunmayan ya da hastalığı hızlı ilerleyen hastalarda, kaspaz-9 intihar geniyle donatılmış donör T hücrelerinin verilmesini incelemektedir. Hücreler graft-versus-host hastalığına yol açarsa AP1903 adlı ilaçla yok edilebilmektedir. Faz 1 aşamasında yürütülmekte; devam ediyor ancak yeni katılımcı almamaktadır.

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

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Devam ediyor, katılım kapalı

Sponsor

Baylor College of Medicine

Müdahale

iCaspase9-transduced T cells, AP1903

Başlangıç

01.11.2011

Tahmini bitiş

01.05.2029

Ülkeler

United States

İlgili genler

Merkezler

• Houston, United States
• Houston, United States

Uygunluk kriterleri

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

Inclusion Criteria:

Inclusion Criteria at Time of Procurement:

1. Lack of a suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor), or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
2. High risk disease in one of the following:

   * Myelodysplastic syndrome (MDS) in one of the following categories: RCMD with an IPSS-R of intermediate, poor, or very poor, RAEB-1, or RAEB-2
   * Acute myeloid leukemia (AML) after first relapse or primary refractory disease
   * Chronic myelogenous leukemia (CML) in Chronic Phase 2 or greater, Accelerated Phase or Blast Crisis
   * Acute lymphoblastic leukemia (ALL) after first relapse or primary refractory disease, or High-Grade Non Hodgkin lymphoma (NHL) Stage III or IV after first relapse or primary refractory disease
   * Hemophagocytic lymphohistiocytosis (HLH)
   * Familial hemophagocytic lymphohistiocytosis (FLH)
   * Viral-associated hemophagocytic syndrome (VAHS)
   * T or NK cell lymphoproliferative syndrome
   * X-linked lymphoproliferative disease (XLP)

Inclusion Criteria at Time of T Cell Infusion:

1. Engrafted with an absolute neutrophil count (ANC) \> 500 cells/µL
2. Greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease
3. Life expectancy \> 30 days
4. Lansky/Karnofsky score greater than or equal to 60
5. Absence of severe renal disease (creatinine \> 2X upper limit of normal for age)
6. Absence of severe hepatic disease (direct bilirubin \> 3X upper limit of normal or SGOT \> 3X upper limit of normal)
7. Oxygen saturation \> 94% on room air
8. Patient/Guardian able to give informed consent
9. AP1903 available in sufficient quantities to allow for treatment of the patient

Exclusion Criteria:

Exclusion Criteria at Time of T Cell Infusion:

1. GvHD
2. Severe intercurrent infection
3. Pregnancy\*
4. Other investigational drugs in the prior 30 days

   * Pregnancy test only required for at-risk individuals, defined as female patients of childbearing potential who have received a reduced-intensity conditioning regimen.