HLA Yarı-Uyumlu Akraba Verici Kök Hücre Nakli Alıcılarında T Hücresi Azaltımı

Sade dilde özet

Bu çalışma, HLA açısından yarı uyumlu (haploidentical) akraba vericilerden kök hücre nakli yapılan hastalarda T hücrelerinin azaltılması yöntemini incelemektedir. Nakil öncesi Ara-C, Cyclophosphamide, Campath-1H ilaçları ve tüm vücut ışınlaması uygulanmış; 55 yaş ve altındaki yüksek riskli lösemi, miyelodisplastik sendrom (myelodysplastic syndrome) veya benzeri kan hastalıkları olan hastalar katılabilmiştir. Baylor College of Medicine tarafından yürütülen 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

Baylor College of Medicine

Müdahale

Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation, Stem Cell Infusion

Başlangıç

01.04.2000

Tahmini bitiş

01.11.2016

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:

* Lack of 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
* Age less than or equal to 55 years of age
* Patients with high risk ALL in CR1 or ALL or high grade (stage III or IV) NHL after first relapse or with primary refractory disease or minimal residual diseases.
* Myelodysplastic syndrome
* Patients with high risk AML in CR1 or after first relapse or with primary refractory disease or minimal residual disease.
* CML
* Hemophagocytic lymphohistiocytosis (HLH), familial hemophagocytic lymphohistiocytosis (FLH), viral-associated hemophagocytic syndrome (VAHS), X-linked lymphoproliferative disease (XLP), Severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or NK-cell malignancy
* Donor cells should be collected and frozen before conditioning starts

EXCLUSION CRITERIA:

* Patients with a life expectancy (\< / = 6 weeks) limited by diseases other than leukemia
* Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction \< 25%)
* Patients with severe renal disease (i.e., creatinine clearance less than 40 cc/1.73 m\^2)
* Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of predicted)
* Patients with severe hepatic disease (direct bilirubin greater than 3 ug/dl or SGPT (serum glutamic-pyruvic transaminase) greater than 500 ug/dl)
* Patients with severe personality disorder or mental illness
* Patients with a severe infection that on evaluation by the Principal Investigator precludes ablative chemotherapy or successful transplantation
* Patients with documented HIV positivity

'High risk' ALL or AML refers to those acute leukemias identified by the presence of specific biologic features, which predict high likelihood of failure to conventional chemotherapy. As biologic features of high risk disease evolve with improvement of conventional chemotherapy, it is not practical to define this indication with any further specificity. Therefore, high risk AML/ALL will be determined by the primary physician.