Kan Kanseri Olan HIV Pozitif Hastalarda Genetik Olarak Değiştirilmiş Kemik İliği Kök Hücre Nakli

Sade dilde özet

Bu çalışma, HIV pozitif olduğu için normalde nakil adayı sayılmayan kan kanseri hastalarında, retroviral vektörle genetik olarak değiştirilmiş donör kök hücrelerinin nakledilmesini incelemiştir. Amaç, hem kan kanserini tedavi etmek hem de nakledilen hücrelere HIV'e karşı direnç kazandırmaktı. 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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Müdahale

GCSF Mobilized Allogeneic PBSC Cultured w/Cytokines; Transduced w/RV

Başlangıç

01.09.1999

Tahmini bitiş

01.11.2001

Ülkeler

United States

İlgili genler

Merkezler

• Bethesda, United States

Uygunluk kriterleri

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

PATIENTS:

Patients with hematologic malignancies curable by allogeneic BMT not currently considered for transplant because of HIV positivity.

Chronic myelogenous leukemia (CML): chronic phase.

Acute lymphoblastic leukemia (ALL), all patients in complete or partial remission.

Acute myelogenous leukemia (AML): AML in first complete or partial remission. (Exceptions: AML with good risk karyotypes: AML M3t, AML M4Eo, AML t. All AML in second or subsequent complete remission.)

Myelodysplastic syndromes: refractory anemia (failing ATG and/or CSA) to early transformation to acute leukemia. Chronic myelomonocytic leukemia and myeloproliferative disease.

Chronic lymphocytic leukemia (CLL) and prolymphocytic leukemia, in complete or partial remission, Mantle cell lymphoma, relapsed Hodgkin's and non-Hodgkin's lymphoma.

Multiple myeloma in remission following chemotherapy.

No major organ dysfunction precluding transplantation.

DLCO greater than 40 percent predicted.

Left ventricular ejection fraction greater than 30 percent.

ECOG performance status of 0 to 2.

DONOR:

HLA identical sibling donor.

Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke, no history of severe heart disease).

Informed consent given.

DONOR AND PATIENT:

Must not be pregnant or lactating.

Must be between 18 and 80 years of age.

Must not have ECOG performance status of 3 or more. Must not have psychiatric disorder or mental deficiency of the patient or the donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.

Must not have a major anticipated illness or organ failure incompatible with survival from BMT as determined by your NIH physician (including encephalopathy, cardiomyopathy, and hepatitis.)

Must not have DLCO less than 40 percent predicted.

Must not have glomerular filtration rate less than 40.

Must not have serum bilirubin greater than 4 mg/dl, transaminases greater than 4x upper limit of normal.

Donor must be HIV negative. Donors who are positive for HBV, HCV or HTLV will be used at the discretion of the investigator.

Must not have other malignant diseases liable to relapse or progress within 5 years.

Donor must be fit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of congestive heart failure or unstable angina, thrombocytopenia).