Yüksek Riskli Lösemi Tedavisinde CD40 Ligand ve IL-2 ile Genetik Olarak Değiştirilmiş Tümör Aşısı

Sade dilde özet

Bu çalışma, yüksek riskli lösemi (leukemia) olan hastalarda, CD40 ligand ve IL-2 ile genetik olarak değiştirilmiş bir tümör aşısını incelemiştir. Çalışmaya, 75 yaş ve altında, lenfoid veya akut miyeloid lösemi ya da miyelodisplastik sendrom tanısı olan ve nüks açısından yüksek riskli hastalar katılabilmiştir. 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

Baylor College of Medicine

Müdahale

Dose Level 1, Dose Level 2, Dose Level 3

Başlangıç

01.06.1999

Tahmini bitiş

01.06.2010

Ülkeler

United States

İlgili genler

Merkezler

• Houston, United States
• 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:

1. Patients less than or equal to 75 years old with lymphoid (pre-B, B, T, non B-, non T, or Burkitt if bone marrow blasts \> 20%) or acute myeloid leukemia (M0 to M7) or myelodysplastic syndrome and with: Disease that has entered remission with chemotherapy and/or bone marrow transplantation, but is considered to be at high risk of relapse. or Primary, or relapsed treatment-refractory disease who, at the time of reinjection of the tumor vaccine, are at a state of complete or partial cytological remission disease (\<20% blasts infiltrating the bone marrow) after a second/higher line of conventional and/or high dose chemotherapy.
2. Patients must have a life expectancy of at least 10 weeks.
3. Patients must have ECOG performance status of 0-2 as below:
4. Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and have an absolute neutrophil count \>500/mm3, absolute lymphocyte count \>200/mm3, and platelet count \>50,000/mm3.
5. Patients must not have active GvHD at the time of protocol entry.
6. Patient has not received high dose steroids within the last week or other immunosuppressive drugs within a week (or longer as indicated by the half life of the agent)
7. Patients must not be infected at time of protocol entry, and should not be receiving antibiotics (other than prophylactic Septra.)
8. Patients must not be HIV-positive.
9. Patients must have adequate liver function (bilirubin\<1.5 mg% SGOT\<2x normal, normal prothrombin time).
10. Patients must have transduced cells available that are demonstrably \>20% CD40L expressing fibroblasts and producing\>150 pg IL-2/10 6 cell/24 hr.
11. Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
12. Patient must not have received treatment with other investigational agents within the last 4 weeks.
13. Patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.

Exclusion Criteria:

1. Rapidly progressive/refractory disease (\>20% blasts infiltrating the bone marrow)
2. Life expectancy \< 10 weeks
3. Active infection
4. Need for concomitant drugs except analgesics
5. Pregnancy or lactation
6. Seropositive for HIV