Nüksetmiş/Dirençli Diffüz Büyük B Hücreli Lenfomayı Tedavi Etmek İçin R-ICE Kemoterapisine Bortezomib Eklenmesinin Uygulanabilirlik Çalışması

Sade dilde özet

Bu Faz 1 çalışması, nüksetmiş veya tedaviye dirençli diffüz büyük B hücreli lenfoma (diffuse large B-cell lymphoma) hastalarında R-ICE kemoterapisine (rituximab, ifosfamid, etoposid, karboplatin) bortezomib eklenmesinin uygulanabilirliğini incelemektedir. Çalışmaya, daha önce antrasiklin ve rituximab içeren tedavi görmüş, 21-70 yaş arası hastalar dahil edilmiştir. 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

Singapore General Hospital

Müdahale

bortezomib, rituximab, ifosphamide, etoposide, carboplatin

Başlangıç

01.11.2010

Tahmini bitiş

01.11.2014

Ülkeler

Singapore

İlgili genler

Merkezler

• Singapore, Singapore

Uygunluk kriterleri

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

Inclusion Criteria:

1. Histologically proven diffuse large B-cell lymphoma in first relapse after CR, less than PR or PR to first line treatment De Novo DLBCL, DLBCL arising from transformed follicular lymphoma or chronic lymphocytic leukaemia are allowed.

   Prior rituximab is allowed Prior radiation is allowed Prior autologous stem cell transplant is allowed CD20 negative relapses are allowed
2. Age between 21-70
3. Written informed consent
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
5. Minimum life expectancy of 3 months
6. Previously treated with chemotherapy containing anthracyclines and rituximab
7. Negative urine or serum pregnancy test on females of childbearing potential
8. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
9. Male subject agrees to use an acceptable method for contraception for the duration of the study.
10. No CNS involvement
11. Measurable disease on CT scan by international working group response criteria

Exclusion Criteria:

1. Prior allogeneic transplantation
2. Prior treatment with bortezomib
3. Concomitant use of any other anti-cancer therapy
4. Concomitant use of any other investigational agent
5. Known infection with human immunodeficiency virus (HIV)
6. Patient has known clinically active hepatitis B (carriers of hepatitis B are permitted to enter the study)
7. Contraindication to any drug contained in chemotherapy regimens
8. Not previously treated with anthracycline-containing regimens
9. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule
10. Poor bone marrow reserve (neutrophils \<1.0 x 109/L or platelets \<75 x 10(9)/L unless related to bone marrow infiltration
11. Subject has a calculated or measured creatinine clearance of \<20 mL/minute within 14 days before enrollment.
12. Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
13. Clinically significant active infection
14. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
15. Patients who are pregnant or breast-feeding
16. Coexistent second malignancy or history of prior malignancy within previous 3 years (excluding non-melanoma skin tumors or in situ carcinoma of the cervix)
17. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.