Status:
COMPLETED
Feasibility Study Of Adding Bortezomib to R-ICE Chemotherapy To Treat Relapsed/ Refractory Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
Incorporation of rituximab to conventional chemotherapy (R-CHOP) has revolutionalized the frontline treatment of diffuse large B-cell lymphoma (DLBCL), one of the commonest subtype of lymphoma. Althou...
Detailed Description
The most commonly used regimen for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) is the R-ICE regime (rituximab, ifosphamide, cisplatin and etoposide). It was previously reported to give a...
Eligibility Criteria
Inclusion
- 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
- Age between 21-70
- Written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Minimum life expectancy of 3 months
- Previously treated with chemotherapy containing anthracyclines and rituximab
- Negative urine or serum pregnancy test on females of childbearing potential
- 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.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- No CNS involvement
- Measurable disease on CT scan by international working group response criteria
Exclusion
- Prior allogeneic transplantation
- Prior treatment with bortezomib
- Concomitant use of any other anti-cancer therapy
- Concomitant use of any other investigational agent
- Known infection with human immunodeficiency virus (HIV)
- Patient has known clinically active hepatitis B (carriers of hepatitis B are permitted to enter the study)
- Contraindication to any drug contained in chemotherapy regimens
- Not previously treated with anthracycline-containing regimens
- Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule
- Poor bone marrow reserve (neutrophils \<1.0 x 109/L or platelets \<75 x 10(9)/L unless related to bone marrow infiltration
- Subject has a calculated or measured creatinine clearance of \<20 mL/minute within 14 days before enrollment.
- 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.
- Clinically significant active infection
- Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
- Patients who are pregnant or breast-feeding
- Coexistent second malignancy or history of prior malignancy within previous 3 years (excluding non-melanoma skin tumors or in situ carcinoma of the cervix)
- Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01226849
Start Date
November 1 2010
End Date
November 1 2014
Last Update
April 27 2017
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608