An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine, and Oxaliplatin plus Oral Enzastaurin as Treatment for Patients with Relapsed Diffuse Large B-Cell Lymphoma - N/A
- Conditions
- high-risk diffuse large B-cell lymphoma (DLBCL )MedDRA version: 8.1Level: LLTClassification code 10012822Term: Diffuse large B-cell lymphoma refractory
- Registration Number
- EUCTR2006-001985-17-FR
- Lead Sponsor
- Eli Lilly and Company limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 61
Patients may be included in the study only if they meet all of the following criteria:
[1] Histology diagnosis of DLBCL or transformed (CD20+) indolent lymphoma by the World Health Organization classification (Harris et al. 1999) at the time of relapse. In the case that histology diagnosis is not available, cytology diagnosis is accepted.
[2] Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (see Protocol Attachment S013.6; Oken et al. 1982).
[3] Have relapsed/progressed after CR, CRu or PR obtained in 1st or 2nd line treatment, or patients that have not progressed after SD obtained in 1st or 2nd line.
[4] Prior treatment with at least one anthracycline-containing regimen.
[5] Patients must have finished an interval of no less than 4 weeks from the completion of prior chemotherapy before receiving study treatment.
[6] Measurable disease according to Cheson criteria (lymph node greater than 1.5 cm in its longest transverse diameter by CT scan) (see Protocol Attachment S013.5).
[7] Estimated life expectancy of at least 12 weeks.
[8] Patient compliance and geographic proximity that allow adequate follow-up.
[9] Adequate organ function including the following:
• Hepatic: total bilirubin < or = 1.5 times upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) < or = 2.5 times ULN;
• Renal: serum creatinine <1.5 times ULN;
• Adequate bone marrow reserve: platelets =75 x 109/L, absolute neutrophil count (ANC) =1.5 x 109/L.
[10] Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 12 months after the study. Women with childbearing potential must have a negative serum pregnancy test within 3 days prior to study enrollment.
[11] Have given informed consent.
[12] =60 years or <60 (but =18 years) who are not eligible to HDC and ASCT.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients will be excluded from the study if they meet any of the following criteria:
[13] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
[14] Allogeneic transplantation. Prior autologous transplantation is allowed.
[15] More than 2 prior anti-cancer treatment regimens.
[16] Are pregnant or breastfeeding.
[17] Central nervous system (CNS) metastases (unless the patient has completed successful local treatment for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study treatment). In the absence of a clinical suspicion of brain metastases, no screening computed tomography (CT) or magnetic resonance imaging (MRI) scan before enrollment is required.
[18] Have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.
[19] Human immunodeficiency virus (HIV) associated lymphomas.
[20] Second primary malignancy (except adequately treated basal cell carcinoma of the skin). Patients who had another malignancy in the past, but have been disease-free for more than 5 years, are eligible.
[21] Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV (see Protocol Attachment S013.4).
[22] Inability to swallow tablets.
[23] Previous exposure to gemcitabine or oxaliplatin.
[24] Are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method