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Health Condition(s) or Problem
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Diffuse Large B-cell Lymphoma
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Lay Summary
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The purpose of this study is to compare lenalidomide to a control drug and see which one
delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).
- Relapsed or refractory to combination chemotherapy for Diffuse Large B-Cell Lymphoma
(DLBCL) that contains rituximab and an anthracycline, and one additional combination
chemotherapy or stem cell transplant.
- Measurable Diffuse Large B-Cell Lymphoma (DLBCL)disease by Computed Tomograph(CT) /
Magnetic Resonance Imagining (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Exclusion Criteria:
- Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma (DLBCL).
- History of malignancies, other than Diffuse Large B-Cell Lymphoma (DLBCL), unless the
patient has been disease free for 3 years or more.
- Eligible for autologous stem cell transplant.
- Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV)
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
- Neuropathy grade 4.
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Who cannot enter the trial
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Inclusion Criteria:
- Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).
- Relapsed or refractory to combination chemotherapy for Diffuse Large B-Cell Lymphoma
(DLBCL) that contains rituximab and an anthracycline, and one additional combination
chemotherapy or stem cell transplant.
- Measurable Diffuse Large B-Cell Lymphoma (DLBCL)disease by Computed Tomograph(CT) /
Magnetic Resonance Imagining (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Exclusion Criteria:
- Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma (DLBCL).
- History of malignancies, other than Diffuse Large B-Cell Lymphoma (DLBCL), unless the
patient has been disease free for 3 years or more.
- Eligible for autologous stem cell transplant.
- Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV)
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
- Neuropathy grade 4.
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What will happen
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Drug; Lenalidomide; Lenalidomide 25 mg orally for 21/28 days until Diffuse Large B-Cell Lymphoma (DLBCL) progressive disease. For patients with Creatinine Clearance = 30 mL/min but < 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).; Lenalidomide; Drug; Gemcitabine; Suggested starting doses and regimens for Gemcitabine is 1,250 mg/m2 IV days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m2 IV days 1 and 15 every 28 days for 6 Cycles; Investigator's Choice; Drug; Oxaliplatin; Suggested starting dose and regimen for Oxaliplatin is 100 mg/m2 IV day 1 for 21 days for 6 Cycles; Investigator's Choice; Drug; Rituximab; Suggested starting dose for Rituximab is 375 mg/m2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only); Investigator's Choice; Drug; Etoposide; Suggested starting doses for Etoposide are:
100 mg/m2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m2 oral days 1-10 every 28 days for 6 Cycles; Investigator's Choice
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Primary aim
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Stage 1: Overall response rate for Diffuse Large B-Cell Lymphoma (DLBCL) patients; Stage 2: Progression-free survival for Diffuse Large B-Cell Lymphoma (DLBCL) patients
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Secondary Aim
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Stage 2: Complete response rate for Diffuse Large B-Cell Lymphoma (DLBCL) patients; Approximately 3.5 years; No; Complete Response + Complete Response unconfirmed based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).; Stage 2: Overall response rate for Diffuse Large B-Cell Lymphoma (DLBCL) patients; Approximately 3.5 years; No; Complete Response + Complete Response unconfirmed + Partial Response based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).; Stage 2: Duration of overall response for Diffuse Large B-Cell Lymphoma (DLBCL) patients; Approximately 3.5 years; No; Length of time of overall response (Complete Response + Complete Response unconfirmed + Partial Response) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).; Stage 2: Overall survival (OS) for Diffuse Large B-Cell Lymphoma (DLBCL) patients; Approximately 3.5 years; No; Number of participants who survive; Stage 2: Duration of complete response for Diffuse Large B-Cell Lymphoma (DLBCL) patients; Approximately 3.5 years; No; Length of time of complete response (Complete Response + Complete Response unconfirmed) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).; Overall response rate for for Diffuse Large B-Cell Lymphoma (DLBCL) patients with a duration of response lasting = 16 weeks; Approximately 3.5 years; No; Complete Response + Complete Response unconfirmed + Partial Response for participants with a duration of response lasting = 16 weeks based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).; Time to progression for Diffuse Large B-Cell Lymphoma (DLBCL) patients; Approximately 3.5 years; No; Length of time until disease progression occurs; Number of Diffuse Large B-Cell Lymphoma (DLBCL) patients with adverse events; Approximately 3.5 years.; Yes; Health Related Quality of Life for Diffuse Large B-Cell Lymphoma (DLBCL) patients; Approximately 3.5 years; No; Quality of Life based on the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EQ-5D assessments
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Bournemouth, Exeter, Leeds, London, Manchester, Plymouth, Southampton, Sutton
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