E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
previously untreated or relapsed chronic lymphocytic leukemia |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to− assess the overall response rate |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to− assess the overall response rate in biological definedrisk groups− assess the duration of response− assess the event-free survival− assess the MRD response rate |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 18 years of age or older 2. Diagnosis of B-CLL in need of treatment - Previously untreated Binet C or Binet B with need of treatment according to NCIcriteria - Relapsed or refractory disease after at least one but not more than 3 prior regimens. Patients who previously received bendamustine must have had at least a partial response with duration of response of at least six months. These patients must have completed treatment for more than six months. 3. World Health Organization performance status of 0-2 4. Life expectancy >12 weeks 5. Anti-cancer therapy, major surgery, or irradiation was completed >3 weeks before registration in this study. Patient must have recovered from the acute side effects incurred as a result of previous therapy. 6. Serum creatinine ≤1.5 the institutional upper limit of normal (ULN) or Creatinine clearance >30 ml/min/1.73 m² 7. Adequate liver function as indicated by a total bilirubin, AST, and ALT ≤2 the institutional ULN value, unless directly attributable to the patient’s tumor. 8. Female patients with childbearing potential must have a negative serum pregnancy test within two weeks of first dose of study drug(s). Male and female patients must agree to use an effective contraceptive method while on study treatment and for a minimum of six months following study therapy. 9. Signed, written informed consent. |
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E.4 | Principal exclusion criteria |
1. Previously treated with >3 prior regimens for B-CLL. 2. Known central nervous system (CNS) involvement with B-CLL. 3. Patients who have progressed with more aggressive B-cell cancers such as Richter’s syndrome. 4. History of anaphylaxis following exposure to monoclonal antibodies. 5. Known to be human immunodeficiency virus (HIV), hepatitis B, or C positive. 6. Active infection or history of severe infection (grade 4) within 3 months prior to study registration. 7. Medical condition requiring prolonged use of oral corticosteroids .. (> 1 month). 8. Use of investigational agents within 30 days prior to study randomization. 9. Active secondary malignancy.10. ANC <1.5x109/L or platelet count <75x109/L, unless due to bone marrow involvement of CLL. 11. Other severe, concurrent diseases, including tuberculosis, mental disorders, serious cardiac functional capacity (Class III or IV as defined by the New York Heart Association Classification), severe diabetes, severe hypertension, pulmonary disease (chronic obstructive pulmonary disease [COPD] with hypoxemia), or major organ malfunction (liver, kidney) that could interfere with the patient’s ability to participate in the study. 12. Pregnant or nursing women. 13. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up. 14. Participation in another clinical trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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2nd to 4th line Therapy The end of the study is defined as 3 years and 9 months after the last patient entered (unless all patients have died or withdrawn from the study before then). First line Therapy The end of the study is defined as 3 years and 9 month after the last patients entered (unless all patients have died or withdrawn from the study before then). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |