E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Lymphocytic Leukemia (CLL) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the overall response rate (Complete Response and Partial Response) of patients receiving chlorambucil with or without SDX-101 for the treatment of CLL. |
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E.2.2 | Secondary objectives of the trial |
•To characterize the safety and tolerability of SDX-101 when given in combination with chlorambucil, and chlorambucil alone, for the treatment of CLL. •To determine time to response, duration of response, time to progression for responders, and progression-free survival for patients receiving SDX-101 in combination with chlorambucil or chlorambucil alone. •To describe the cytogenetic profile of patients enrolled in this study and any treatment related response trends such profiles may predict. •To describe the pharmacodynamic impact of SDX-101, as monotherapy and in combination with chlorambucil, on apoptotic biologic markers in patients who have CLL.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Diagnosis of B-cell CLL by standard clinical and immunophenotypic criteria as specified by the NCI working group revised guidelines for diagnosis and treatment of CLL. 2. Binet stages A-C with evidence of active disease requiring treatment by the presence of one or more of the following at the time of study entry: •Disease related B symptoms (Fever > 38C [100.5F] for ≥ 2 weeks without evidence of infection, night sweats without evidence of infection, weight loss > 10% within previous 6 mo.). •Evidence of progressive marrow failure as manifested by: •A decrease in hemoglobin to < 10g/dL, or •A decrease in platelet count to < 100 x 10 9 /L within the previous 6 months, or •A decrease in absolute neutrophil count (ANC) to < 1.0 x 10 9/L within 6 months •Progressive lymphocytosis with an increase of > 50% over a 2 month period, or an anticipated doubling time of < 12 months. •Massive nodes or clusters(i.e., > 10 cm in longest diameter) or progressive lymphadenopathy. •Progressive splenomegaly to > 2cm below the left costal margin or other organomegaly with progressive increase over 2 consecutive clinical visits ≥ 2 weeks apart. 3.No prior chemotherapy for CLL. 4.Age ≥ 18 at signing of informed consent. 5.World Health Organization (WHO) performance status 0-2. 6.Platelet count > 50,000/μL, hemoglobin > 8.0 g/dl and absolute neutrophil count > 1000/μL. 7.Renal function ≤ 1.5 x upper limit normal (blood urea nitrogen [BUN], serum creatinine) 8.Liver function ≤ 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values). 9.Female patients of childbearing potential must have a negative pregnancy test (serum or urine beta-human chorionic gonadotropin, beta-HCG); men and women of reproductive potential must employ effective contraceptive methods while on study therapy, and for 2 months following completion of treatment. 10.Signed EC/IRB-approved informed consent by patient prior to all study related procedures.
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E.4 | Principal exclusion criteria |
1.Active autoimmune manifestation of CLL such as ongoing hemolytic anemia or ITP 2.History of a second malignancy with the exception of cervical cancer,or resected basal cell carcinoma or other malignancies with no evidence of recurrence 5 or more years since diagnosis. 3.Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV). 4.Transformation to an aggressive B-cell malignancy such as Richter’s transformation, prolymphocytic leukemia (PLL) or large B-cell lymphoma. 5.Clinical evidence of CNS involvement with CLL. 6.Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of the study objectives. 7.Treatment with any investigational agent within 4 weeks of study entry. 8.The use of steroids, nonsteriodal anti-inflammatory drugs, regardless of indication (excluding prophylactic use of aspirin for prevention of acute myocardial infarction or stroke) 9.Pregnancy or currently breast feeding
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E.5 End points |
E.5.1 | Primary end point(s) |
The overall response rate (Complete Response and Partial Response) of patients receiving chlorambucil with or without SDX-101 for the treatment of CLL. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |