E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment for B-cell Acute lymphoblastic leukemia in relapse. |
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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 assess the efficacy of lenalidomide plus low-dose dexamethasone : CR (complete response), CRp(complete response without platelet reconstitution), PR (partial response), and overall response (CR+CRp+PR) |
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E.2.2 | Secondary objectives of the trial |
• To assess the safety of lenalidomide plus dexamethasone: adverse events (type, frequency, severity of adverse events, and relationship of adverse events to study drug). • To determine the time to response. • To determine the duration of response. • To determine the progression-free survival. • To determine the QOL: European Organization for Research and Treatment of Cancer QOL questionnaire for patients with cancer (EORTC QLQ-C30). • To determine the feasibility of SCT, in case of response, after one or more cycles of lenalidomide plus dexamethasone therapy.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Documented B-cell lineage ALL (non-Ph+), which under WHO guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma. • Must have failed to at least two treatments regimens for B-lineage ALL. The inclusion of a patient can be allowed after contacting the principal investigator. Similarly, the inclusion of a patient with Ph+ ALL can be possible or must be refractory to chemotherapy. The inclusion of a patient with Ph+ All can be possible after contacting the principal investigator in presence of a T315I mutation and absence of investigational trial targeting this abnormality. • Performance status of 2 by ECOG criteria. • Any age 18 years is allowed. • Life expectancy of at least 3 months. • Adequate liver function (AST and/or ALT not > 3 times upper limits of normal). • Adequate kidney function (calculated creatinine clearance > 50 ml/min). • Signed informed consent prior to start of any study-specific procedures * Negative Pregnancy test performed in the 3 days prior to the study * Effective contraception without interruption for female subject of childbearing potential
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E.4 | Principal exclusion criteria |
• Active serious infection not controlled by oral or intravenous antibiotics. • Treatment with any investigational antileukemic agent or chemotherapy agent in at least 7 days prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy was given. • Rapidly progressive disease with compromised organ function judged to be life-threatening by the Investigator. • Patients with clinical evidence of active CNS disease. • Pregnant and/or lactating female. • Patients with known HIV infection. • Patients with known active hepatitis B and/or hepatitis C infection. • Hypersensitive or intolerant to any component of the study drug formulation.
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E.5 End points |
E.5.1 | Primary end point(s) |
Bone marrow aspirate will be performed at the end of each cycle in order to assess response to therapy and document leukemic status. Efficacy of the lenalidomide-dexamethasone combination in inducing remissions will be assessed primarily by the calculation of three response rates: CR, CRp, and RP. <response rates will be presented with 95% confidence intervals (two-tailed).
A response to treatment will be defined as the following: • CR is defined as no evidence of circulating blasts or extramedullary disease, a bone marrow with 5% blasts, and recovery of peripheral counts (platelets 100,000/mm3 and absolute neutrophil count 1000/mm3). • CRp is defined as meeting all criteria for CR except for recovery of platelet counts to 100,000/mm3. • PR is defined as complete disappearance of circulating blasts, a bone marrow with > 5% to 25% blasts, and appearance of normal progenitor cells or a bone marrow with 5% blasts that did not qualify for CR or CRp.
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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 | Information not present in EudraCT |
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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | Yes |
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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Conditions of the end of the study include the discovery of an unexpected, serious or unacceptable risk to the patients enrolled in the study. The Data and Safety monitoring board (DSMB), consisting of independent clinical oncologists will evaluate safety and efficacy data in an ongoing, periodic manner. Safety reviews will occur at scheduled intervals no less than four per year. A formal review meeting will be held following first cycle of treatment in five patients. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |