E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
We plan to assess the amount of [18F]ML-10 that is taken up by cancer cells undergoing programmed cell death or apoptosis. We will assess this after chemotherapy treatment in patients with Non Hodgkin's lymphoma, using positron emission tomography (PET) scanning.
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E.2.2 | Secondary objectives of the trial |
The secondary research question is to explore if we can relate the extent of [18F]ML-10 uptake in patients non Hodgkin’s lymphoma following a cycle of chemotherapy with response to treatment. Response to treatment will be assessed from shrinkage of tumour and/or the changes in tumour metabolism as observed from routine CT or PET scans performed during treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects must be capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form. 2. Male or female subjects >18 years of age at screening with histological or cytological diagnosis of non Hodgkin’s lymphoma and due to receive intravenous chemotherapy for the first time, with indolent (e.g. follicular) and aggressive (e.g. diffuse large B cell, mantle cell lymphomas), prior to the initiation of the first cycle of chemotherapy and having target lesion about 2 cm in diameter in one dimension or more. 3. A female subject is eligible to participate if she is of non-childbearing potential. If the female subject is of childbearing potential, she must agree to use one of the protocol-specified contraception methods. All females of child-bearing potential will have urine pregnancy test before the PET scanning procedure. The result of the pregnancy test must be negative. 4. A male subject must agree to use one of the protocol-specified contraception methods. 5. Subjects must be able to lie comfortably on back for up to 70 minutes at a time. 6. Subjects must have a WHO performance status of 0, 1 or 2. |
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E.4 | Principal exclusion criteria |
1. The subject has a known history of Hepatitis B, Hepatitis C, non-A, non-B or human immunodeficiency virus (HIV). 2. Any clinical significant medical conditions that in the opinion of the investigator would compromise the subject's compliance with study procedures. 3. Pregnant or breast feeding females. 4. The subject has received any other prior anticancer therapy (radiotherapy, chemotherapy, or immunotherapy). Prior radiotherapy to metastatic lesion(s) is permitted, provided there is at least one PET imageable lesion that has not been irradiated. 5. The subject has received any new investigational agent, including an investigational anti-cancer agent. 6. The subject has a history of sensitivity to heparin or heparin-induced thrombocytopenia. 7. Males and female subjects not able to comply with contraceptive guidelines during the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Extent of increased [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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 | 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) | 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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | No |
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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The trial will be considered to be complete on the collection of the last subject's standard of care imaging scans following completion of all cycles of chemotherapy. This will occur some time after the last study visit of this subject but is required in order to collect data on the outcome of the chemotherapy. This will enable a comparison between this data and the data provided by the [18F]ML-10 PET/CT scan. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |