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 |
The principal objective is to find a method for predicting at the earliest time possible (after receiving only one cycle of chemotherapy) if chemotherapy will work in patients with Hodgkin Lymphoma receiving ChlVPP chemotherapy This study will assess and compare the ability of FDG-PET/CT and FLT-PET/CT imaging in predicting, after only one cycle of treatment, the response of patients to the chemotherapy being administered. This is possible by comparing changes in tumour uptake of glucose by using FDG-PET/CT scans done before treatment, after one cycle and at completion of chemotherapy treatment. Also by assessing changes in tumour cell division by using FLT-PET/CT scans done before treatment, after one cycle and at completion of chemotherapy treatment. The working hypothesis is that it would be possible to use the changes recorded by each modality to predict individual patient response early during treatment and to test whether FLT is better than FDG at predicting this respons |
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E.2.2 | Secondary objectives of the trial |
1)To establish criteria for prediction of treatment response using images obtained using FLT-PET/CT during treatment of patients. 2)To establish criteria for prediction of treatment response using images obtained using FDG-PET/CT uptake during treatment of patients. 3)To study the predictive information of FDG and FLT uptake in Hodgkin Lymphoma for treatment response: a)At baseline. b)After the first cycle of chemotherapy. c)At the end of treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Males and Females; aged > 18 years (no upper limit) 2.Histological diagnosis of Hodgkin Lymphoma(HL) according to WHO lymphoma classification. 3.Receiving ChlVPP chemotherapy. 4.Performance status (ECOG) 0-2. 5.Able and willing to give written informed consent and to comply with the study protocol procedures |
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E.4 | Principal exclusion criteria |
1.Primary Central Nervous System (CNS) lymphoma. 2.Contraindication to any of the drugs contained in the chemotherapy regimen. 3.Previous or concurrent malignant disease unless basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix or the patient has been disease-free for more than 2 years. 4.Any other serious active disease that in the opinion of the investigator might preclude the patient from having conventional chemotherapy. 5.Females of child bearing potential must have a negative pregnancy test prior to starting the study. Females must not be pregnant or lactating Females of child bearing potential and all males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study and for up to 3 months after the last FDG-PET/CT and FLT-PET/CT scans. Note: subjects are not considered of childbearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal 6.Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1)Changes in tumour FDG uptake from baseline PET/CT (FDG-PET/CT-1) to PET/CT after the first cycle of immunochemotherapy (FDG-PET/CT-2) compared to response after completion of treatment (FDG-PET/CT-3). 2)Changes in tumour FLT uptake between baseline (FLT-PET/CT-1) and after the first cycle of immunochemotherapy (FLT-PET/CT-2) compared to response after completion of treatment (FDG-PET/CT-3). 3)Response assessed by FLT-PET/CT after completion of treatment (FLT-PET/CT-3) compared to FDG-PET/CT after completion of treatment before HDT (FDG-PET/CT-3) |
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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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Monitoring of treatment by PET/CT |
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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 | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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 end of the trial is defined as the last patient last visit |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |