An open-label study to evaluate the utility of the apoptosis imaging biomarker [18F]ML-10 to assess the response to chemotherapy in patients with non Hodgkin's lymphoma. - Utility of ML10-PET imaging for Apoptosis Evaluation

• Conditions: on Hodgkin’s lymphoma

• Registration Number: EUCTR2010-019832-11-GB
• Lead Sponsor: GlaxoSmithKline Research and Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-11
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.<br><br>;Secondary Objective: 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. ;Primary end point(s): Extent of increased [18F]ML10 uptake in tumours following chemotherapy using<br>visual and semi-quantitative parameters.