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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Guy Pratt


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Be Part of Research - Trial Details - Efficacy and safety of olaparib in relapsed and refractory chronic lymphocytic leukaemia patients with an 11q deletion or ATM mutation and relapsed/refractory patients with T-prolymphocytic leukaemia and mantle cell lymphoma
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Efficacy and safety of olaparib in relapsed and refractory chronic lymphocytic leukaemia patients with an 11q deletion or ATM mutation and relapsed/refractory patients with T-prolymphocytic leukaemia and mantle cell lymphoma

Not Recruiting

Open to: All Genders

Age: Adult

Birmingham

Medical Conditions

Chronic lymphocytic leukaemia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Mar 2010 01 Mar 2014

Publications

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28643365 results

Interventional

Intervention Type : Drug
Intervention Description : Phase I:Dose escalation study (cumulative 3 + 3 design) of the PARP inhibitor, olaparib (previously known as AZD2281 and KU-0059436). Two cohorts: 200 mg twice daily (bd) and 400 mg bd for a minimum of 8 weeks. Patients may continue to receive olaparib at the allocated dose for as long as there appears to be clinical benefit (at the discretion of the Investigator). The maximum tolerated dose (MTD) identified in phase I will be used as the dose of olaparib in phase II. All patients will be followed-up for a minimum of 5 years.

Phase II:All patients will receive olaparib (at the dose defined in Phase I) continuously until disease progression or unacceptable toxicity is observed. Response will be assessed at week 16. All patients achieving stable disease, partial remission or complete remission will be offered further treatment with olaparib after 16 weeks.




You can take part if:



You may not be able to take part if:


1. Receiving treatment for CLL, mantle cell lymphoma or T-PLL including corticosteroids (greater than 10 mg prednisone/day or equivalent) or have received treatment for CLL, mantle cell lymphoma or T-PLL for the 4 weeks prior to study entry2. Receiving corticosteroids (at a dose greater than 10 mg prednisone/day or equivalent) for other medical conditions3. Previous treatment with a PARP-inhibitor, including olaparib4. A known hypersensitivity to olaparib or any excipient of the product5. Treatment with any investigational product within 28 days of registration6. Receiving or have received the following inhibitors of CYP34A:6.1. Azole antifungals6.2. Macrolide antibiotics6.3. Protease inhibitors7. Impaired hepatic or renal function as defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 x upper limit of normal (ULN), bilirubin greater than 2 x ULN, serum creatinine greater than 2 x ULN8. Persisting (greater than 8 weeks) severe pancytopenia due to previous therapy rather than disease (neutrophils less than 0.5 x 10^9/L or platelets less than 50 x 10^9/L)9. Central nervous system (CNS) involvement with CLL10. Cardiac dysfunction as defined as: myocardial infarction within 6 months of study entry, New York Heart Association (NYHA) class III/IV heart failure, unstable angina, unstable cardiac arrhythmias11. Any other malignancy which has been active or treated within the past 3 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions or endometrial carcinoma stage 1A grade 112. Unable to swallow orally administered medications13. Patients with uncontrolled seizures14. Active infection requiring systemic antibiotics, antifungal or antiviral drugs15. Concurrent severe and/or uncontrolled medical condition (e.g. severe chronic obstructive pulmonary disease [COPD], severe Parkinsons's disease) or psychiatric condition16. Women of child-bearing potential and men who have partners of child-bearing potential who are not willing to practise effective contraception for the duration of the study and for three months after the last study drug administration17. Pregnancy or lactating women. Pre-menopausal women of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to registration.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University of Birmingham
    Birmingham
    B15 2TT

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Dr Guy Pratt



The study is sponsored by University of Birmingham (UK) and funded by Leukaemia Research Fund (UK).



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Read full details for Trial ID: ISRCTN34386131
Last updated 31 March 2022

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