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LymphomaPhase 1/2NCT01354392

AZD1152 in Diffuse Large B-cell Lymphoma

A Phase 1/2 study testing AZD1152 in people with Lymphoma, run by Oxford University Hospitals NHS Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Diffuse large B-cell lymphoma is the commonest type of aggressive non-Hodgkin's lymphoma, a type of cancer of a cell called a lymphocyte which makes up part of the immune system. Although most patients are cured with chemotherapy used as initial treatment, about 20-30% of patients still experience relapse. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
AZD1152
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited Kingdom
Study dates
Sep 2011to Sep 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female, aged ≥ 18 yrs.
  • ECOG performance score of 0, 1 or 2.
  • Life expectancy of at least 12 weeks.
  • Haematological and biochemical indices within the ranges shown below Lab Test Value required Haemoglobin (Hb) ≥ 9g/dL White Blood Count (WBC) ≥ 2x109/L Platelet count ≥ 100x109/L Absolute Neutrophil count ≥ 1.0x109/L; Serum bilirubin ≤ 1.5 x ULN AST (SGOT) or ALT ≤ 1.5 x ULN Creatinine clearance (Cockcroft-Gault) > 50 ml/min
  • Relapsed or refractory DLBCL in which all participants must have received at least one potentially curative established immunochemotherapy lymphoma regimen that contained rituximab (e.g. R-CHOP, R-PMitCEBO, R-GCVP, R-CNOP). Participants must also have failed or be ineligible for salvage/high dose therapy.
  • Relapsed or refractory DLBCL proven by biopsy (within 6 months of enrolment in trial); either de novo DLBCL or transformed follicular lymphoma.
  • At least 1 lesion (> 1.5cm), not previously irradiated, that can be accurately measured on CT and which is FDG avid on CT-PET scanning, as defined by Cheson criteria.
  • Able to give informed consent and capable of co-operating with protocol.

Who cannot join

  • Any anti-cancer therapy (including radiotherapy and participation in other clinical trials) within 28 days prior to Day 1. Patients may however be receiving corticosteroids as an anti-lymphoma treatment of 50mg daily prednisolone or equivalent up until screening. At screening (or before) this must be tapered down so that they are only on a low dose (10mg daily or less) by the time AZD1152 commences. This may be continued for indications other than lymphoma treatment throughout the study.
  • Any unresolved toxicity from prior anti-cancer therapy greater than CTCAE grade I (except alopecia).
  • Previous treatment with aurora kinase inhibitors.
  • Clinical evidence of central nervous system involvement.
  • Another active malignancy within the past five years, except adequately treated basal or squamous cell carcinoma of the skin, or carcinoma of the cervix in situ.
  • Clinically significant and uncontrolled major medical condition(s) including but not limited to: active infection, bleeding diathesis, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations which would limit compliance with protocol requirements.
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  • Major surgery within 4 weeks prior to entry into the study (excluding placement of vascular access or biopsy) that involved general anaesthesia or respiratory assistance.
  • Mean QTc interval > 470 ms calculated from 3 ECGs using Fridericia's or Bazett's correction on 12-lead ECG machine.
  • Serologically positive for HIV, hepatitis B or C assessed within 28 days of initiation of study treatment using an ELISA method performed by an HPA accredited laboratory.
  • Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study (both male and female participants).
  • Pregnant or breastfeeding women. Female participants must have a negative urinary or serum pregnancy test when done or have evidence of post-menopausal status (Defined as absence of menstruation for greater than 12 months, bilateral oophorectomy or hysterectomy).
  • Participants who have had live attenuated or yellow fever vaccines within 6 months of trial beginning.
  • Participants not willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Christie NHS Foundation Trust (Christie Hospital)

    Machester, Lancashire, M20 4BX

  • Oxford Radcliffe NHS Trust (Cancer & Haematology Centre, Churchill Hospital)

    Oxford, Oxfordshire, OX3 7LJ

Other trials in United Kingdom

About this study

Official title: A Phase 2 Trial of AZD1152 in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Diffuse large B-cell lymphoma is the commonest type of aggressive non-Hodgkin's lymphoma, a type of cancer of a cell called a lymphocyte which makes up part of the immune system. Although most patients are cured with chemotherapy used as initial treatment, about 20-30% of patients still experience relapse. Curing relapsed disease is much less successful, even with the use of high doses of chemotherapy and stem cell transplant. There is then an urgent need for effective, new agents to treat patients with diffuse large B-cell lymphoma who have relapsed or who have developed resistance to other forms of chemotherapy.

This trial is using a drug called AZD1152 which interferes with the ability of a cancer cell to divide and grow. It has been used before in patients with other types of cancer, but never before in lymphoma patients. Responses in other cancers have been seen, particularly in leukaemia which is a disease related to lymphoma. The investigators are planning to use this agent in 15 patients with diffuse large B-cell lymphoma in which potentially curative treatments have failed. The main aim is to see whether the drug shows any activity in this type of lymphoma. This will be mainly assessed using CT and PET scans. The investigators are also investigating how well a blood test can predict both the response to the drug and the toxicity of the drug - this is called a biomarker study and forms part of the clinical trial. The other main aim of the study is to assess the toxicity of the treatment. Previous studies in humans suggest the drug is reasonably well tolerated, although side effects such as stomatitis (soreness of the mouth) and suppression of the bone marrow (leading to risk of infection and bleeding) have been seen.

Conditions
Lymphoma
Being tested
AZD1152
Keywords
Relapsed or refractory, Large B-Cell, Diffuse
Medical subject headings
Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD1152Drug

    Up to 6 cycles. Each cycle consists of 800 mg. IV infusion over 96 hrs.

Study groups in NCT01354392
Study groupRoleWhat they receive
AZD1152ExperimentalNot described
Receives: Drug: AZD1152

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR; Cheson 2007 criteria)

    Measured: ORR will be calculated from the data obtained from the End Visit, which occurs approx. 14 days after the end of the last cycle of treatment the patient undergoes.

Secondary outcomes (3)

  1. Progression free survival at 1 year

    Measured: PFS will be calculated at some point 1-year post-study from the available 1 year post-study data.

  2. Percentage change in tumour size

    Measured: Percentage change in tumour size will be calculated from the data obtained from the End Visit, which occurs approx. 14 days after the end of the last cycle of treatment the patient undergoes.

  3. Safety of AZD1152

    Measured: The safety of AZD1152 is monitored at every study visit on study via recording AEs/SAEs/SUSARs. However, these are also recorded as they arise. E.g. they would be recorded if the patient had an emergency admissions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01354392
Sponsor's protocol ID
ORH/PID/6265
Status last verified
Jul 2014
First submitted
13 May 2011
Last updated
2 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Collins GP, Eyre TA, Linton KM, Radford J, Vallance GD, Soilleux E, Hatton C. A phase II trial of AZD1152 in relapsed/refractory diffuse large B-cell lymphoma. Br J Haematol. 2015 Sep;170(6):886-90. doi: 10.1111/bjh.13333. Epub 2015 Feb 26. No abstract available.

    PubMed 25721307

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AZD1152 in people with Lymphoma, run by Oxford University Hospitals NHS Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR; Cheson 2007 criteria) (time frame: ORR will be calculated from the data obtained from the End Visit, which occurs approx. 14 days after the end of the last cycle of treatment the patient undergoes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01354392, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.

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