STEP 3: Diagnosis, staging and treatment planning

Diagnosis for CLL will be confirmed based on full blood count and a thorough physical examination, including all lymph node areas, spleen and liver.

Investigations for baseline assessment and to inform prognosis include: detailed blood chemistry tests, chest radiograph and viral serology.

The following investigations are only recommended under certain circumstances:

  • marrow aspirate and biopsy when the cause of low blood counts is unclear, disease phenotype is inconclusive, or the exact diagnosis is uncertain
  • CT scans PET scan, MRI or ultrasound are not recommended for asymptomatic patients or during routine Exceptions include: PET scans for patients with confirmed or suspected Richter’s syndrome or imaging of bulky or painful lymphadenopathy or significant symptoms or physical findings that suggest a local compressive complication
  • for patients who do have symptoms, or where treatment will be initiated, CT scans are necessary to assess the tumour burden and risk of tumour lysis syndrome.

Molecular genetic testing

The following tests are not recommended at diagnosis but should be done before starting treatment or when there are signs of disease progression that may soon lead to treatment:

  • interphase FISH for del(13q), del(11q), del(17p), +12 and DNA sequencing for the presence of a TP53 mutation
  • IGHV mutational

Treatment planning

The multidisciplinary team should discuss patients with CLL before starting any disease-directed therapy.

Research and clinical trials

Consider enrolment where available and appropriate.

See the OCP resources appendix and relevant steps for clinical trial resources relevant to CLL.


The lead clinician’s1 responsibilities include:

  • discussing a timeframe for diagnosis and treatment options with the patient and/or carer
  • explaining the role of the multidisciplinary team in treatment planning and ongoing care
  • encouraging discussion about the diagnosis, prognosis, advance care planning and palliative care while clarifying the patient’s wishes, needs, beliefs and expectations, and their ability to comprehend the communication
  • providing appropriate information and referral to support services as required
  • communicating with the patient’s GP about the diagnosis, treatment plan and recommendations from multidisciplinary meetings.


  • Diagnosis has been confirmed
  • Performance status and comorbidities measured and recorded
  • Patient discussed at multidisciplinary meetings and decisions provided to the patient and/or carer
  • Clinical trial considered
  • Supportive care needs assessed and referrals to allied health services actioned as required
  • Referral to support services (such as Cancer Council, Leukaemia Foundation, Lymphoma Australia)
  • Treatment costs discussed with the patient and/or carer


Baseline investigations should be performed 2–4 weeks before starting treatment, CT scans can be done up to 2 months prior. Molecular cytogenetics (FISH), marrow aspirate and biopsy can be performed up to 12 months before starting treatment, provided that there have been no intervening therapies and the general disease course is unchanged.

1 Lead clinician – the clinician who is responsible for managing patient care. The lead clinician may change over time depending on the stage of the care pathway and where care is being provided.