Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 276 people in each of two groups — a total of 552 participants — all of whom had a type of blood cancer called chronic lymphocytic leukaemia. One group received two chemotherapy medicines together (fludarabine and cyclophosphamide, called FC), and the other group received those same two medicines plus a third medicine called rituximab (called FCR). The trial was mainly measuring how long participants went without their disease getting worse (called "progression-free survival"), and also tracked how long participants lived overall and how long before any major setback occurred. The reported data shows that, for the main measure — time without disease getting worse as judged by an independent review panel — the FC group had a reported median (middle value) of 660 days, while the FCR group had a reported median of 813 days. In terms of how many people experienced a worsening of their disease or death during the study, the reported data shows 148 people in the FC group and 137 in the FCR group had such an event. For overall survival (time until death from any cause), the FC group had a reported median of 1,580 days; a median figure for the FCR group was not reported in the data. The number of deaths recorded was 68 in the FC group and 62 in the FCR group. For the additional measure of "event-free survival" — which also counted starting a new treatment as an event — the reported medians were 586 days for FC and 874 days for FCR. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 24916506) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Leukaemia Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 18 years of age or older
- You have been diagnosed with a type of blood cancer called B-cell chronic lymphocytic leukemia (CLL), confirmed using standard medical guidelines
- You have received no more than one previous round of chemotherapy
- Your doctors expect you to live for more than 6 months
- Your blood counts, liver, kidneys, and lungs are functioning at an acceptable level (confirm with trial site)
- If you are a woman who could become pregnant or who has gone through menopause within the last 2 years, you have a negative pregnancy test
- You are willing and able to sign a consent form agreeing to take part in the study
Who may not be able to join:
- You have previously been treated with interferon, rituximab, or any similar antibody-based therapy
- You have had a bone marrow or stem cell transplant in the past, or your doctor considers you a candidate for one
- You are a man or woman who could have children and are not using reliable contraception
- You had serious or long-lasting severe side effects from a previous treatment with fludarabine or a similar drug (confirm with trial site)
- You have a history of a blood disorder caused by fludarabine or a similar condition affecting your blood cells
- You have had another type of cancer in the last 2 years, with some exceptions for certain early-stage or low-risk cancers that were fully treated (confirm with trial site)
- You need to take steroid medications (such as prednisone) long-term, meaning for more than one month
- You currently have an active bacterial, viral, or fungal infection that requires medication
- You have serious heart disease
- You have seizures that require medication to control them
- You have severe lung disease that causes low oxygen levels in your blood
- You have diabetes or high blood pressure that is not well controlled
- Your CLL has changed into a more aggressive form of blood cancer
- You are known to be infected with HIV, hepatitis C, or hepatitis B
- You have taken part in another clinical trial or received an experimental treatment within the last 30 days
- You have had a serious allergic reaction to certain antibody-based treatments derived from mouse proteins
- You have any other medical or mental health condition that would make it difficult or unsafe for you to participate in the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC); Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC); Final Analysis: Time to Progression-Free Survival Event
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.