Phase 3 Lymphoma Trial, Completed (NCT01197560)

Phase 3 Lymphoma Trial, Completed NCT01197560 Sponsor: Celgene Condition: Lymphoma

Printed from Voxsanity (voxsanity.com.au) — NCT01197560 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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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 (NCT01197560) enrolled 54 people in the lenalidomide group and 57 people in a control group who received a treatment of their doctor's choice ("Investigator's Choice"). The trial was measuring how many participants with a type of blood cancer called non-Hodgkin's lymphoma showed a response to treatment — meaning their cancer shrank or disappeared according to standardised criteria. Responses were assessed both by an independent review committee and by the treating doctors themselves. The reported data shows that, based on the independent committee's review, approximately 27.5% of participants in the lenalidomide group and 11.8% in the control group showed an overall response (meaning their cancer shrank or disappeared to a defined degree). When the treating doctors made the same assessment, the figures were approximately 29.4% for the lenalidomide group and 13.7% for the control group. The reported data also shows that around 23.5% of the lenalidomide group and 9.8% of the control group maintained their response for at least 16 weeks. A complete disappearance of disease was reported in approximately 13.7% of the lenalidomide group compared to 3.9% in the control group. Among those who did respond, the estimated duration of that response was reported as approximately 64.7 weeks for the lenalidomide group and 63.1 weeks for the control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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.

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 have been diagnosed with a specific type of blood cancer called Diffuse Large B-Cell Lymphoma (DLBCL), confirmed by a tissue sample test.
Your lymphoma has come back or stopped responding to treatment that included at least two types of chemotherapy combinations (one of which contained the drugs rituximab and an anthracycline), or a stem cell transplant.
Your lymphoma can be seen and measured on a CT or MRI scan.
You are generally able to carry out daily activities, ranging from fully active to capable of basic self-care (confirm with trial site for exact fitness level requirements).

Who may not be able to join:

You have been diagnosed with a different type of lymphoma that is not DLBCL.
You have had another type of cancer in the past, unless you have been completely free of that cancer for 3 or more years.
You are considered a suitable candidate for a type of stem cell transplant using your own stem cells.
You have tested positive for HIV, hepatitis B, or hepatitis C, or have a history of any of these infections.
You have severe nerve damage affecting your daily functioning (confirm with trial site for exact definition).

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 2 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT01197560

Sponsor: Celgene

Phase: Phase 3

Status: Completed

Condition: Lymphoma

More information: https://clinicaltrials.gov/study/NCT01197560

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have been diagnosed with a specific type of blood cancer called Diffuse Large B-Cell Lymphoma (DLBCL), confirmed by a tissue sample test.
Your lymphoma has come back or stopped responding to treatment that included at least two types of chemotherapy combinations (one of which contained the drugs rituximab and an anthracycline), or a stem cell transplant.
Your lymphoma can be seen and measured on a CT or MRI scan.
You are generally able to carry out daily activities, ranging from fully active to capable of basic self-care (confirm with trial site for exact fitness level requirements).

Who may not be able to join:

You have been diagnosed with a different type of lymphoma that is not DLBCL.
You have had another type of cancer in the past, unless you have been completely free of that cancer for 3 or more years.
You are considered a suitable candidate for a type of stem cell transplant using your own stem cells.
You have tested positive for HIV, hepatitis B, or hepatitis C, or have a history of any of these infections.
You have severe nerve damage affecting your daily functioning (confirm with trial site for exact definition).

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 2 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Phase 3

Sponsor

Celgene

Registry

ClinicalTrials.gov

Start date

2 September 2010

Est. completion

4 July 2013

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇿 Czechia 🇫🇷 France 🇮🇹 Italy 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Stage 1: Percentage of Participants With an Overall Response According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 and Evaluated by the Independent Response Adjudication Committee (IRAC); Stage 1: Percentage of Participants With an Overall Response According to the IWG Response Criteria Based on the Investigators Assessment at the Final Data Cut During the Core Treatment Phase

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov