Phase 2 Lymphoma Trial, Recruiting NCT05868395 Sponsor: Medical University of Vienna Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05868395
Recruiting Phase 2

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:

  • People who are able to understand the purpose of the study and have provided written consent to participate
  • People aged 18 years or older
  • People who have been diagnosed with mantle cell lymphoma (a type of blood cancer) that has come back or stopped responding to treatment, confirmed by a tissue or cell sample
  • People whose mantle cell lymphoma returned or stopped responding after standard first-line chemotherapy, and who have received at least one previous treatment that included a drug called ibrutinib
  • People who previously received a drug called bendamustine, where that treatment kept the disease under control for more than one year
  • People who have at least one measurable lymph node or tumour mass that can be tracked during the study
  • People with a life expectancy of at least 24 weeks (roughly six months)
  • People with a general health and activity level rated 0 to 2 on a standard medical scale (meaning able to carry out daily activities with no more than moderate limitations) (confirm with trial site)
  • People with adequate blood, kidney, and liver function — or whose results are below normal only because of the underlying disease itself

Who may not be able to join:

  • People with a history of severe allergic or life-threatening reactions to certain types of antibody-based medicines, or known sensitivity to the drugs bendamustine or rituximab
  • People for whom the study drugs polatuzumab, bendamustine, or rituximab are medically unsuitable
  • People who have received certain antibody-based treatments within four weeks or five half-lives before the study starts
  • People who have taken part in another clinical trial using an experimental drug within 28 days before starting this study
  • People who have had another cancer (other than certain skin cancers or a specific type of cervical pre-cancer) within the last three years
  • People who have received radiotherapy, chemotherapy, immunotherapy, or other cancer treatments within two weeks before the study starts
  • People who have had major surgery or a serious injury within 28 days before the first study dose
  • People who are currently taking corticosteroid medicines (such as prednisone) at doses above 30 mg per day for reasons unrelated to lymphoma symptoms
  • People who had an autologous stem cell transplant (a procedure using their own stem cells) within 100 days before the study starts
  • People who have previously had an allogeneic stem cell transplant (using stem cells from a donor)
  • People who are considered eligible for an autologous stem cell transplant
  • People whose lymphoma has spread to the brain or spinal cord
  • People who currently have moderate or severe nerve damage (such as numbness, tingling, or pain in the hands or feet) rated above Grade 1
  • People with serious uncontrolled health conditions, including significant heart disease (such as a heart attack in the past six months, unstable heart rhythm, or severe heart failure) or significant lung disease
  • People with an active infection at the time of enrolment, or who have been hospitalised or needed intravenous antibiotics for an infection within four weeks before the study starts
  • People with suspected or inactive (latent) tuberculosis
  • People who test positive for chronic hepatitis B or hepatitis C
  • People known to be living with HIV or HTLV-1 (a virus affecting the immune system)
  • People who are pregnant, breastfeeding, or planning to become pregnant within one year of the last study dose
  • Women who could potentially become pregnant and are unwilling or unable to use adequate contraception from the start of the study until the last dose
  • Women who could potentially become pregnant and who have a positive pregnancy test at screening, or whose pregnancy test was not performed within seven days before the first study treatment
  • Male participants who are unwilling or unable to use adequate contraception methods during the study
  • People whose routine blood test results show abnormal kidney, liver, or blood clotting function

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 7 July 2026
Phase 2: approximately ~30% 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.

Contact this trial

Principal Investigator: Barbara Kiesewetter, MD, Medical University Vienna

Phone: +43140400

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

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
2 January 2024
Est. completion
24 May 2027

Where this trial is recruiting

🇦🇹 Austria

Primary endpoints

Objective response rate

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: 7 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