Phase 4 Lymphoma Trial, Recruiting NCT06831370 Sponsor: Takeda Condition: Lymphoma
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Phase 4 Lymphoma Trial, Recruiting

NCT06831370
Recruiting Phase 4

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 aged 18 or older who have been diagnosed with classical Hodgkin lymphoma (a type of blood cancer) at Stage 3 or 4, confirmed by a tissue sample analysis, and who have not yet received any treatment for it.
  • People whose lymphoma can be measured in two dimensions on a scan (such as a CT scan), which helps doctors track how the disease responds to treatment.
  • People whose cancer is visible and measurable on imaging as defined by standard international guidelines for lymphoma assessment.
  • People who are reasonably able to carry out daily activities, as measured by a standard medical scale called the ECOG score of 0, 1, or 2 (confirm with trial site).
  • Women who are postmenopausal for at least one year, surgically unable to have children, or who agree to use one highly effective and one additional barrier method of contraception together from the time of consent until six months after the last dose of study treatment — or who agree to complete abstinence if that is consistent with their usual lifestyle.
  • Men, including those who have had a vasectomy, who agree to use effective barrier contraception throughout the treatment period and for six months after the last dose — or who agree to complete abstinence if that is consistent with their usual lifestyle.
  • People who are willing to give written consent to participate and understand they may withdraw at any time without affecting their future medical care.
  • People whose recent blood test results (taken within 7 days before starting treatment) meet all of the following:
    • A white blood cell count (neutrophils) of at least 1,000 per microlitre, unless the bone marrow is affected by lymphoma
    • A platelet count of at least 75,000 per microlitre, unless the bone marrow is affected by lymphoma
    • Liver function values within acceptable ranges (specific limits apply — confirm with trial site)
    • Kidney function within acceptable ranges (specific limits apply — confirm with trial site)
    • A haemoglobin (red blood cell) level of at least 8 grams per decilitre

Who may not be able to join:

  • Women who are currently breastfeeding, or who have a positive pregnancy test at screening or on the first day of treatment.
  • People with a serious medical or psychiatric condition that, in the doctor's opinion, could interfere with completing the treatment as planned.
  • People with known cancer involvement in the brain or the membranes surrounding the brain or spinal cord, or signs of a serious brain condition called progressive multifocal leukoencephalopathy (PML).
  • People with neurological symptoms that affect their ability to carry out daily activities or that require ongoing medication.
  • People who have any nerve damage affecting sensation or movement (peripheral neuropathy) of any kind.
  • People who have an active infection — viral, bacterial, or fungal — that requires antibiotic or antifungal treatment within two weeks before the first dose.
  • People who have received chemotherapy that suppresses the immune system, radiation therapy, or any immunotherapy within 12 weeks before the first dose.
  • People who have previously been treated with a drug called brentuximab vedotin.
  • People who have a medical reason they cannot receive the chemotherapy drugs used in this trial (doxorubicin, vinblastine, and dacarbazine).
  • People with a known allergy or sensitivity to any of the components of brentuximab vedotin or the chemotherapy drugs used in this trial.
  • People who are known to be HIV positive.
  • People with known active hepatitis B or known or suspected active hepatitis C infection.
  • People who have been diagnosed with or treated for another cancer within the past three years, or who have any remaining signs of a previously diagnosed cancer — except for certain fully removed skin cancers or non-invasive (in situ) cancers.
  • People who have had any of the following heart-related conditions within the six months before the first dose: a heart pumping function below 50%, a heart attack within two years of enrolment, moderate-to-severe heart failure (NYHA Class 3 or 4), or uncontrolled heart conditions such as irregular heartbeat, chest pain, or abnormal heart electrical activity (confirm with trial site).
  • People with moderate or severe liver disease as assessed by a standard medical scoring system called Child-Pugh criteria.

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 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: +1-877-825-3327

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Registry
ClinicalTrials.gov
Start date
28 August 2024
Est. completion
31 March 2028

Where this trial is recruiting

🇮🇳 India

Primary endpoints

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Unexpected ADRs

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: 20 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