Phase 2 Lymphoma Trial, Recruiting NCT03571568 Sponsor: BioInvent International AB Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT03571568
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 18 years of age or older at the time treatment begins
  • People who have a type of B-cell non-Hodgkin lymphoma (a blood cancer) confirmed by a tissue test, specifically follicular lymphoma (but not a subtype called grade 3B), mantle cell lymphoma, or marginal zone lymphoma
  • People who have measurable disease in their lymph nodes
  • People who are willing to have a biopsy (a small tissue sample taken) from a lymph node or other affected area
  • People whose lymphoma has come back after treatment, has stopped responding to standard treatment, or for whom no standard treatment exists
  • People who have already received at least one course of standard treatment, which must have included a drug called rituximab
  • People who are expected to live for at least 12 weeks
  • People who are reasonably well and able to carry out daily activities — assessed using a standard medical scale rated 0 to 2 (confirm with trial site)
  • People whose cancer cells carry a marker called CD20 on their surface
  • People whose blood counts and organ function results fall within the ranges required by the trial (confirm with trial site)

Who may not be able to join:

  • People who have had a bone marrow or stem cell transplant from a donor within the past 12 months
  • People who currently have active graft versus host disease (a condition where donor cells attack the body after a transplant)
  • People who have lymphoma affecting the brain, spinal cord, or the fluid surrounding them
  • People whose lymphoma has changed (transformed) from a slower-growing type of lymphoma
  • People who have a condition called Waldenström's Macroglobulinemia, or follicular lymphoma grade 3B
  • People who need high daily doses of steroid medication (such as prednisolone above 10 mg per day) during the trial, except as a pre-medication (confirm with trial site)
  • People who are known or suspected to have an allergy to rituximab or the trial drug BI-1206
  • People who have a specific type of protein build-up in the heart or kidneys called cardiac or renal amyloid light-chain amyloidosis
  • People who have recently received certain treatments, including: chemotherapy or certain targeted drugs within 2 weeks, radiation therapy within 4 weeks (except for specific symptom relief), immunotherapy within 8 weeks, or previous treatment with a class of drugs called BTK inhibitors (for those in a specific part of the trial)
  • People who are still experiencing significant side effects from previous treatments
  • People who are pregnant, breastfeeding, or able to become pregnant
  • People who have had major surgery from which they have not yet fully recovered
  • People who have a serious non-cancer illness, including an active infection currently being treated with antibiotics, antifungal, or antiviral medicines
  • People who test positive for hepatitis B, hepatitis C, or HIV
  • People who have an active autoimmune disease (where the immune system attacks the body)
  • People who have significant heart failure or a history of serious heart disease (classed as Grade III or IV on a standard heart health scale)
  • People who currently have another type of active cancer

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

Phone: +46706126618

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
Sponsor
BioInvent International AB
Registry
ClinicalTrials.gov
Start date
16 May 2018
Est. completion
30 September 2026

Where this trial is recruiting

🇧🇷 Brazil 🇩🇪 Germany 🇵🇱 Poland 🇪🇸 Spain 🇸🇪 Sweden 🇺🇸 United States

Primary endpoints

Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib; Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or Rituximab-related or possibly related dose-limiting toxicity (DLT); Determine the recommended dose of BI-1206 in combination with rituximab and acalabrutinib

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