Phase 3 Lymphoma Trial, Completed NCT02809053 Sponsor: Archigen Biotech Limited Condition: Lymphoma
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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 enrolled 315 people in total — 157 in the SAIT101 group and 158 in the MabThera group. The trial was comparing these two medicines, with SAIT101 being tested as a potential biosimilar (a very closely related copy) of MabThera, which is an already-approved medicine. The main thing the trial was measuring was how many participants showed a meaningful reduction in their condition — called an "overall response" — by week 28. Most participants completed the study, with 150 in the SAIT101 group and 152 in the MabThera group finishing the full follow-up period. The reported data shows that at week 28 (the main measurement point), 66.3% of participants in the SAIT101 group and 70.6% in the MabThera group had an overall response (meaning their condition showed either a complete or partial reduction). At the earlier check-in point of week 12, the reported figures were 59.6% for SAIT101 and 70.0% for MabThera. Looking at more detailed breakdowns, at week 28 the number of participants recorded as having a complete reduction was 51 (SAIT101) and 50 (MabThera), while a partial reduction was recorded in 47 (SAIT101) and 53 (MabThera) participants. Stable disease — meaning no clear change either way — was recorded in 22 and 27 participants respectively, and progressive disease (the condition worsening) was recorded in 20 (SAIT101) and 11 (MabThera) participants at week 28. 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.

Phase 3 Lymphoma Trial, Completed

NCT02809053
Completed Phase 3 🇦🇺 Australian site

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 follicular lymphoma (a type of slow-growing blood cancer) confirmed by a tissue sample, at stage II or higher, and your cancer cells test positive for a marker called CD20, with a grade of 1, 2, or 3a.
  • Your lymphoma is considered "low tumor burden," meaning your blood test results, swollen lymph nodes, and organ sizes fall within certain limits set by a medical guideline called the GELF criteria (confirm with trial site for your specific test results).
  • You do not have symptoms such as persistent fever, heavy night sweats, or significant unexplained weight loss (more than 10% of your body weight in 6 months).
  • You have no tumors larger than 7 cm, fewer than 3 swollen lymph nodes larger than 3 cm, and no dangerous fluid build-up around your lungs or abdomen.
  • Your blood counts (platelets, red blood cells, and white blood cells) are within acceptable ranges.
  • You have never previously been treated for your follicular lymphoma, except possibly localized radiation therapy for an earlier limited-stage diagnosis.

Who may not be able to join:

  • You have previously received chemotherapy, rituximab, or any other monoclonal antibody treatment.
  • You had radiation therapy fewer than 28 days before joining the study.
  • You will need to take other experimental drugs, chemotherapy, hormone-based cancer treatment, radiation, or immunotherapy at the same time as this trial.
  • You currently need ongoing treatment with high-dose steroid medications (equivalent to more than 20 mg per day of prednisolone).
  • Your lymphoma has changed into a faster-growing, higher-grade type.
  • You have had another cancer within the past 5 years, with some exceptions such as certain treated skin cancers, cervical cancer in situ, breast cancer in situ, or a very early-stage prostate cancer — provided you were fully treated and have had no recurrence (confirm with trial site).
  • Your body surface area is calculated to be greater than 3.0 m² (confirm with trial site).
  • You have had major surgery (other than a lymph node biopsy) within 28 days before joining the study.
  • You have a known immune system disorder, or you are HIV positive.
  • You have a serious active infection, or a long-lasting infection that could get worse if your immune system is suppressed.
  • You have tested positive for hepatitis B or hepatitis C.
  • You currently have active tuberculosis (TB).
  • Your lymphoma has spread to your brain, spinal cord, or the lining around them, or you have a history of lymphoma in the brain.
  • You have had a severe allergic reaction to a biological medicine, or you are allergic to any component of the trial drug, including products derived from mice.
  • You have significant heart problems, such as serious heart failure, unstable chest pain, or uncontrolled irregular heartbeat.
  • You have uncontrolled high blood pressure or a history of stroke or other brain blood vessel disease.
  • You have other serious medical or psychological conditions that the doctor feels would prevent you from safely participating.
  • You have taken any other experimental or unapproved drug within 4 weeks (or longer, depending on the drug) before starting the trial.
  • You have received a live or weakened vaccine within 6 weeks before your screening appointment.
  • You are pregnant, breastfeeding, or planning to become pregnant during treatment or within 12 months after your last dose.
  • You are a staff member at the trial site, a family member of such staff, or an employee of the company running the trial who is directly involved in its conduct.

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

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
Archigen Biotech Limited
Registry
ClinicalTrials.gov
Start date
18 January 2017
Est. completion
17 July 2019

Where this trial is recruiting

🇦🇺 Australia 🇨🇱 Chile 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇲🇽 Mexico 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Overall Response Rate (ORR) at Week 28

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