EUCTR2016-001966-27-LVActive, not recruitingPhase 1
A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients with Low Tumor Burden Follicular Lymphoma
Archigen Biotech Limited0 sites308 target enrollmentStarted: December 7, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 308
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Patients with histologically-confirmed, Ann Arbor stage II – IVA CD20+ Follicular Lymphoma (FL) (Grades 1, 2, or 3a), aged at least 18 years, not previously treated for their FL, low tumor burden according to Groupe D’Etude des Lymphomes Folliculaires (GELF) criteria, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, at least one measurable lesion per the International Working Group (IWG) criteria 2007 at screening, no evidence of transformation to a large cell histology, and adequate hematological, renal, and liver function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 274
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
Exclusion Criteria
- •1. Previous treatment with any chemotherapy and/or rituximab or other monoclonal antibody.
- •2. Prior radiotherapy completed <28 days before study enrollment.
- •3. Anticipated need for concomitant administration of any other experimental drug, or a concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy during study participation.
- •4. Concomitant disease which requires continuous therapy with corticosteroids at doses equivalent to prednisolone >20 mg/day.
- •5. Leukemia or transformation to diffuse large B cell lymphoma secondary to previously untreated follicular lymphoma.
- •6. Prior or concomitant malignancies within 5 years prior to screening, with the exceptions of non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, adequately treated breast cancer in situ, and localized prostate cancer stage T1c, provided that the patient underwent curative treatment and remains relapse free.
- •7. Patients with a body surface area >3.0 m2.
- •8. Major surgery (excluding lymph node biopsy) within 28 days prior to randomization.
- •9. Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus (HIV) infection or positive test at screening.
- •10. Acute, severe infection (e.g., sepsis and opportunistic infections), or active, chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., herpes zoster).
- •11. Positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C serology.
- •? Patients with a negative HBsAg and positive HBcAb must have a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level <20 IU/mL (or 112 copies/mL) by polymerase chain reaction (PCR). These HBV patients must be willing to undergo PCR HBV DNA testing during treatment and may participate following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated. An HBV re-test will be performed at each study visit from Week 5 onwards, and at the discretion of the Investigator.
- •? Patients with a positive test because of HBV vaccine may be included (i.e., anti-HBs+, anti-HBc–).
- •? Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV ribonucleic acid (RNA).
- •12. Confirmed current active tuberculosis (TB). Patients with latent TB as determined by tuberculosis skin testing (e.g. Mantoux test) or interferon-gamma release assay (IGRA e.g.QuantiFERON-TB test) may be enrolled if such patients have written confirmation from their health care provider (e.g., Pulmonologist or Infection Specialist) of adequate prophylaxis before or within the screening period, and no evidence of tuberculosis on a chest X-ray performed within 3 months of Day 1 or chest CT.
- •13. Central nervous system (CNS) or meningeal involvement, or cord compression by the lymphoma; history of CNS lymphoma. A brain (CT or MRI) scan should be conducted at screening ONLY if lesions are suspected on the brain, to exclude patients with brain localization of FL.
- •14. History of a severe allergic reaction or anaphylactic reaction to a biological agent o
Investigators
Similar Trials
Active, not recruiting
Phase 1
A Study Comparing SAIT101 to MabThera® in Patients with Low Tumor Burden Follicular LymphomaEUCTR2016-001966-27-FRArchigen Biotech Limited308
Active, not recruiting
Phase 1
A Study Comparing SAIT101 to MabThera® in Patients with Low Tumor Burden Follicular Lymphomaow Tumor Burden Follicular Lymphoma (LTBFL)MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2016-001966-27-HRArchigen Biotech Limited308
Not yet recruiting
Phase 3
A clinical trial to study the effects of two drugs SAIT101 and Rituximab for treatment in patients with low tumor of follicular lymphoma (cancer of the immune system)CTRI/2017/07/009035Archigen Biotech Limited308
Active, not recruiting
Phase 1
A Study Comparing SAIT101 to MabThera® in Patients with Low Tumor Burden Follicular Lymphomaow Tumor Burden Follicular Lymphoma (LTBFL)MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2016-001966-27-HUArchigen Biotech Limited315
Active, not recruiting
Phase 1
A Study Comparing SAIT101 to MabThera® in Patients with Low Tumor Burden Follicular Lymphomaow Tumor Burden Follicular Lymphoma (LTBFL)MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2016-001966-27-GBArchigen Biotech Limited308