NCT02809053

Brief Summary

This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2017

Typical duration for phase_3

Geographic Reach
14 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

January 18, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 8, 2020

Completed
Last Updated

October 8, 2020

Status Verified

September 1, 2020

Enrollment Period

2.5 years

First QC Date

June 20, 2016

Results QC Date

July 20, 2020

Last Update Submit

September 14, 2020

Conditions

Lymphoma, Follicular

Keywords

low tumor burden follicular lymphoma (LTBFL)

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR) at Week 28

    Overall Response Rate (ORR) (Complete Response \[CR\] + Partial Response \[PR\]) at Week 28, as defined by International Working Group (IWG) criteria 2007. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007. The 95% CI for overall response rate (ORR) was calculated using the Exact method and combined using the Rubin's rule when multiple imputation was applicable.

    Baseline (Day 0) to Week 28.

Secondary Outcomes (6)

  • Overall Response Rate (ORR) at Week 12

    Baseline (Day 0) to Week 12

  • Complete Response (CR) at Weeks 12 and 28

    Baseline (Day 0) to Week 12 and Week 28.

  • Partial Response (PR) at Weeks 12 and 28

    Baseline (Day 0) to Week 12 and Week 28.

  • Stable Disease (SD) at Weeks 12 and 28

    Baseline (Day 0) to Week 12 and Week 28.

  • Progressive Disease (PD) at 12 and 28 Weeks

    Baseline (Week 0)to Week 12 and Week 28.

  • +1 more secondary outcomes

Other Outcomes (13)

  • Truncated Area Under the Concentration-time Curve (AUC) Over the First and Fourth Dosing Intervals (AUC0 168,w1, AUC0-168,w4).

    Baseline (Day 0) to dosing on Week 1 and Week 4

  • Maximum Concentration (Cmax) After the First Dose and the Fourth Dose (Cmax,w1, Cmax,w4).

    Baseline (Day 0) to dosing on Week 1 and Week 4

  • Accumulation Ratio for AUC0-168 Obtained From the Fourth Dose Versus the First Dose (RAUC).

    Baseline (Day 0) to dosing on Week 1 and Week 4

  • +10 more other outcomes

Study Arms (2)

SAIT101

EXPERIMENTAL
Biological: SAIT101

MabThera®

ACTIVE COMPARATOR
Biological: MabThera®

Interventions

SAIT101BIOLOGICAL

Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22

SAIT101
MabThera®BIOLOGICAL

Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22

Also known as: Rituximab
MabThera®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically-confirmed Low Tumor Burden Follicular Lymphoma, without B symptoms, Ann Arbor stage II to Non-Hodgkin's Lymphoma (NHL) (CD20+ Follicular Lymphoma of Grades 1, 2, or 3a)
  • Low tumor burden according to The Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria defined as:
  • Normal serum lactate dehydrogenase (LDH)
  • No mass ≥7 cm.
  • Less than 3 nodal sites, each with diameter \>3 cm
  • No systemic or B symptoms (fever \>38°C for 3 consecutive days; recurrent, drenching night sweats; unintentional weight loss exceeding 10% body weight in the last 6 months.
  • No splenomegaly ≥16 cm by CT scan.
  • No risk of vital organ compression.
  • No pleural or peritoneal serous effusion.
  • No leukemic phase \>5,000/µL circulating tumor cells.
  • No cytopenias (defined as platelets \<100,000/mm3, hemoglobin \<10 g/dL, or absolute neutrophil count \<1,500/mm3).
  • Patients not previously treated for their FL, including any previous treatment for FL under clinical trials except localized radiation therapy for previous limited stage disease.

You may not qualify if:

  • Previous treatment with any chemotherapy and/or rituximab or other monoclonal antibody.
  • Prior radiotherapy completed \<28 days before study enrollment.
  • Anticipated need for concomitant administration of any other experimental drug, or a concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy during study participation.
  • Concomitant disease which requires continuous therapy with corticosteroids at doses equivalent to prednisolone \>20 mg/day.
  • Transformation to high-grade lymphoma secondary to previously untreated low-grade lymphoma.
  • 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.
  • Patients with a body surface area \>3.0 m2.
  • Major surgery (excluding lymph node biopsy) within 28 days prior to randomization.
  • Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus (HIV) infection or positive test at screening.
  • 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).
  • Positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C serology.
  • Confirmed current active tuberculosis (TB)
  • Central nervous system (CNS) or meningeal involvement, or cord compression by the lymphoma; history of CNS lymphoma
  • History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug (e.g., hypersensitivity or allergy to murine products).
  • Patients who have significant cardiac disease, including but not limited to history of congestive heart failure (New York Heart Association Class III/IV; see Appendix 7), unstable angina, or uncontrolled cardiac arrhythmia.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Research site

Whittier, California, 90603, United States

Location

Research Site

Canberra, Australian Capital Territory, 2605, Australia

Location

Research site

Temuco, Región de la Araucanía, 4810469, Chile

Location

Research site

Hradec Králové, 500 05, Czechia

Location

Research site

Prague, 128 08, Czechia

Location

Reasearch site

Prague, 15000, Czechia

Location

Research site

Libourne, Gironde, 33505, France

Location

Research site

Poitiers, Vienne, 86021, France

Location

Research site

Hamburg, 22081, Germany

Location

Research site

Budapest, 1083, Hungary

Location

Research site

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Research site

Terni, 05100, Italy

Location

Research site

Mexico City, Mexico City, 03720, Mexico

Location

Research site

Pretoria, Gauteng, 0181, South Africa

Location

Research site

Busan, 49241, South Korea

Location

Research site

Seoul, 01757, South Korea

Location

Research site

Seoul, 03080, South Korea

Location

Research site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Research site

Cadiz, 11009, Spain

Location

Research site

Madrid, 28040, Spain

Location

Research site

Ankara, 06340, Turkey (Türkiye)

Location

Research site

Istanbul, 34098, Turkey (Türkiye)

Location

Research site

Mersin, 33343, Turkey (Türkiye)

Location

Research site

Samsun, 55139, Turkey (Türkiye)

Location

Research site

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Medical Director
Organization
Archigen Biotech Ltd
info@archigenbio.com
+44 (0)20 3749 5000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

January 18, 2017

Primary Completion

July 17, 2019

Study Completion

January 10, 2020

Last Updated

October 8, 2020

Results First Posted

October 8, 2020

Record last verified: 2020-09

Locations

CL(1)KR(3)AU(1)FR(2)CZ(3)DE(1)IT(2)TU(4)GB(1)ME(1)ZA(1)HU(1)ES(3)US(1)