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CompletedNCT03289182Updated Jan 11, 2021

An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)

An observational study in Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Hoffmann-La Roche. Completed at 25 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-01-11.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
701
Ages
19 Years and older
Sex
All
01

Study summary

This is a prospective, multicenter, non-interventional study to test the safety and effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The length of study is expected to be 6 years.

02

Conditions studied

  • Lymphoma, Non-Hodgkin
  • Leukemia, Lymphocytic, Chronic, B-Cell
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Participants receiving treatment for NHL or CLL with MabThera SC under observation according to standard of care and in line with the current local labelling in Korea.

Inclusion criteria

  • Participants administered with MabThera subcutaneously within the approved indication in Korea
  • Participants previously untreated with MabThera subcutaneously

Inclusion Criteria for NHL participants for MabThera subcutaneously 1400mg:

  • Relapsed or chemoresistant follicular lymphoma (FL) (B, C, and D type by international working formulation classification of B-cell NHL) participants
  • Previously untreated FL participants in combination with chemotherapy
  • Participants who are treated with maintenance therapy after the treatment of FL participants responding to induction therapy.
  • Cluster of differentiation 20-positive, diffuse large B-cell NHL participants in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (8 cycles) chemotherapy

Inclusion Criteria for CLL participants for MabThera subcutaneously 1600mg:

  • Previously untreated or relapsed/refractory CLL participants in combination with chemotherapy

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Participants who are out of locally approved indications, dosage, and administration including medication error
  • Contraindication in use by locally approved indications, dosage, and administration
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
701 participants (actual)
Patient registry
No

Groups and cohorts

  • MabThera

    Participants with NHL will be administered 1400 milligrams (mg) and those with with CLL will be administered 1600 mg MabThera subcutaneously at the discretion of the physician in accordance with local clinical practice and local labeling, and will be observed for 6 years.

    Drug: MabThera

Interventions

  • DrugMabThera

    Participants will be administered MabThera 1400 mg (NHL) or 1600 mg (CLL) at the discretion of the physician in accordance with local clinical practice and local labeling.

05

What researchers measure

Primary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: Baseline up to Year 6

Secondary outcomes

  1. Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL

    Time frame: Baseline up to Year 6

  2. Percentage of Participants with Overall Response as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria

    Time frame: Baseline up to Year 6

06

Study locations

25 sites
  • Soon Chun Hyang University Hospital Bucheon
    Bucheon-si,, 420-767, Korea, Republic of
  • Inje University Busan Paik Hospital
    Busan, 47392, Korea, Republic of
  • Pusan National University Hospital
    Busan, 49241, Korea, Republic of
  • Keimyung University Dongsan Medical Center
    Daegu, 41931, Korea, Republic of
  • Yeungnam University Medical Center
    Daegu, 42415, Korea, Republic of
  • Daegu Catholic University Medical Center; Hematology
    Daegu, Korea, Republic of
  • Chungnam National University Hospital
    Daejeon, 35015, Korea, Republic of
  • Korea University Ansan Hospital
    Gyeonggi-do, 15355, Korea, Republic of
  • St. Vincent's Hospital
    Gyeonggi-do, 16247, Korea, Republic of
  • Hallym University Sacred Heart Hospital; Department of Hematology
    Gyeonggi-do, 431-070, Korea, Republic of
  • Pusan National University Yangsan Hospital
    Gyeongsangnam-do, 50612, Korea, Republic of
  • Gachon University Gil Medical Center
    Incheon, 21565, Korea, Republic of
  • Chonnam National University Hwasun Hospital
    Jeollanam-do, 58128, Korea, Republic of
  • Inje University, Sanggye-Paik Hospital
    Seoul, 01757, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, 02841, Korea, Republic of
  • Kangbuk Samsung Hospital
    Seoul, 03181, Korea, Republic of
  • Ewha Womans University Mokdong Hospital
    Seoul, 07985, Korea, Republic of
  • Seoul National University Hospital; Department of Oncology
    Seoul, 110-744, Korea, Republic of
  • Severance Hospital, Yonsei University Health System; Oncology
    Seoul, 120-752, Korea, Republic of
  • Samsung Medical Centre; Division of Hematology/Oncology
    Seoul, 135-710, Korea, Republic of
  • St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
    Seoul, 137-701, Korea, Republic of
  • Korea Cancer Center Hospital; Surgery
    Seoul, 139-709, Korea, Republic of
  • Korea University Guro Hospital; Department of Hematology & Oncology
    Seoul, 152-703, Korea, Republic of
  • SMG-SNU Boramae Medical Center
    Seoul, 156-707, Korea, Republic of
  • Ulsan University Hosiptal
    Ulsan, 44033, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03289182
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 20, 2017
Start date
Sep 15, 2017
Primary completion
Oct 27, 2020
Completion
Oct 27, 2020
Last update
Jan 11, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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