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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

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 54 studies in Lymphoma, Non-Hodgkin by Hoffmann-La Roche — 1 open to participants now, 6 under way, 1 of them phase 3. Lymphoma, Non-Hodgkin · Hoffmann-La Roche.

Started
2017
with 1 other
Observational
5 of 54
none open now
Registered
43rd of 54
by date

Among the 54 studies in Lymphoma, Non-Hodgkin by Hoffmann-La Roche, this one is one of 2 that started in 2017, is one of 5 observational ones, and was the 43rd registered.

Lymphoma, Non-Hodgkin

2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 286 are open to participants now.

Browse Lymphoma, Non-Hodgkin studies →

Open to participants now

1 of the 54 studies in Lymphoma, Non-Hodgkin by Hoffmann-La Roche is open now, in 7 countries. Recruiting first, the newest first:

By country, each count listing its studies:

Who these studies take

Of the 245 Lymphoma, Non-Hodgkin studies recruiting now, 145 (59%) set no upper age limit and 77 (31%) stop at 75 or younger; 68 take children under 18; 10 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Lymphoma, Non-Hodgkin
  • Leukemia, Lymphocytic, Chronic, B-Cell
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

  • 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
  • in use by locally approved indications, dosage, and administration
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

  • 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.

06

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

07

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
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Oct 2020, 37 months.

Of 71 observational studies under Lymphoma, Non-Hodgkin, half reached primary completion within 120 months of starting (the median), counting those still running; a quarter within 37. This study's 37 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2017
First posted
Sep 20, 2017
StartActual
Sep 15, 2017
Primary completionActual
Oct 27, 2020
CompletionActual
Oct 27, 2020
Last update
Jan 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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