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Diffuse Large B-cell LymphomaPhase 2NCT03399747

Abbreviated 3 Cycles of Rituximab Plus CHOP(Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised LocalizedGastrointestinal CD(Cluster of Differentiation Antigen)20(+) Diffuse Large B-cell Lymphoma

A Phase 2 study testing Abb-R-CHOP in people with Diffuse Large B-cell Lymphoma, run by Asan Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Phase 2 Study of Abbreviated 3 Cycles of Rituximab plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients with Completely Excised Localized Gastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma(SATURDAY STUDY) Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Abb-R-CHOP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
7 Dec 2016to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Completely Excised LocalizedGastrointestinal CD20 (+) DLBCL(Diffuse Large B-cell Lymphoma )
  • CD 20, CD5, CD10, MUM-1, BCL-6, BCL-2, Ki-76, EBV(Epstein-Barr virus )positive
  • Lugano Criteria: Stage I, II1
  • Paris Criteria: T1-2NO-1MO
  • Stage-adjusted International Prognostic Index: 0-1
  • A patient who has not previously received chemotherapy or radiation treatment for the DLBCL
Show all 15Show fewer
  • ECOG(Eastern Cooperative Oncology Group ) :0-2
  • In case of patients who do not have any residual lesion due to complete surgical removal of lymphoma I. A patient who has been confirmed to have no residual lesion in the CT conducted following surgery or Ii. Preoperative imaging confirmed as the first phase of a single lesion and post-operative lesion finding that the patient has been confirmed with
  • In case of a 50 % or higher cardiac output when there is no clinically significant abnormality in MUGA(multiple gated acquisition scan) or deep frequency
  • If appropriate renal function (below serum creatinine 2.0 mg dL or an estimated glomerule filtration rate of 40 mL / mill1.73m2 or higher)
  • If the appropriate liver function is present (serum bilirubin), less than three times the normal upper limit of AST(aspartate aminotransferase ) (non-hepatic) unless the serubin is caused by Gilbert syndrome or originated from a non-hepatic ;
  • Proper Bone marrow function (ANC-1500mm 3 or higher, number of platelets > 755mm3, and hemoglobin 9.0 g/L or higher) If the screening in the CS(cerebrospinal fluid)F is not acceptable, the dose is given in - 7
  • For males, blocking contraceptive methods such as condoms are required at least 6 months from the date of the last administration of the cancer and such measures are agreed
  • For fertile women, it must be agreed to apply contraceptive measures (oral contraceptive pills, in the womb, blocking contraceptive methods, etc.) for at least 6 months from the date of administration of the last cancer.
  • decided to participate in this study voluntarily and agree in writing

Who cannot join

  • HIV or HCV(hepatitis C virus) positive patient. However, HBVhepatitis B virus) positive patients using anti-viral therapy are allowed
  • Patient with current history of other cancers (e.g. cervical carcinoma in situ, treated basal cell carcinoma, early cancer, excluded from the present condition of cancer.
  • pregnant or nursing woman, male or female who do not agree with appropriate contraception.
  • Systemic disease that is inappropriate for administration of anticancer drugs I. A patient who within the past 6 months had a clinically significant heart attack (non-medical congestive heart failure, symptomatic coronary artery disease, severe myocardial infarction) or Ii. Serious neurology and psychiatric disease Iii. Serious activity infection Iv. Other medical conditions that are difficult to perform in clinical trials
  • If you are allergic to chemicals used in this study
  • Patients who receive another test medication during a clinical trial or who is administered both chemotherapy, hormone therapy and immunization
  • Patient with Bulky disease (length of diaphragm 10 cm)
  • Patient who is unsuitable for participation in a clinical examination according to the judgment of a researcher

About this study

Official title: Phase 2 Study of Abbreviated 3 Cycles of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised LocalizedGastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma

Phase 2 Study of Abbreviated 3 Cycles of Rituximab plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients with Completely Excised Localized Gastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma(SATURDAY STUDY)

Being tested
Abb-R-CHOP
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abb-R-CHOPDrug

    Completely Excised LocalizedGastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma

    3 Cycles(1 Cycle:4weeks) of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy

Study groups in NCT03399747
Study groupRoleWhat they receive
Abb-R-CHOPExperimentalNot described
Receives: Drug: Abb-R-CHOP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response

    CT(Computed tomography) / PET-CT(Positron emission computed tomography)/ Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO

    Measured: 6 to 8 weeks after completion of the 3rd cycle of treatment(each cycle is 28days)

Secondary outcomes (2)

  1. Assess response rate

    CT/ PET-CT/Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO

    Measured: after completion of the treatment, up to 2years

  2. Assess response rate

    CT/ PET-CT/Colonoscopy(if necessary) by Lugano stage I or II1, Paris stage T1-2NO-1MO

    Measured: after completion of the treatment, up to 4years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2018
  2. Study start7 Dec 2016
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03399747
Sponsor's protocol ID
Asan_LMP2017-002
Status last verified
Jan 2018
First submitted
25 Dec 2017
Last updated
16 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abb-R-CHOP in people with Diffuse Large B-cell Lymphoma, run by Asan Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response (time frame: 6 to 8 weeks after completion of the 3rd cycle of treatment(each cycle is 28days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03399747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.

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