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Diffuse Large B-cell LymphomaPhase 2NCT01279902

Abbreviated R-CHOP in Completely Excised Stage I or II DLBCL

A Phase 2 study testing Rituximab plus CHOP Immunochemotherapy in people with Diffuse Large B-cell Lymphoma, run by Asan Medical Center at 1 site in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study aims; to assess the efficacy of shortened systemic chemotherapy in patients with completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage I or II. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Rituximab plus CHOP Immunochemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSouth Korea
Study dates
Aug 2010to Jan 2017
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who underwent curative resection of primary tumor
  • Pathologically confirmed CD20 positive diffuse large B-cell lymphoma (DLBCL) after surgical resection
  • Ann Arbor Stage I or II
  • No history of chemotherapy
  • Performance status: ECOG 0-2
  • Age: 18 to 70 years old
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  • Complete excision with negative resection margin on pathologic report after surgery
  • Cardiac ejection fraction ≥ 50% as measured by MUGA or 2D echocardiography without clinically significant abnormalities
  • Adequate renal function: serum creatinine level below 2 mg/dL (177μmol/L)
  • Adequate liver functions: Transaminase (AST/ALT) < 3X upper normal value, Bilirubin < 2X upper normal value
  • Adequate hematologic function: hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500/mm3 and platelet count ≥ 75,000/mm3
  • Informed consent

Who cannot join

  • Patients with a known history of HIV (+) or HCV (+). However, HBV(+) patients are eligible if primary prophylaxis is given
  • Previous or concurrent cancer that is distinct in primary site or histology from DLBCL, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated > 3 years prior to entry is permitted
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • Other serious illness or medical conditions
  • Unstable cardiac disease (i.e. congestive heart failure, arrhythmia symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry
  • History of significant neurological or psychiatric disorders including dementia or seizures
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  • Active uncontrolled infection (viral, bacterial or fungal infection)
  • Other serious medical illnesses
  • Known hypersensitivity to any of the study drugs or their ingredients
  • Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
  • Patient with B symptoms or Bulky disease

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

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 Stage I or II CD20+ Diffuse Large B-cell Lymphoma

This study aims; to assess the efficacy of shortened systemic chemotherapy in patients with completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage I or II.

Read the detailed description

Unlike the limited stage diffuse Large B-cell Lymphoma (DLBCL) treated with primary chemotherapy followed by radiotherapy, patients with stage I or II DLBCL would be treated with surgical resection followed by chemotherapy in this trial. While chemotherapy is the main treatment modality and radiotherapy becomes adjuvant treatment in the former treatment scheme, surgical resection will remove all the gross lesions and chemotherapy aims to remove all microscopic disease whichever exists in the latter treatment scheme. Currently, six cycles of chemotherapy is usually performed after surgery even without any residual lesion compared with three cycles of chemotherapy in the former treatment scheme which plays primary role in the treatment scheme. The investigators will investigate whether abbreviated 3 cycles of Rituximab Plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone (R-CHOP) immunochemotherapy following complete resection is an effective and safe treatment.

Being tested
Rituximab plus CHOP Immunochemotherapy
Keywords
diffuse large B-cell lymphoma, rituximab, CHOP, abbreviated therapy
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.

  • Rituximab plus CHOP ImmunochemotherapyDrug

    The R-CHOP treatment will continue up to 3 cycles with interval of 21 days: Each cycle consists of rituximab 375mg/m2 (iv, on day 1), cyclophosphamide 750 mg/m2 (iv, on day 1), doxorubicin 50mg/m2 (iv, on day 1), vincristine 1.4mg/m2 (iv, on day 1), and prednisolone 100mg (po, on day 1-5).

Study groups in NCT01279902
Study groupRoleWhat they receive
Rituximab plus CHOP ImmunochemotherapyExperimentalInterventions: conventional R-CHOP every 3 weeks for 3 cycles * Rituximab 375 mg/M2 IV day 1 * Cyclophosphamide 750 mg/M2 IV day1 * Vincristine 1.5 mg/M2 (max. 2 mg) IV day1 * Prednisolone 50 mg bid day 1-5, every 3 weeks
Receives: Drug: Rituximab plus CHOP Immunochemotherapy

What is being measured

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

  1. Disease-free survival

    Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relapse of DLBCL

    Measured: 2 years

Secondary outcomes (2)

  1. Overall survival

    proportion of patients surviving at 2 year after first cycle of R-CHOP chemotherapy regardless of relapse of DLBCL

    Measured: 2 years

  2. any adverse events as a measure of safety and tolerability

    The number of patients with adverse events will be measured during R-CHOP chemotherapy according to CTCAE version 3.0.

    Measured: from the first R-CHOP to 1 month after completion of R-CHOP

Timeline

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

  1. First posted20 Jan 2011 (estimated)
  2. Study startAug 2010
  3. Primary completionAug 2016 (estimated)
  4. Study completionJan 2017 (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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01279902
Sponsor's protocol ID
AMC_NHL01
Status last verified
Jul 2016
First submitted
3 Aug 2010
Last updated
26 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Kang S, Cho H, Sohn BS, Oh SY, Lee WS, Lee SM, Yang DH, Huh J, Yoon DH, Suh C. Long-term follow-up of abbreviated R-CHOP chemoimmunotherapy for completely resected limited-stage diffuse large B cell lymphoma (CISL 12-09). Ann Hematol. 2020 Dec;99(12):2831-2836. doi: 10.1007/s00277-020-04284-z. Epub 2020 Sep 28.

    PubMed 32989495

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab plus CHOP Immunochemotherapy in people with Diffuse Large B-cell Lymphoma, run by Asan Medical Center at 1 site in South Korea.

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 12 inclusion and 11 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 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Disease-free survival (time frame: 2 years). 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 NCT01279902, which also lists 1 linked publication.

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 26 Jul 2016.

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