Lymphoma, Large B-cell, DiffusePhase 2NCT01181999
Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma
A Phase 2 study testing rituximab in people with Lymphoma, Large B-cell, Diffuse, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Lymphoma, Large B-cell, Diffuse
- What is being tested?
- rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Sep 2014
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed CD20 positive DLBCL
- Age ≥ 70
- Ann Arbor stage II, III and IV
- No prior chemotherapy or radiotherapy for DLBCL
- Performance status (Eastern Cooperative Oncology Group) ≤ 2
- At least one or more bidimensionally measurable lesion(s)
Show all 17Show fewer
- ≥ 2 cm by conventional computerized tomography (CT)
- ≥ 1 cm by spiral CT
- skin lesion (photographs should be taken) ≥ 2 cm
- measurable lesion by physical examination ≥ 2 cm
- Cardiac ejection fraction ≥ 50% as measured by echocardiogram without clinically significant abnormalities
- Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L)
- Adequate liver functions:
- Adequate bone marrow functions:
- hemoglobin ≥ 9 g/dL absolute neutrophil count ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
- Life expectancy more than 6 months
- Informed consent
Who cannot join
- Other subtypes of non-Hodgkin's lymphoma
- Patients who transformed follicular lymphoma or other indolent lymphoma
- Primary Central Nervous System (CNS) DLBCL
- CNS involvement by lymphoma or any evidence of spinal cord compression.
- Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+).
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chonnam National University Hwasun Hosptial
Jeollanam-do, 519-809
Deok-Hwan Yang, M.D. and Ph.D., 82-61-3797636, drydh1685@gmail.com
So-Young Lee, Nurse, 82-61-3768090, kaosin@naver.com
About this study
Official title: Phase II Trial of Rituximab (R) Augmentation Following R-CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone) Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma (DLBCL)
Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL).
The study is aimed to evaluate the overall response rate and the safety of four cycles of R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed DLBCL patients with aged more than 70 years.
Read the detailed description
- Four cycles of R-CHOP chemotherapy for the induction treatment [Dose intensity of CHOP chemotherapy is modulated according to Charlson Comorbidity Index (CCI)] If patients with CCI <1
- Rituximab: 375 mg/m2, day 1 every 3 weeks.
- Conventional dose of CHOP chemotherapy repeat every 3 weeks. If patients with CCI ≥1
- Rituximab: 375 mg/m2, day 1 every 3 weeks.
- 75% of conventional CHOP repeat every 3 weeks.
- Rituximab augmentation
- Rituximab: 375 mg/m2, every week x 4 times.
- Trimethoprim-sulfamethoxazole 1 tablet per day during augmentation
- Conditions
- Lymphoma, Large B-cell, Diffuse
- Being tested
- rituximab
- Keywords
- diffuse large B-cell lymphoma, elderly patients, rituximab augmentation
- 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.
rituximabDrug
A dose of 375mg/m2 rituximab will be administered intravenously on day 1 of first to fourth R-CHOP chemotherapy and on day 1, 8, 15, 22 of each augmentation chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| rituximab | Experimental | Not described Receives: Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
the overall response rate
To evaluate the objective overall response rate of four cycles of R-CHOP and followed by four times weekly rituximab augmentation in exteremely elderly patients with DLBCL.
Measured: three years after the completion of rituximab augmentation
Number of patients with adverse events
All patients will be evaluated for the toxicity during the treatment. Toxicity is graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC v3.0).
Measured: three years
Secondary outcomes (1)
progression-free survival
Measured: Three years after the completion of rituximab augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2012 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-cell, DiffuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Asan Medical Center, Severance Hospital
- Responsible party
- Principal investigator, Deok-Hwan Yang, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181999
- Sponsor's protocol ID
- ML25393
- Status last verified
- Jul 2010
- First submitted
- 11 Aug 2010
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Rituximab (R) Augmentation Following R-CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone) Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT01181999
- Acronym / sponsor ID
- ML25393
- Conditions
- Lymphoma, Large B-cell, Diffuse
- Keywords
- diffuse large B-cell lymphoma, elderly patients, rituximab augmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Asan Medical Center, Severance Hospital
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 16 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL).
The study is aimed to evaluate the overall response rate and the safety of four cycles of R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed DLBCL patients with aged more than 70 years.
Detailed description
- Four cycles of R-CHOP chemotherapy for the induction treatment [Dose intensity of CHOP chemotherapy is modulated according to Charlson Comorbidity Index (CCI)] If patients with CCI <1
- Rituximab: 375 mg/m2, day 1 every 3 weeks.
- Conventional dose of CHOP chemotherapy repeat every 3 weeks. If patients with CCI ≥1
- Rituximab: 375 mg/m2, day 1 every 3 weeks.
- 75% of conventional CHOP repeat every 3 weeks.
- Rituximab augmentation
- Rituximab: 375 mg/m2, every week x 4 times.
- Trimethoprim-sulfamethoxazole 1 tablet per day during augmentation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab | Experimental | Drug: rituximab |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed CD20 positive DLBCL
- Age ≥ 70
- Ann Arbor stage II, III and IV
- No prior chemotherapy or radiotherapy for DLBCL
- Performance status (Eastern Cooperative Oncology Group) ≤ 2
Key exclusion criteria (8 listed)
- Other subtypes of non-Hodgkin's lymphoma
- Patients who transformed follicular lymphoma or other indolent lymphoma
- Primary Central Nervous System (CNS) DLBCL
- CNS involvement by lymphoma or any evidence of spinal cord compression.
- Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximabA dose of 375mg/m2 rituximab will be administered intravenously on day 1 of first to fourth R-CHOP chemotherapy and on day 1, 8, 15, 22 of each augmentation chemotherapy. | Drug | rituximab |
Primary outcome
the overall response rate
Time frame: three years after the completion of rituximab augmentation
To evaluate the objective overall response rate of four cycles of R-CHOP and followed by four times weekly rituximab augmentation in exteremely elderly patients with DLBCL.
Number of patients with adverse events
Time frame: three years
All patients will be evaluated for the toxicity during the treatment. Toxicity is graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC v3.0).
1 secondary outcome
progression-free survival
Time frame: Three years after the completion of rituximab augmentation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab in people with Lymphoma, Large B-cell, Diffuse, run by Chonnam National University Hospital 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 17 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 22 Sep 2011. 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?
Contact Deok-Hwan Yang, M.D. and Ph.D. (82-61-379-7636, drydh1685@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the overall response rate (time frame: three years after the completion of rituximab augmentation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2011.