Diffuse Large B-cell LymphomaPhase 3ASPIRENCT02054559
R-CHOP Alone vs. R-CHOP Plus Radiotherapy for Localized CD20+ DLBCL
A Phase 3 study testing R-CHOP and Radiotherapy in people with Diffuse Large B-cell Lymphoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To compare the efficacy and safety of chemotherapy alone and combined modality therapy in the treatment of localized CD20 (+) diffuse large B-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- R-CHOP and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento Jan 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Histologically confirmed CD20-positive Diffuse Large B-cell Lymphoma (DLBCL), NOS
- Immunostains for CD20, CD5, CD3, CD10, MUM-1, BCL-6, BCL-2 and Ki-67 and the in situ hybridization for Epstein-Barr virus are recommended for diagnosis of DLBCL, NOS.
- No prior treatment for DLBCL
- Stage I or contiguous II disease (Involvement of two adjacent lymph node regions or organ involvement with regional lymph nodes)
- Performance status: ECOG 0-2.
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- Age ≥ 18 years
- Cardiac ejection fraction ≥ 45% as measured by MUGA or 2D ECHO without clinically significant abnormalities
- Adequate renal function: serum creatinine level < 2 mg/dL
- Adequate liver functions
- Adequate hematological function: hemoglobin ≥ 9.0 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
- Life expectancy >= 6 months
- A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.
- Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device,diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.
Who cannot join
- Other subtypes NHL than CD20 (+) DLBCL, NOS
- Transformed DLBCL from follicular lymphoma or other indolent lymphomas
- Bulky disease ( longest diameter >=10 cm)
- Previous treatment for DLBCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before inclusion
- CNS involvement by lymphoma or any evidence of spinal cord compression.
- Primary Central Nervous System (CNS) DLBCL
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- Primary testicular lymphoma
- Primary breast lymphoma
- Patients with a known history of HIV seropositivity or HCV (+). (Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine, etc) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.)
- Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin, early gastric cancer or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
- Pregnant or lactating women
- Men who are not surgically sterile and women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
- Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- History of significant neurological or psychiatric disorders including dementia or seizures
- Active uncontrolled infection (viral, bacterial or fungal infection)
- Other serious medical illnesses
- Known hypersensitivity to any of the study drugs or its ingredients
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase III Trial Comparing R-CHOP Alone and R-CHOP Plus Radiotherapy for Localized CD20+ Diffuse Large B-cell Lymphoma (DLBCL)
To compare the efficacy and safety of chemotherapy alone and combined modality therapy in the treatment of localized CD20 (+) diffuse large B-cell lymphoma
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- R-CHOP, Radiotherapy
- Keywords
- localized, diffuse large B-cell lymphoma, R-CHOP chemotherapy, radiotherapy
- 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.
R-CHOPDrug
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (or prednisolone))
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Total 6 cycles of R-CHOP | Active comparator | Not described Receives: Drug: R-CHOP |
| Total 3 cycles of R-CHOP + RT | Experimental | Total 3 cycles of R-CHOP followed by radiotherapy (involved field or involved site radiotherapy, 30-50 Gy/ 15-25 fractions) Receives: Drug: R-CHOP; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare 3-year event-free survival
definition of events: failure to achieve CR after completion of planned 1st-line treatment, progression of disease, relapse, institution of a new anticancer treatment or any cause of death) rate in patients with CD20 (+) diffuse large B-cell lymphoma treated with either R-CHOP chemotherapy alone or R-CHOP plus radiotherapy
Measured: 3 years
Secondary outcomes (7)
To evaluate and compare OS between the two arms
Measured: 3 years
To evaluate and compare the ORR and CR rate
Measured: after completion of treatment
To evaluate and compare disease-free survival (DFS)
Measured: 3 years
To evaluate treatment-failure pattern
Measured: 3 years
Number of Participants with Adverse Events in each arm
Measured: 3 years
To assess patient-reported outcomes (PROs) in both arms
Measured: 3 years
A role of interim PET after 3 cycles of R-CHOP chemotherapy: correlation with PFS and OS
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: No consensus among trial centers regarding protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheolwon Suh, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054559
- Sponsor's protocol ID
- AMC_NHL02
- Acronym
- ASPIRE
- Status last verified
- Feb 2016
- First submitted
- 29 Jan 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial Comparing R-CHOP Alone and R-CHOP Plus Radiotherapy for Localized CD20+ Diffuse Large B-cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT02054559
- Acronym / sponsor ID
- ASPIRE / AMC_NHL02
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- localized, diffuse large B-cell lymphoma, R-CHOP chemotherapy, radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No consensus among trial centers regarding protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 4 Feb 2014 (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.
To compare the efficacy and safety of chemotherapy alone and combined modality therapy in the treatment of localized CD20 (+) diffuse large B-cell lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total 6 cycles of R-CHOP | Active comparator | Drug: R-CHOP |
| Total 3 cycles of R-CHOP + RT | Experimental | Drug: R-CHOP, Radiation: RadiotherapyTotal 3 cycles of R-CHOP followed by radiotherapy (involved field or involved site radiotherapy, 30-50 Gy/ 15-25 fractions) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent
- Histologically confirmed CD20-positive Diffuse Large B-cell Lymphoma (DLBCL), NOS
- Immunostains for CD20, CD5, CD3, CD10, MUM-1, BCL-6, BCL-2 and Ki-67 and the in situ hybridization for Epstein-Barr virus are recommended for diagnosis of DLBCL, NOS.
- No prior treatment for DLBCL
- Stage I or contiguous II disease (Involvement of two adjacent lymph node regions or organ involvement with regional lymph nodes)
Key exclusion criteria (19 listed)
- Other subtypes NHL than CD20 (+) DLBCL, NOS
- Transformed DLBCL from follicular lymphoma or other indolent lymphomas
- Bulky disease ( longest diameter >=10 cm)
- Previous treatment for DLBCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before inclusion
- CNS involvement by lymphoma or any evidence of spinal cord compression.
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 |
|---|---|---|
| R-CHOPR-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (or prednisolone)) | Drug | Total 3 cycles of R-CHOP + RT, Total 6 cycles of R-CHOP |
| Radiotherapy | Radiation | Total 3 cycles of R-CHOP + RT |
Primary outcome
To compare 3-year event-free survival
Time frame: 3 years
definition of events: failure to achieve CR after completion of planned 1st-line treatment, progression of disease, relapse, institution of a new anticancer treatment or any cause of death) rate in patients with CD20 (+) diffuse large B-cell lymphoma treated with either R-CHOP chemotherapy alone or R-CHOP plus radiotherapy
7 secondary outcomes
To evaluate and compare OS between the two arms
Time frame: 3 years
To evaluate and compare the ORR and CR rate
Time frame: after completion of treatment
To evaluate and compare disease-free survival (DFS)
Time frame: 3 years
To evaluate treatment-failure pattern
Time frame: 3 years
Number of Participants with Adverse Events in each arm
Time frame: 3 years
To assess patient-reported outcomes (PROs) in both arms
Time frame: 3 years
A role of interim PET after 3 cycles of R-CHOP chemotherapy: correlation with PFS and OS
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing R-CHOP and Radiotherapy 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 14 inclusion and 19 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: withdrawn, as of the sponsor's last update on 23 Feb 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To compare 3-year event-free survival (time frame: 3 years). 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 23 Feb 2016.