Diffuse Large B Cell LymphomaPhase 2NCT03465527
Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL
A Phase 2 study testing PrednisoLONE 50 MG in people with Diffuse Large B Cell Lymphoma, run by Kosin University Gospel Hospital at 1 site in South Korea.
Trial summary
A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- PrednisoLONE 50 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Apr 2017to 13 Jul 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically the first large-scaled B-cell lymphoma patient
- Diagnosis time 65 years old or older
- Patients planning R-CHOP chemotherapy
- Ann Arbor stage 2 (bulky ≥ diameter of 7cm), stage 3 or stage 4
- The International Prognostic Index (IPI) is a high intermediate or high risk
- Patients without prior history of lymphoma
- The decision to participate voluntarily in this study and the written consent of the patient
Who cannot join
- Histologic subtypes other than CD20 positive broad-band macro-B cell lymphoma
- Large B-cell lymphoma involving the central nervous system
- Inadequate systemic disease A. Patients with clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia) or myocardial infarction within the past 6 months B. Serious neurological and psychiatric illness C. Serious active infection D. Other medical illnesses other than clinical trials
- If the drug used in this study is allergic
- If you do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Trial of Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL
A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL
Read the detailed description
R-CHOP Chemotherapy Cataract treatment with anterior steroids Phenotypic effects Evaluate the felony associated with the procedure for the primary purpose. This study evaluated efficacy, treatment outcome and safety for all patients.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- PrednisoLONE 50 MG
- 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.
PrednisoLONE 50 MGDrug
Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Experimental | Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days
Hydration, antibiotics, allopurinol, nutritional supplements, and so on. Receives: Drug: PrednisoLONE 50 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
(treatment-related mortality rate; TRM)
treatment-related mortality rate
Measured: an average of 1 year
Secondary outcomes (5)
IMWG fragility score before and after pre-phase treatment
International Myeloma Working Group,( IMWG)
Measured: an average of 1 year
TRM and RR according to IMWG fragility score
International Myeloma Working Group,( IMWG)
Measured: an average of 1 year
response rate; RR
response rate
Measured: an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
safety
Measured: an average of 1 year
Incidence of neutropenic fever
Incidence of neutropenic fever
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start13 Apr 2017
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kosin University Gospel Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Sup Lee, Kosin University Gospel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465527
- Sponsor's protocol ID
- Prephase
- Status last verified
- Mar 2022
- First submitted
- 8 Jan 2018
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL
- ClinicalTrials.gov ID
- NCT03465527
- Acronym / sponsor ID
- Prephase
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Kosin University Gospel HospitalUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 14 Mar 2018 (actual)
- 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.
A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL
Detailed description
R-CHOP Chemotherapy Cataract treatment with anterior steroids Phenotypic effects Evaluate the felony associated with the procedure for the primary purpose. This study evaluated efficacy, treatment outcome and safety for all patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Experimental | Drug: PrednisoLONE 50 MGPrednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days Hydration, antibiotics, allopurinol, nutritional supplements, and so on. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Histologically the first large-scaled B-cell lymphoma patient
- Diagnosis time 65 years old or older
- Patients planning R-CHOP chemotherapy
- Ann Arbor stage 2 (bulky ≥ diameter of 7cm), stage 3 or stage 4
- The International Prognostic Index (IPI) is a high intermediate or high risk
Key exclusion criteria (5 listed)
- Histologic subtypes other than CD20 positive broad-band macro-B cell lymphoma
- Large B-cell lymphoma involving the central nervous system
- Inadequate systemic disease A. Patients with clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia) or myocardial infarction within the past 6 months B. Serious neurological and psychiatric illness C. Serious active infection D. Other medical illnesses other than clinical trials
- If the drug used in this study is allergic
- If you do not agree to participate in the study
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 |
|---|---|---|
| PrednisoLONE 50 MGPrednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days | Drug | Prednisolone |
Primary outcome
(treatment-related mortality rate; TRM)
Time frame: an average of 1 year
treatment-related mortality rate
5 secondary outcomes
IMWG fragility score before and after pre-phase treatment
Time frame: an average of 1 year
TRM and RR according to IMWG fragility score
Time frame: an average of 1 year
response rate; RR
Time frame: an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: an average of 1 year
Incidence of neutropenic fever
Time frame: an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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 2 study testing PrednisoLONE 50 MG in people with Diffuse Large B Cell Lymphoma, run by Kosin University Gospel 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 1 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
(treatment-related mortality rate; TRM) (time frame: an average of 1 year). 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 1 Apr 2022.