Diffuse Large B-cell LymphomaPhase 2NCT02792491
Phase II Prospective Trial of Addition of Rituximab to Reduced Dose CHOP Chemotherapy in DLBC L Patients Aged 65 Years and Over
A Phase 2 study testing Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone in people with Diffuse Large B-cell Lymphoma, run by Pusan National University Hospital.
Trial summary
This is Phase II prospective trial of addition of rituximab to reduced dose CHOP chemotherapy in DLBC L patients aged 65 years and over. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed CD20 positive DLBCL
- Age ≥ 65 years
- Ann Arbor stage II, III and IV
- No prior chemotherapy or radiotherapy for DLBCL
- Performance status (ECOG) ≤ 2
- At least one or more bidimensionally measurable lesion(s)
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- 2 cm by conventional 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 MUGA or 2DECHO without clinically significant abnormalities
- Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L)
- Adequate liver functions:
- Transaminase (AST/ALT) < 3 X upper normal value (or < 5 x ULN in the presence of DLBCL involvement of the liver) Bilirubin < 2 X upper normal value (or < 5 x ULN in the presence of DLBCL involvement of the liver)
- Adequate BM functions: hemoglobin ≥ 9 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 more than 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 < 1years after the onset of menopause.
- Informed consent
Who cannot join
- Other subtypes NHL than DLCBL
- 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. Brain CT/MRI is only mandatory (within 4 weeks) in case of clinical suspicion of CNS involvement by lymphoma. Patients who have only had prophylactic intrathecal chemotherapy against CNS disease are eligible.
- 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) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
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- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions i. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry ii. History of significant neurologic or psychiatric disorders including dementia or seizures iii. Active uncontrolled infection (viral, bacterial or fungal infection) iv. Other serious medical illnesses
- Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
About this study
This is Phase II prospective trial of addition of rituximab to reduced dose CHOP chemotherapy in DLBC L patients aged 65 years and over.
Read the detailed description
The body surface area(BSA) on the date of every treatment cycle may be used as the same value of baseline BSA, if change of body weight is within 10% of baseline body weight. But, if there is a change of body weight more than 10% that of baseline, BSA should be recalculated. It will be repeated every 21 days. But the change of starting date of subsequent cycle and laboratory or radiologic tests may be allowed within 4 days from the scheduled date or delay due to toxicities. The RD-RCHOP treatment will be continued up to 6-8 cycles (or 3 cycles in case of stable disease(SD) or progressive disease(PD) after the first 3cycles) with duration of 21 days. Visit windows ± 4days in Treatment period.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- 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, Cyclophosphamide, Doxorubicin, Vincristine, PrednisoneDrug
Also called R-CHOP
Reduced dose of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
| Study group | Role | What they receive |
|---|---|---|
| Reduced dose R-CHOP | Experimental | Reduced dose R-CHOP is regimen including Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.
In this study, Rituximab 375 mg/m2, Cyclophosphamide 600 mg/m2, Doxorubicin 30 mg/m2 and Vincristine fixed dose of 1mg will be administrated through intravenous on day 1. and Prednisone 40mg will be administrated orally on day 1-5. This chemotherapy will be repeated every 21 days. Receives: Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year progression free survival rate
Measured: Time between the date of treatment start and the date of death due to any cause or date of disease progression, whichever came first, assessed up to 36 months
Secondary outcomes (3)
Overall response rate
Measured: Until the disease progression (maximum 3 years after completion of treatment, assessed up to 36 months(
Overall survival
Measured: Time between the date of treatment start and the date of death due to any cause or date of disease progression, whichever came first, assessed up to 36 months
Toxicity profile
Measured: From the date of first drug administration until the date of the 30th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startAug 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho-Jin Shin, Pusan National University Hospital
- Investigators
- Ho-Jin Ho-Jin, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792491
- Sponsor's protocol ID
- Elderly RD_R-CHOP
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We will share collected data with principal investigators in Korea.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Prospective Trial of Addition of Rituximab to Reduced Dose CHOP Chemotherapy in DLBC L Patients Aged 65 Years and Over
- ClinicalTrials.gov ID
- NCT02792491
- Acronym / sponsor ID
- Elderly RD_R-CHOP
- Conditions
- Diffuse Large B-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Jun 2016 (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.
This is Phase II prospective trial of addition of rituximab to reduced dose CHOP chemotherapy in DLBC L patients aged 65 years and over.
Detailed description
The body surface area(BSA) on the date of every treatment cycle may be used as the same value of baseline BSA, if change of body weight is within 10% of baseline body weight. But, if there is a change of body weight more than 10% that of baseline, BSA should be recalculated. It will be repeated every 21 days. But the change of starting date of subsequent cycle and laboratory or radiologic tests may be allowed within 4 days from the scheduled date or delay due to toxicities. The RD-RCHOP treatment will be continued up to 6-8 cycles (or 3 cycles in case of stable disease(SD) or progressive disease(PD) after the first 3cycles) with duration of 21 days. Visit windows ± 4days in Treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced dose R-CHOP | Experimental | Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, PrednisoneReduced dose R-CHOP is regimen including Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. In this study, Rituximab 375 mg/m2, Cyclophosphamide 600 mg/m2, Doxorubicin 30 mg/m2 and Vincristine fixed dose of 1mg will be administrated through intravenous on day 1. and Prednisone 40mg will be administrated orally on day 1-5. This chemotherapy will be repeated every 21 days. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed CD20 positive DLBCL
- Age ≥ 65 years
- Ann Arbor stage II, III and IV
- No prior chemotherapy or radiotherapy for DLBCL
- Performance status (ECOG) ≤ 2
Key exclusion criteria (10 listed)
- Other subtypes NHL than DLCBL
- 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. Brain CT/MRI is only mandatory (within 4 weeks) in case of clinical suspicion of CNS involvement by lymphoma. Patients who have only had prophylactic intrathecal chemotherapy against CNS disease are eligible.
- 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) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
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 |
|---|---|---|
| Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, PrednisoneAlso: R-CHOPReduced dose of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone | Drug | Reduced dose R-CHOP |
Primary outcome
3 year progression free survival rate
Time frame: Time between the date of treatment start and the date of death due to any cause or date of disease progression, whichever came first, assessed up to 36 months
3 secondary outcomes
Overall response rate
Time frame: Until the disease progression (maximum 3 years after completion of treatment, assessed up to 36 months(
Overall survival
Time frame: Time between the date of treatment start and the date of death due to any cause or date of disease progression, whichever came first, assessed up to 36 months
Toxicity profile
Time frame: From the date of first drug administration until the date of the 30th days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Individual participant dataSharing planned: Yes. We will share collected data with principal investigators in Korea.
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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.
Ho-Jin Ho-Jin principal investigator
Pusan National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone in people with Diffuse Large B-cell Lymphoma, run by Pusan National University Hospital.
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 16 inclusion and 10 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 9 Jun 2016. 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?
3 year progression free survival rate (time frame: Time between the date of treatment start and the date of death due to any cause or date of disease progression, whichever came first, assessed up to 36 months). 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 9 Jun 2016.