Diffuse, Large B-Cell, LymphomaPhase 2NCT00599170
Rituximab Plus CHOP With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Rituximab in people with Diffuse, Large B-Cell, Lymphoma, run by University of Southern California at 1 site in United States.
Trial summary
The use of R-CHOP, given every two weeks, will be associated with improvements in response rate, and progression-free survival, when compared to R-CHOP given every three weeks. The addition of sargramostim will allow safer adminIstration of the dose-intensified R-CHOP, while at the same time, improving the functional… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diffuse, Large B-Cell, Lymphoma
- 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
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2008to 10 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previously untreated, histologically or cytologically documented diffuse large B cell non-Hodgkin's lymphoma.
- Lymphoma must be CD20 positive.
- All stages of disease.
- Measurable or non-measurable tumor parameter(s). Non-measurable tumor parameters will be defined as not having bi-dimensional measurements (i.e. gastric or marrow involvement) but can be followed for response by other diagnostic tests such as gallium, PET imaging and/or bone marrow biopsy.
- Age ≥ 18 years.
- KPS ≥ 50% (ECOG PS 0, 1, or 2).
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- Able to give signed informed consent.
- Adequate hepatic function: bilirubin ≤ 2.0 mg/dl (unless elevated secondary to lymphomatous involvement of liver or biliary system. For bilirubin > 3.0 due to hepatic involvement, the initial dose of doxorubicin will be decreased by 50%, and the initial dose of vincristine will be omitted. SGOT <5X upper limit of normal.
- Adequate renal function: creatinine < 2.0 mg/dl, or creatinine clearance ≥ 60 ml/min, unless secondary to renal involvement by lymphoma.
- Adequate hematologic function: granulocytes (ANC) >1000/mm3, platelets > 75,000/dl, unless these parameters are abnormal secondary to lymphomatous involvement of bone marrow. All patients must be off colony stimulating factor therapy at least 24 hours prior to institution of cycle #1 chemotherapy.
- Left ventricular ejection fraction that is at or above the lower institutional limits of normal, as assessed by nuclear scan or echocardiogram obtained within 6 weeks of registration.
- Concurrent radiation with or without steroids for emergency conditions secondary to lymphoma (i.e. CNS tumor, cord compression, etc) will be permitted, provided that additional, measurable or evaluable sites of lymphomatous disease are present at study entry.
- Female patients must have a negative pregnancy test within 72 hours of entering into the study. Both men and women will be included and, if of child bearing potential, must agree to use adequate contraception for the duration of the treatment. Women must avoid pregnancy and men avoid fathering children while in the study.
- -
Who cannot join
- Presence of second active tumor, other than non melanomatous skin cancer, carcinoma in situ of the cervix.
- Primary central nervous system lymphoma, including parenchymal brain or spinal cord lymphoma.
- Pregnant women or nursing mothers.
- ECOG performance score 3 or more (KPS <50%).
- Expected survival < 3 months.
- Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the principal investigator.
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- Serious, on-going non-malignant disease or infection, which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
- Major surgery, other than diagnostic surgery, within four weeks.
- History of prior therapy with Rituximab within 12 months. Patients treated with Rituximab more than 12 months earlier are eligible only if it was given for indications other than the treatment of aggressive lymphoma.
- History of prior cytotoxic chemotherapy or radiotherapy for this lymphoma.
- History of cutaneous or muco-cutaneous reactions or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for 2 days or more. This exclusion relates to the long-term possibility of severe muco-cutaneous or cutaneous reactions to Rituximab, which maybe occurred at increased frequency in patients who have had severe skin disease or reactions in the past.
- Any acute inter-current infection that may interfere with planned protocol treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089
About this study
Official title: Rituximab Plus CHOP Given Every Two Weeks With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
The use of R-CHOP, given every two weeks, will be associated with improvements in response rate, and progression-free survival, when compared to R-CHOP given every three weeks. The addition of sargramostim will allow safer adminIstration of the dose-intensified R-CHOP, while at the same time, improving the functional capability of the macrophages, and thus increasing the likelihood of improved clinical response and disease-free survival.
The current phase II study is being proposed in order to develop preliminary data on the efficacy and toxicity of this approach, for future study in larger, phase III randomized trials. Laboratory correlates of response will also be studied, including activation markers on monocytes/macrophages before and after sargramostim exposure; and presence or absence of informative Fc gamma III polymorphisms.
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Being tested
- Rituximab
- Keywords
- This is a standard phase II trial, in which patients with newly diagnosed diffuse large B cell lymphoma will receive R-CHOP with GM-CSF
- 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
375 mg/m2 IV
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Rituximab 375 mg/m2 iv on day 1 q 15 days just prior to CHOP, beginning with cycle 1. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in this trial will be tumor complete response (CR, CRu) to R-CHOP + GM-CSF, given every 14 days
Measured: Every 2 cycles
Secondary outcomes (1)
Response duration
Measured: Every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study start10 Jan 2008
- Primary completion10 Jan 2020
- Study completion10 Jan 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.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anil Tulpule, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599170
- Sponsor's protocol ID
- 13nhl-07-3
- Status last verified
- Nov 2021
- First submitted
- 11 Jan 2008
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab Plus CHOP Given Every Two Weeks With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00599170
- Acronym / sponsor ID
- 13nhl-07-3
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Keywords
- This is a standard phase II trial, in which patients with newly diagnosed diffuse large B cell lymphoma will receive R-CHOP with GM-CSF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 10 Jan 2008 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 23 Jan 2008 (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.
The use of R-CHOP, given every two weeks, will be associated with improvements in response rate, and progression-free survival, when compared to R-CHOP given every three weeks. The addition of sargramostim will allow safer adminIstration of the dose-intensified R-CHOP, while at the same time, improving the functional capability of the macrophages, and thus increasing the likelihood of improved clinical response and disease-free survival.
The current phase II study is being proposed in order to develop preliminary data on the efficacy and toxicity of this approach, for future study in larger, phase III randomized trials. Laboratory correlates of response will also be studied, including activation markers on monocytes/macrophages before and after sargramostim exposure; and presence or absence of informative Fc gamma III polymorphisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: RituximabRituximab 375 mg/m2 iv on day 1 q 15 days just prior to CHOP, beginning with cycle 1. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Previously untreated, histologically or cytologically documented diffuse large B cell non-Hodgkin's lymphoma.
- Lymphoma must be CD20 positive.
- All stages of disease.
- Measurable or non-measurable tumor parameter(s). Non-measurable tumor parameters will be defined as not having bi-dimensional measurements (i.e. gastric or marrow involvement) but can be followed for response by other diagnostic tests such as gallium, PET imaging and/or bone marrow biopsy.
- Age ≥ 18 years.
Key exclusion criteria (12 listed)
- Presence of second active tumor, other than non melanomatous skin cancer, carcinoma in situ of the cervix.
- Primary central nervous system lymphoma, including parenchymal brain or spinal cord lymphoma.
- Pregnant women or nursing mothers.
- ECOG performance score 3 or more (KPS <50%).
- Expected survival < 3 months.
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 |
|---|---|---|
| Rituximab375 mg/m2 IV | Drug | Arm 1 |
Primary outcome
The primary endpoint in this trial will be tumor complete response (CR, CRu) to R-CHOP + GM-CSF, given every 14 days
Time frame: Every 2 cycles
1 secondary outcome
Response duration
Time frame: Every 2 cycles
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 17 Nov 2021.
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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.
Anil Tulpule, MD principal investigator
University of Southern California
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 Diffuse, Large B-Cell, Lymphoma, run by University of Southern California at 1 site in United States.
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 12 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 17 Nov 2021. 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 United States. 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?
The primary endpoint in this trial will be tumor complete response (CR, CRu) to R-CHOP + GM-CSF, given every 14 days (time frame: Every 2 cycles). 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 17 Nov 2021.