Non-Hodgkins LymphomaNCT00574730
CHOP/Rituximab Followed by Maintenance PEG Intron in Treatment of Indolent/Follicular Non-Hodgkin's Lymphoma
A study testing CHOP/Rituximab and PEG INTRON in people with Non-Hodgkins Lymphoma, run by University of Nebraska at 1 site in United States.
Trial summary
This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Non-Hodgkins Lymphoma
- What is being tested?
- CHOP/Rituximab and PEG INTRON
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2001to 7 Jun 2012
- Phase
- Interventional
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of advanced stage indolent non-Hodgkin's lymphoma expressing the CD20 surface antigen (as measured by immunohistochemistry or flow cytometry on peripheral blood, marrow, or tumor tissue). Specific histologic subtypes which are eligible include follicular small cleaved cell (follicular grade 1) and follicular mixed small cleaved and large cell (follicular grade 2) lymphoma, and small lymphocytic lymphoma. Patients with indolent follicular lymphoma (follicular grades 1 and with areas of diffuse histology and patients with diffuse follicle center cell lymphoma are eligible as long as the diffuse areas are not felt to represent areas of transformation to diffuse large B-cell lymphoma.
- Patients with bulky stage II (at least one tumor mass >/= 5 cm), or stage III or stage IV disease.
- Patients with an expected life expectancy of at least 18 months.
- Karnofsky Performance Status >70 (ECOG 0, 1)
- No prior anthracycline/anthracenedione-based chemotherapy (e.g., CHOP, CNOP)
- No prior chemotherapy, immunotherapy, radiotherapy, or investigational therapies within three weeks of study entry. Steroid therapy is allowed only if required for maintenance of another chronic disease (e.g., rheumatoid arthritis)
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- Patients with newly diagnosed, relapsed, or refractory disease are eligible as long as they have symptoms or signs which require treatment in the opinion of the treating physician.
- Patients must have at least one bi-dimensionally measurable lesion.
- Patients aged > 60 years, or patients with a history of coronary artery disease, congestive heart failure, hypertension, diabetes, or hyperlipidemia must have an estimated ejection fraction > 0.45 (45%) by MUGA or echocardiography, performed within two months of study entry.
- Females of childbearing potential must have a negative serum pregnancy test prior to enrollment in the study.
- Patients without evidence of severe organ dysfunction as determined within two weeks of study entry:
- Hemoglobin > 8 g/dl; Absolute neutrophil count > 1000/; platelets > 100,000 Creatinine < 2.0 mg/dl, Bilirubin < 2.0 mg/dl; AST < 3 x upper normal; ALP < 3 x upper normal (if liver function abnormalities are felt to be due to hepatic involvement by lymphoma, bilirubin < 6 mg/dl; AST < 4 x upper normal; ALP < 4 x upper normal will be accepted).
- All patients will have a complete eye examination performed by an ophthalmologist at baseline.
- 14. Patients with negative HBSAg are eligible. In the absence of HBSAg negative results, the following will apply:
- Patients with positive HBSAg must be further evaluated for potential risk of hepatitis B reactivation (see baseline evaluations). If it is felt that the benefits of rituximab-based therapy outweigh the risks of Hepatitis B reactivation, the patient may be enrolled at the discretion of the investigator and will be referred to gastroenterology for evaluation and possible prophylactic therapy (see baseline evaluations)
- If the patient requires immediate treatment prior to determination of HBSAg results, and the risk of lymphoma outweighs the potential risk of hepatitis B reactivation, the patient may be enrolled at the discretion of the investigator.
Who cannot join
- Active CNS lymphoma.
- Uncontrolled/poorly controlled serious nonmalignant disease (e.g., uncontrolled diabetes mellitus, hypertension, angina, chronic obstructive pulmonary disease).
- History of hypersensitivity to interferon-alpha.
- Active uncontrolled infection.
- History of any other malignancy (except for treated squamous cell or basal cell carcinoma of the skin, or cervical intra-epithelial neoplasia of the cervix) within the past five years.
- New York Heart Association class III or IV heart disease
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- Myocardial infarction within the past six months.
- Major surgery within the past month.
- Diagnosis of deep vein thrombosis or pulmonary embolism within the past three months.
- Females who are pregnant or lactating.
- Females of childbearing age who are unwilling to use appropriate methods of contraception.
- Active psychiatric conditions (e.g., untreated severe depression or psychosis).
- Patients with known HIV infection.
- Patients who are on another protocol involving non-FDA approved biologics or drugs.
- Vulnerable subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: CHOP/Rituximab Followed by Maintenance Pegylated Interferon-Alpha (PEG Intron)With the Treatment of Patients With Anthracycline Naïve Indolent/Follicular Non-Hodgkin's Lymphoma
This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression, molecular response, and immunologic parameters related to this treatment.will have an ocular exam prior to treatment.
Patients in this study will receive 6 cycles of combination chemotherapy with the standard CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for six to eight cycles. Patients achieving at least a partial response to chemotherapy will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be continued for 12 months in the absence of signs of progressive/recurrent disease, or unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on the presence of symptoms or other clinical manifestations of toxicity. Patients will undergo bone marrow evaluation for molecular testing at baseline. Those found to be positive will have repeat assessments performed post induction therapy, and after six months of PEG Intron. Patients will also undergo immunologic evaluation at baseline, post induction therapy, and after six months of PEG Intron. At the end of PEG Intron therapy, patients will have disease reevaluation and then annual data collection for long-term toxicity, duration of response and survival.
Read the detailed description
This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression, molecular response, and immunologic parameters related to this treatment. Adult patients with indolent, advanced stage, anthracycline naive NHL requiring treatment may be eligible. Patients must have measurable disease, no severe organ dysfunction, and normal ejection fraction in older patients. Patients also must have adequate hematologic, hepatic and renal function, performance status, and life expectancy of at least 18 months. Patients may not have CNS lymphoma, uncontrolled co-morbid conditions, pregnancy, HIV, and active psychiatric conditions. Additionally, patients may not have had prior hypersensitivity to interferon-alpha, other cancer within 5 years, significant heart disease or myocardial infarction within the last 6 months, and history of thrombosis. Additionally, patients will have an ocular exam prior to treatment.
Patients in this study will receive 6 cycles of combination chemotherapy with the standard CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for six to eight cycles. Patients achieving at least a partial response to chemotherapy will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be continued for 12 months in the absence of signs of progressive/recurrent disease, or unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on the presence of symptoms or other clinical manifestations of toxicity. Patients will undergo bone marrow evaluation for molecular testing at baseline. Those found to be positive will have repeat assessments performed post induction therapy, and after six months of PEG Intron. Patients will also undergo immunologic evaluation at baseline, post induction therapy, and after six months of PEG Intron. At the end of PEG Intron therapy, patients will have disease reevaluation and then annual data collection for long-term toxicity, duration of response and survival.
- Conditions
- Non-Hodgkins Lymphoma
- Being tested
- CHOP/Rituximab, PEG INTRON
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOP/RituximabDrug
Six cycles of CHOP/Rituximab therapy at 21-day intervals. CHOP chemo will be administered on day 1 after rituximab.
Cyclophosphamide750mg/m2 IV, Doxorubicin 50mg/m2 IV, Vincristine 1.4mg/m2 (max 2mg) IV, Prednisone 100mg PO daily x 5 days Rituximab 375mg/m2
PEG INTRONDrug
Pegylated Interferon-alpha 2mg/kg/week for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will receive 6 cycles of combination chemotherapy with the standard CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for six to eight cycles. Participants achieving at least a partial response to chemotherapy will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be continued for 12 months in the absence of signs of progressive/recurrent disease, or unacceptable toxicity/intolerance of therapy. Receives: Drug: CHOP/Rituximab; Drug: PEG INTRON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Failure/Duration of Response/Time to Treatment Failure/Survival
Treatment failure: registration to treatment discontinuation/withdrawal for progression, death, AE, etc. Progression: registration to progression. Duration of response: evaluation with a CR, CCR or PR to progression. Time to death: registration to death.
Measured: Treatment failure: registration to treatment discontinuation/withdrawal for progression, death, AE, etc. Progression: registration to progression. Duration of response: evaluation with a CR, CCR or PR to progression. Time to death: registration to death.
Secondary outcomes (1)
Biologic/Immunologic Evaluation
Patients with follicular NHL will undergo bone marrow evaluation for the presence of the bcl-2 gene rearrangement at baseline. Those found to be positive will have repeat assessments performed post induction therapy and after six months of PEG Intron.
Measured: Baseline, post induction therapy and after six months of PEG-Intron.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study start23 May 2001
- Primary completion1 Aug 2005
- Study completion7 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkins LymphomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Robert G Bociek, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574730
- Sponsor's protocol ID
- 0013-01-FB
- Status last verified
- Sep 2023
- First submitted
- 12 Dec 2007
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOP/Rituximab Followed by Maintenance Pegylated Interferon-Alpha (PEG Intron)With the Treatment of Patients With Anthracycline Naïve Indolent/Follicular Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00574730
- Acronym / sponsor ID
- 0013-01-FB
- Conditions
- Non-Hodgkins Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- 23 May 2001 (actual)
- Primary completion
- 1 Aug 2005 (actual)
- Study completion
- 7 Jun 2012 (actual)
- First posted
- 17 Dec 2007 (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 study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression, molecular response, and immunologic parameters related to this treatment.will have an ocular exam prior to treatment.
Patients in this study will receive 6 cycles of combination chemotherapy with the standard CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for six to eight cycles. Patients achieving at least a partial response to chemotherapy will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be continued for 12 months in the absence of signs of progressive/recurrent disease, or unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on the presence of symptoms or other clinical manifestations of toxicity. Patients will undergo bone marrow evaluation for molecular testing at baseline. Those found to be positive will have repeat assessments performed post induction therapy, and after six months of PEG Intron. Patients will also undergo immunologic evaluation at baseline, post induction therapy, and after six months of PEG Intron. At the end of PEG Intron therapy, patients will have disease reevaluation and then annual data collection for long-term toxicity, duration of response and survival.
Detailed description
This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression, molecular response, and immunologic parameters related to this treatment. Adult patients with indolent, advanced stage, anthracycline naive NHL requiring treatment may be eligible. Patients must have measurable disease, no severe organ dysfunction, and normal ejection fraction in older patients. Patients also must have adequate hematologic, hepatic and renal function, performance status, and life expectancy of at least 18 months. Patients may not have CNS lymphoma, uncontrolled co-morbid conditions, pregnancy, HIV, and active psychiatric conditions. Additionally, patients may not have had prior hypersensitivity to interferon-alpha, other cancer within 5 years, significant heart disease or myocardial infarction within the last 6 months, and history of thrombosis. Additionally, patients will have an ocular exam prior to treatment.
Patients in this study will receive 6 cycles of combination chemotherapy with the standard CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for six to eight cycles. Patients achieving at least a partial response to chemotherapy will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be continued for 12 months in the absence of signs of progressive/recurrent disease, or unacceptable toxicity/intolerance of therapy. PEG Intron dosing will be adjusted based on the presence of symptoms or other clinical manifestations of toxicity. Patients will undergo bone marrow evaluation for molecular testing at baseline. Those found to be positive will have repeat assessments performed post induction therapy, and after six months of PEG Intron. Patients will also undergo immunologic evaluation at baseline, post induction therapy, and after six months of PEG Intron. At the end of PEG Intron therapy, patients will have disease reevaluation and then annual data collection for long-term toxicity, duration of response and survival.
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: CHOP/Rituximab, Drug: PEG INTRONParticipants will receive 6 cycles of combination chemotherapy with the standard CHOP regimen given in conjunction with rituximab. Cycles are repeated at 21-day intervals for six to eight cycles. Participants achieving at least a partial response to chemotherapy will begin PEG Intron at a dose of 2g/kg/week subcutaneously. PEG Intron treatment will be continued for 12 months in the absence of signs of progressive/recurrent disease, or unacceptable toxicity/intolerance of therapy. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with a diagnosis of advanced stage indolent non-Hodgkin's lymphoma expressing the CD20 surface antigen (as measured by immunohistochemistry or flow cytometry on peripheral blood, marrow, or tumor tissue). Specific histologic subtypes which are eligible include follicular small cleaved cell (follicular grade 1) and follicular mixed small cleaved and large cell (follicular grade 2) lymphoma, and small lymphocytic lymphoma. Patients with indolent follicular lymphoma (follicular grades 1 and with areas of diffuse histology and patients with diffuse follicle center cell lymphoma are eligible as long as the diffuse areas are not felt to represent areas of transformation to diffuse large B-cell lymphoma.
- Patients with bulky stage II (at least one tumor mass >/= 5 cm), or stage III or stage IV disease.
- Patients with an expected life expectancy of at least 18 months.
- Karnofsky Performance Status >70 (ECOG 0, 1)
- No prior anthracycline/anthracenedione-based chemotherapy (e.g., CHOP, CNOP)
Key exclusion criteria (15 listed)
- Active CNS lymphoma.
- Uncontrolled/poorly controlled serious nonmalignant disease (e.g., uncontrolled diabetes mellitus, hypertension, angina, chronic obstructive pulmonary disease).
- History of hypersensitivity to interferon-alpha.
- Active uncontrolled infection.
- History of any other malignancy (except for treated squamous cell or basal cell carcinoma of the skin, or cervical intra-epithelial neoplasia of the cervix) within the past five years.
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 |
|---|---|---|
| CHOP/RituximabSix cycles of CHOP/Rituximab therapy at 21-day intervals. CHOP chemo will be administered on day 1 after rituximab. Cyclophosphamide750mg/m2 IV, Doxorubicin 50mg/m2 IV, Vincristine 1.4mg/m2 (max 2mg) IV, Prednisone 100mg PO daily x 5 days Rituximab 375mg/m2 | Drug | Arm 1 |
| PEG INTRONPegylated Interferon-alpha 2mg/kg/week for 52 weeks | Drug | Arm 1 |
Primary outcome
Time to Treatment Failure/Duration of Response/Time to Treatment Failure/Survival
Time frame: Treatment failure: registration to treatment discontinuation/withdrawal for progression, death, AE, etc. Progression: registration to progression. Duration of response: evaluation with a CR, CCR or PR to progression. Time to death: registration to death.
Treatment failure: registration to treatment discontinuation/withdrawal for progression, death, AE, etc. Progression: registration to progression. Duration of response: evaluation with a CR, CCR or PR to progression. Time to death: registration to death.
1 secondary outcome
Biologic/Immunologic Evaluation
Time frame: Baseline, post induction therapy and after six months of PEG-Intron.
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 14 Sep 2023.
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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.
Robert G Bociek, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHOP/Rituximab and PEG INTRON in people with Non-Hodgkins Lymphoma, run by University of Nebraska 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 16 inclusion and 15 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 14 Sep 2023. 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.
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?
Time to Treatment Failure/Duration of Response/Time to Treatment Failure/Survival (time frame: Treatment failure: registration to treatment discontinuation/withdrawal for progression, death, AE, etc. Progression: registration to progression. Duration of response: evaluation with a CR, CCR or PR to progression. Time to death: registration to death.). 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 14 Sep 2023.