LymphomaPhase 2NCT00726700
Pegfilgrastim and Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Aggressive B-Cell Non-Hodgkin Lymphoma
A Phase 2 study testing pegfilgrastim, rituximab and cyclophosphamide in people with Lymphoma, run by Universität des Saarlandes.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 61 to 80 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- pegfilgrastim, rituximab and cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Feb 2012
- 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 61 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of CD20-positive B-cell non-Hodgkin lymphoma (NHL)
- Confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement (if there is no lymph node involvement)
- Results of the immunohistological analysis of expression of the CD20 antigen by lymphoma cells must be obtained
- Aggressive disease, including any of the following B-cell NHL
- Stage III follicular lymphoma
- Stage III follicular lymphoma and diffuse B-cell lymphoma
- Lymphoblastic precursor B-cell lymphoma
- Diffuse large B-cell lymphoma, including any of the following subtypes:
- Centroblastic
- Immunoblastic
- Plasmablastic
- Anaplastic large cell
- T-cell rich B-cell lymphoma
- Primary effusion lymphoma
- Intravasal B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Mantle zone lymphoma
- Burkitt or Burkitt-like lymphoma
- Aggressive marginal zone lymphoma (monocytoid)
- All risk group allowed
- Age adjusted IPI 0-3
- Previously untreated disease
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- No other serious concurrent diseases
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Randomized Phase II Study About the Application of Pegfilgrastim (Neulasta) at Day 2 or Day 4 Within the Treatment in Patients With Aggressive Non-Hodgkin's Lymphoma Aged 61 to 80 Years With 6 or 8 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 14-day Intervals (CHOP-14), Both With or Without the Monoclonal Anti-CD20 Antibody Rituximab
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether combination chemotherapy and pegfilgrastim is more effective when given with or without rituximab in treating non-Hodgkin lymphoma.
PURPOSE: This phase II trial is studying the side effects of giving pegfilgrastim and combination chemotherapy together with or without rituximab and to see how well it works in treating older patients with aggressive B-cell non-Hodgkin lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the side effects of pegfilgrastim and cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) with or without rituximab in older patients with aggressive B-cell non-Hodgkin lymphoma.
- Determine adherence to therapy regimens in these patients.
- Determine antitumor effectivity of immunochemotherapy.
OUTLINE: This is a multicenter study.
All patients receive prephase treatment comprising vincristine on day -6 and prednisone on days -6 to 0. Patients are then randomized to 1 of 2 treatment arms.
- Arm I (without rituximab): Patients receive pegfilgrastim subcutaneously (SC) on day 2 or 4 and CHOP comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (with rituximab): Patients receive pegfilgrastim and CHOP for up to 6-8 courses as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP) on day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses.
Patients with bulky disease or extranodal disease also undergo radiotherapy.
- Conditions
- Lymphoma
- Being tested
- pegfilgrastim, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone
- Keywords
- stage III grade 3 follicular lymphoma, stage I adult lymphoblastic lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, anaplastic large cell lymphoma, stage III adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, stage III mantle cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Burkitt Lymphoma, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegfilgrastimBiological
Given subcutaneously
rituximabBiological
Given IV
cyclophosphamideDrug
Given IV
Given IV
prednisoneDrug
Given orally
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (without rituximab) | Active comparator | Patients receive pegfilgrastim subcutaneously (SC) on day 2 or 4 and CHOP comprising cyclophosphamide IV, doxorubicin IV, vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity. Receives: Biological: pegfilgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate |
| Arm II (with rituximab) | Experimental | Patients receive pegfilgrastim and CHOP for up to 6-8 courses as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP) on day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses. Receives: Biological: pegfilgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia
median of two measurements of hemoglobin, leukocyte and platelet counts per chemotherapy cycle per Patient in correlation with median pegfilgrastim serum levels at day 1 of the next chemotherapy cycle
Measured: through chemotherapy administration (up to 112 days respectively)
comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia
rates and grades of leukocytopenias and infections according to NCI-CTC criteria (version 2)
Measured: through chemotherapy administration (up to 112 days respectively)
Secondary outcomes (3)
Adherence to therapy regimens
the median overall treatment duration
Measured: through chemotherapy administration (up to 112 days respectively)
Antitumor effectivity
progression-free survival
Measured: median time of observation up to 3 years
Disease-free survival
period of disease-free survival
Measured: median time of observation up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startMay 2004
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Hartmann, MD, Study chair, Universitaetsklinikum des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726700
- Sponsor's protocol ID
- DSHNHL-2003-2
- Other IDs
- CDR0000454473, EU-20534
- Status last verified
- Jul 2021
- First submitted
- 31 Jul 2008
- Last updated
- 7 Jul 2021
- Results posted
- No
Publications
Zwick C, Hartmann F, Zeynalova S, Poschel V, Nickenig C, Reiser M, Lengfelder E, Peter N, Schlimok G, Schubert J, Schmitz N, Loeffler M, Pfreundschuh M; German High-Grade Non-Hodgkin Lymphoma Study Group. Randomized comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia. Ann Oncol. 2011 Aug;22(8):1872-7. doi: 10.1093/annonc/mdq674. Epub 2011 Feb 3.
PubMed 21292644Muller C, Murawski N, Wiesen MH, Held G, Poeschel V, Zeynalova S, Wenger M, Nickenig C, Peter N, Lengfelder E, Metzner B, Rixecker T, Zwick C, Pfreundschuh M, Reiser M. The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL. Blood. 2012 Apr 5;119(14):3276-84. doi: 10.1182/blood-2011-09-380949. Epub 2012 Feb 15.
PubMed 22337718
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study About the Application of Pegfilgrastim (Neulasta) at Day 2 or Day 4 Within the Treatment in Patients With Aggressive Non-Hodgkin's Lymphoma Aged 61 to 80 Years With 6 or 8 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 14-day Intervals (CHOP-14), Both With or Without the Monoclonal Anti-CD20 Antibody Rituximab
- ClinicalTrials.gov ID
- NCT00726700
- Acronym / sponsor ID
- DSHNHL-2003-2
- Conditions
- Lymphoma
- Keywords
- stage III grade 3 follicular lymphoma, stage I adult lymphoblastic lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, anaplastic large cell lymphoma, stage III adult diffuse large cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Aug 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.
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether combination chemotherapy and pegfilgrastim is more effective when given with or without rituximab in treating non-Hodgkin lymphoma.
PURPOSE: This phase II trial is studying the side effects of giving pegfilgrastim and combination chemotherapy together with or without rituximab and to see how well it works in treating older patients with aggressive B-cell non-Hodgkin lymphoma.
Detailed description
OBJECTIVES:
- Determine the side effects of pegfilgrastim and cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) with or without rituximab in older patients with aggressive B-cell non-Hodgkin lymphoma.
- Determine adherence to therapy regimens in these patients.
- Determine antitumor effectivity of immunochemotherapy.
OUTLINE: This is a multicenter study.
All patients receive prephase treatment comprising vincristine on day -6 and prednisone on days -6 to 0. Patients are then randomized to 1 of 2 treatment arms.
- Arm I (without rituximab): Patients receive pegfilgrastim subcutaneously (SC) on day 2 or 4 and CHOP comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (with rituximab): Patients receive pegfilgrastim and CHOP for up to 6-8 courses as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP) on day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses.
Patients with bulky disease or extranodal disease also undergo radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (without rituximab) | Active comparator | Biological: pegfilgrastim, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: prednisone, Drug: vincristine sulfatePatients receive pegfilgrastim subcutaneously (SC) on day 2 or 4 and CHOP comprising cyclophosphamide IV, doxorubicin IV, vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2 weeks for up to 6-8 courses in the absence of disease progression or unacceptable toxicity. |
| Arm II (with rituximab) | Experimental | Biological: pegfilgrastim, Biological: rituximab, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: prednisone, Drug: vincristine sulfatePatients receive pegfilgrastim and CHOP for up to 6-8 courses as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP) on day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses. |
Who may qualify
- Ages
- 61 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| pegfilgrastimGiven subcutaneously | Biological | Arm I (without rituximab), Arm II (with rituximab) |
| rituximabGiven IV | Biological | Arm II (with rituximab) |
| cyclophosphamideGiven IV | Drug | Arm I (without rituximab), Arm II (with rituximab) |
| doxorubicin hydrochlorideGiven IV | Drug | Arm I (without rituximab), Arm II (with rituximab) |
| prednisoneGiven orally | Drug | Arm I (without rituximab), Arm II (with rituximab) |
| vincristine sulfateGiven IV | Drug | Arm I (without rituximab), Arm II (with rituximab) |
Primary outcome
comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia
Time frame: through chemotherapy administration (up to 112 days respectively)
median of two measurements of hemoglobin, leukocyte and platelet counts per chemotherapy cycle per Patient in correlation with median pegfilgrastim serum levels at day 1 of the next chemotherapy cycle
comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia
Time frame: through chemotherapy administration (up to 112 days respectively)
rates and grades of leukocytopenias and infections according to NCI-CTC criteria (version 2)
3 secondary outcomes
Adherence to therapy regimens
Time frame: through chemotherapy administration (up to 112 days respectively)
Antitumor effectivity
Time frame: median time of observation up to 3 years
Disease-free survival
Time frame: median time of observation up to 3 years
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 7 Jul 2021.
- Background: PubMed 21292644Zwick C, Hartmann F, Zeynalova S, Poschel V, Nickenig C, Reiser M, Lengfelder E, Peter N, Schlimok G, Schubert J, Schmitz N, Loeffler M, Pfreundschuh M; German High-Grade Non-Hodgkin Lymphoma Study Group. Randomized comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia. Ann Oncol. 2011 Aug;22(8):1872-7. doi: 10.1093/annonc/mdq674. Epub 2011 Feb 3.
- Derived from this study: PubMed 22337718Muller C, Murawski N, Wiesen MH, Held G, Poeschel V, Zeynalova S, Wenger M, Nickenig C, Peter N, Lengfelder E, Metzner B, Rixecker T, Zwick C, Pfreundschuh M, Reiser M. The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL. Blood. 2012 Apr 5;119(14):3276-84. doi: 10.1182/blood-2011-09-380949. Epub 2012 Feb 15.
- Related InfoLink provided by the sponsor.
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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.
Frank Hartmann, MD study chair
Universitaetsklinikum des Saarlandes
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pegfilgrastim, rituximab and cyclophosphamide in people with Lymphoma, run by Universität des Saarlandes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Jul 2021. 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?
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?
comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia (time frame: through chemotherapy administration (up to 112 days respectively)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00726700, which also lists 2 linked publications.
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 7 Jul 2021.