LymphomaPhase 2NCT00101010
Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Filgrastim, Pegfilgrastim and Rituximab in people with Lymphoma, run by M.D. Anderson Cancer Center at 7 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Filgrastim, Pegfilgrastim and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2005to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed diffuse large B-cell lymphoma
- Stage II, III, or IV disease
- Previously untreated disease
- Measurable or evaluable disease
- No primary central nervous system (CNS) lymphoma or follicular B-cell lymphoma
PATIENT CHARACTERISTICS:
Age
- 61 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3*
- Platelet count > 100,000/mm^3* NOTE: * Unless due to lymphoma-related hypersplenism or bone marrow infiltration
Hepatic
- Bilirubin < 2 mg/dL
- Hepatitis B surface antigen negative
- Hepatitis B core antibody negative
- Hepatitis C Virus antibody negative
Renal
- Creatinine < 2 mg/dL
Cardiovascular
- left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or ple gated acquisition (MUGA) scan
- No uncontrolled hypertension or cardiac symptoms
- Cardiologist consultation required for patients with stage A cardiac failure or any of the following known heart diseases:
- Diastolic dysfunction
- Prior coronary artery bypass graft
- Prior percutaneous transluminal coronary angioplasty
- Prior stent insertion
- Prior radiotherapy to the chest
- No myocardial infarction within the past 6 months
- No New York Heart Association class II-IV heart failure
- No uncontrolled angina
- No severe uncontrolled ventricular arrhythmias
- No clinically significant pericardial disease
- No acute ischemic or active conduction system abnormality by electrocardiogram (EKG)
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No psychiatric illness that would preclude study compliance or giving informed consent
- No other major life-threatening illness that would preclude study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Cardiovascular
Surgery
- See Cardiovascular
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Hematology Oncology Associates of Central New York, PC - Northeast Center
East Syracuse, New York, 13057-4510
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, 72913
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, 77030-4009
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Cancer Research for the Ozarks
Springfield, Missouri, 65804
About this study
Official title: A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab, cyclophosphamide, pegylated doxorubicin hydrochloride liposome (HCl), vincristine, and prednisone.
- Determine the cardiotoxicity and myelosuppression of this regimen in these patients.
Secondary
- Determine disease-free survival and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity, disease progression, active hepatitis B virus infection, or hepatitis. Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study.
Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.
- Conditions
- Lymphoma
- Being tested
- Filgrastim, Pegfilgrastim, Rituximab, Cyclophosphamide, Pegylated liposomal doxorubicin hydrochloride
- Keywords
- contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimBiological
Also called G-CSF, Neupogen
5 mcg/kg, SC daily, start 24 hours after chemotherapy
PegfilgrastimBiological
Also called Neulasta, PEG-G-CSF
6 mg SC one time (24 hours after chemotherapy)
RituximabBiological
Also called Rituxan
375 mg/m^2 intravenous piggy back (IVPB) on day 1, administered 1st
CyclophosphamideDrug
Also called Cytoxan, Neosar
750 mg/m^2 IVPB on day 1
Pegylated liposomal doxorubicin hydrochlorideDrug
Also called Caelyx, Doxil, liposomal doxorubicin, doxorubicin hydrochloride
40 mg/m^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1
PrednisoneDrug
40 mg/m^2 oral days 1 - 5.
2 mg IV, day 1
| Study group | Role | What they receive |
|---|---|---|
| Rituximab - Combination Chemotherapy | Experimental | Rituximab 375 mg/m^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses. Receives: Biological: Filgrastim; Biological: Pegfilgrastim; Biological: Rituximab; Drug: Cyclophosphamide; Drug: Pegylated liposomal doxorubicin hydrochloride; Drug: Prednisone; Drug: Vincristine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses
Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on International Workshop Criteria (IWG) for Tumor Response Criteria assessed with CT \& FDG-PET scans at 4 cycles (12 weeks). CR defined as disappearance of all target and non-target lesions in liver \& spleen, \& all lymph node masses regressed to normal size. PR defined as ≥50% reduction in sum of product of diameters (SPD) for measured lymph nodes, splenic \& liver lesions separately compared to baseline SPD. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow.
Measured: Evaluation after 12 weeks (4 cycles of 21 days)
Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses
Ejection fraction ( EF) refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction. Cardiology evaluation performed before second dose of pegylated liposomal doxorubicin or before entry onto trial, re-evaluation by cardiologist obtained in asymptomatic patients after chemotherapy cycle 4 and again after completion of therapy, and more often if symptomatic. Severe cardiac toxicity considered to be both Grade 3 and 4, and are graded according to NCI common toxicity criteria, CTCAE version 3.0.
Measured: Up to 24 weeks (8 cycles of 21 days)
Secondary outcomes (2)
Survival Rate
The percentage of participants still alive after treatment. Survival information obtained 1 month after completion of treatment, then every 3 months for 1 year, every 4 months for one year and every 6 months thereafter.
Measured: Up to 5 years
Disease-free Survival
The percentage of participants with no disease progression for period of time after treatment. Survival assessed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 3 years, and then yearly thereafter up to 5 years.
Measured: Up to 5 years or until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Ortho Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Maria A. Rodriguez, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101010
- Sponsor's protocol ID
- CDR0000407533
- Other IDs
- MDA-CCOP-2004-0305, NCI-6485, 2004-0305, NCI-2009-00064, 2U10CA045809
- Status last verified
- Sep 2020
- First submitted
- 7 Jan 2005
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00101010
- Acronym / sponsor ID
- CDR0000407533
- Conditions
- Lymphoma
- Keywords
- contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Ortho Biotech, Inc.
- Study start
- Sep 2005
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Jan 2005 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab, cyclophosphamide, pegylated doxorubicin hydrochloride liposome (HCl), vincristine, and prednisone.
- Determine the cardiotoxicity and myelosuppression of this regimen in these patients.
Secondary
- Determine disease-free survival and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity, disease progression, active hepatitis B virus infection, or hepatitis. Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study.
Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab - Combination Chemotherapy | Experimental | Biological: Filgrastim, Biological: Pegfilgrastim, Biological: Rituximab, Drug: Cyclophosphamide, Drug: Pegylated liposomal doxorubicin hydrochloride, Drug: Prednisone, Drug: Vincristine SulfateRituximab 375 mg/m^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses. |
Who may qualify
- Ages
- 61 years and older
- 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 |
|---|---|---|
| FilgrastimAlso: G-CSF, Neupogen5 mcg/kg, SC daily, start 24 hours after chemotherapy | Biological | Rituximab - Combination Chemotherapy |
| PegfilgrastimAlso: Neulasta, PEG-G-CSF6 mg SC one time (24 hours after chemotherapy) | Biological | Rituximab - Combination Chemotherapy |
| RituximabAlso: Rituxan375 mg/m^2 intravenous piggy back (IVPB) on day 1, administered 1st | Biological | Rituximab - Combination Chemotherapy |
| CyclophosphamideAlso: Cytoxan, Neosar750 mg/m^2 IVPB on day 1 | Drug | Rituximab - Combination Chemotherapy |
| Pegylated liposomal doxorubicin hydrochlorideAlso: Caelyx, Doxil, liposomal doxorubicin, doxorubicin hydrochloride40 mg/m^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1 | Drug | Rituximab - Combination Chemotherapy |
| Prednisone40 mg/m^2 oral days 1 - 5. | Drug | Rituximab - Combination Chemotherapy |
| Vincristine Sulfate2 mg IV, day 1 | Drug | Rituximab - Combination Chemotherapy |
Primary outcome
Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses
Time frame: Evaluation after 12 weeks (4 cycles of 21 days)
Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on International Workshop Criteria (IWG) for Tumor Response Criteria assessed with CT \& FDG-PET scans at 4 cycles (12 weeks). CR defined as disappearance of all target and non-target lesions in liver \& spleen, \& all lymph node masses regressed to normal size. PR defined as ≥50% reduction in sum of product of diameters (SPD) for measured lymph nodes, splenic \& liver lesions separately compared to baseline SPD. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow.
Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses
Time frame: Up to 24 weeks (8 cycles of 21 days)
Ejection fraction ( EF) refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction. Cardiology evaluation performed before second dose of pegylated liposomal doxorubicin or before entry onto trial, re-evaluation by cardiologist obtained in asymptomatic patients after chemotherapy cycle 4 and again after completion of therapy, and more often if symptomatic. Severe cardiac toxicity considered to be both Grade 3 and 4, and are graded according to NCI common toxicity criteria, CTCAE version 3.0.
2 secondary outcomes
Survival Rate
Time frame: Up to 5 years
Disease-free Survival
Time frame: Up to 5 years or until disease progression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maria A. Rodriguez, MD study chair
M.D. Anderson Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgrastim, Pegfilgrastim and Rituximab in people with Lymphoma, run by M.D. Anderson Cancer Center at 7 sites 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?
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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses (time frame: Evaluation after 12 weeks (4 cycles of 21 days)). 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?
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 19 Oct 2020.