LymphomaPhase 2NCT00069966
Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse
A Phase 2 study testing filgrastim, rituximab and cisplatin in people with Lymphoma, run by Theradex at 29 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone, and cisplatin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- filgrastim, rituximab and cisplatin
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 29 sitesin 2 countries
- Study dates
- Apr 2003to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL)
- Any stage, with or without B symptoms
- The following subtypes are eligible:
- Diffuse large cell (B and T cell types)
- Anaplastic large cell
- Diffuse mixed cell
- Immunoblastic large cell
- Follicular large cell
- Transformed follicular NHL
- Diffuse aggressive not otherwise classified
- Burkitt-like lymphoma
- Bone marrow positive or negative
- At least 1 measurable lesion
- Patients with bone marrow as the only site of disease are eligible without a measurable lesion
- No more than 1 episode of progressive disease, occurring after a response (complete response [CR], complete response unconfirmed [CR_u], or partial response [PR]) to prior chemotherapy* NOTE: *Patients with less than a CR, CRu, or PR and no progression, but who are good candidates for high-dose chemotherapy with stem cell support may be eligible (will be decided on an individual basis)
- No chemotherapy-refractory disease, defined as follows:
- Stable or progressive disease documented at restaging immediately after the completion of induction therapy
- No lymphoblastic lymphoma, or mantle cell lymphoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-1
Life expectancy
- At least 3 months
Hematopoietic
- Neutrophil count at least 1,500/mm^3*
- Platelet count at least 100,000/mm^3* NOTE: *Lower values may be accepted if clearly due to bone marrow involvement by lymphoma
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
- AST or ALT no greater than 2.0 times ULN*
- Alkaline phosphatase no greater than 2.0 times ULN*
- No history or clinical symptoms of hepatitis B or hepatitis C virus
- Patients with seropositivity due to prior vaccination for hepatitis B are eligible NOTE: *Higher values may be accepted if clearly due to liver involvement by lymphoma
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- LVEF at least 50% by MUGA
- No clinically significant cardiovascular abnormalities
- No New York Heart Association grade II-IV cardiovascular disease
- No myocardial infarction within the past 6 months
- No severe cardiac arrhythmia
- No uncontrolled hypertension
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- HIV negative
- No clinically significant neurological abnormalities
- No condition that would preclude study safety or interfere with study results
- No concurrent serious uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior rituximab immediately after the first chemotherapy regimen allowed
Chemotherapy
- See Disease Characteristics
- See Biologic therapy
- At least 6 months since prior anthracycline therapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP])
- More than 2 years since prior fludarabine
- More than 2 years since prior nitrosoureas
- More than 1 year since prior platinum-based chemotherapy or cytarabine, unless a CR or CR_u was achieved
- No prior cumulative dose of cisplatin greater than 600 mg/m^2
- No prior single or cumulative dose of doxorubicin greater than 450 mg/m^2
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the whole pelvis
- No prior radioimmunotherapy
Surgery
- More than 4 weeks since prior major thoracic and/or abdominal surgery
- At least 1 week since prior minor surgery
Other
- Recovered from prior therapy
- Alopecia allowed
- Grade 1 peripheral neuropathy allowed
- More than 30 days since prior participation in another investigational drug study
- No other concurrent investigational drugs
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States28 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Gabrail Cancer Center - Canton Office
Canton, Ohio, 44718
Hematology-Oncology Associates of Illinois
Chicago, Illinois, 60611-2998
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, 44106-5055
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Rocky Mountain Cancer Centers - Colorado Springs
Colorado Springs, Colorado, 80933-1181
Baylor University Medical Center
Dallas, Texas, 75246
Rocky Mountain Cancer Centers - Denver Midtown
Denver, Colorado, 80218
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax
Fairfax, Virginia, 22031
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, 29615
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0084
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
North Shore University Hospital
Manhasset, New York, 11030
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226-3596
Pasco, Hernando Oncology Associates, P.A.
New Port Richey, Florida, 34652
Delaware Clinical & Laboratory Physicians
Newark, Delaware, 19713
Cancer Care Associates-West
Oklahoma City, Oklahoma, 73112-4414
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Arizona Oncology Associates - Craycroft Road Offices
Tucson, Arizona, 85712-2254
Piedmont Hematology-Oncology Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase II Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin (BSHAP) as Salvage in Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone, and cisplatin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed aggressive non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the antitumor activity of pixantrone, cytarabine, methylprednisolone, and cisplatin in patients with aggressive non-Hodgkin's lymphoma in first relapse.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the validity and safety of this regimen as a mobilization regimen before high-dose chemotherapy with stem cell support in these patients.
OUTLINE: This is an open-label, multicenter study.
- Salvage therapy: Patients receive pixantrone IV over 1 hour on day 1; cisplatin IV over 30 minutes on days 1-4; methylprednisolone IV over 15-30 minutes on days 1-5; and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After 2 courses of salvage therapy, patients are re-evaluated and treated as follows:
- Complete response (CR) or partial response (PR): Patients with a CR or PR who are suitable candidates for autologous stem cell transplantation (ASCT) proceed to mobilization therapy, high-dose chemotherapy, and ASCT. Patients with a CR or PR who are unsuitable candidates for ASCT continue to receive salvage therapy for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Stable disease: Patients with stable disease continue to receive salvage therapy for up to 6 courses. Patients who have a CR or PR after 3-4 courses of salvage therapy and who are suitable candidates for ASCT proceed to mobilization therapy, high-dose chemotherapy, and ASCT off study at the investigator's discretion.
- Mobilization therapy (optional regimen; regimen used for mobilization is at the investigator's discretion): Patients receive rituximab* IV on days 1 and 7; pixantrone IV over 1 hour on day 2; cisplatin IV over 30 minutes on days 2-5; cytarabine IV over 2 hours on day 6; and methylprednisolone IV over 15-30 minutes on days 2-6. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 7 and continuing until blood counts recover. Patients receive 1 or more courses of mobilization therapy during which stem cells are harvested. Patients then proceed to high-dose chemotherapy and subsequent re-infusion of harvested stem cells.
NOTE: *If this mobilization regimen is used, patients with T-cell lymphoma do not receive rituximab
- High-dose chemotherapy and ASCT: Patients receive high-dose chemotherapy and ASCT per institutional standard practice.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- filgrastim, rituximab, cisplatin, cytarabine, methylprednisolone
- Keywords
- recurrent adult diffuse large cell lymphoma, anaplastic large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult Burkitt lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Follicular, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
rituximabBiological
cisplatinDrug
cytarabineDrug
pixantrone dimaleateDrug
autologous bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Theradex
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Julie M. Vose, MD, Study chair, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069966
- Sponsor's protocol ID
- CDR0000316466
- Other IDs
- THERADEX-AZA-II-02, CWRU-NOVU-1403, SUNY-HSC-4849, NOVUSPHARMA-AZA-II-02
- Status last verified
- Nov 2004
- First submitted
- 3 Oct 2003
- Last updated
- 7 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin (BSHAP) as Salvage in Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00069966
- Acronym / sponsor ID
- CDR0000316466
- Conditions
- Lymphoma
- Keywords
- recurrent adult diffuse large cell lymphoma, anaplastic large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult Burkitt lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- TheradexIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- First posted
- 7 Oct 2003 (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 pixantrone, cytarabine, methylprednisolone, and cisplatin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed aggressive non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the antitumor activity of pixantrone, cytarabine, methylprednisolone, and cisplatin in patients with aggressive non-Hodgkin's lymphoma in first relapse.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the validity and safety of this regimen as a mobilization regimen before high-dose chemotherapy with stem cell support in these patients.
OUTLINE: This is an open-label, multicenter study.
- Salvage therapy: Patients receive pixantrone IV over 1 hour on day 1; cisplatin IV over 30 minutes on days 1-4; methylprednisolone IV over 15-30 minutes on days 1-5; and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After 2 courses of salvage therapy, patients are re-evaluated and treated as follows:
- Complete response (CR) or partial response (PR): Patients with a CR or PR who are suitable candidates for autologous stem cell transplantation (ASCT) proceed to mobilization therapy, high-dose chemotherapy, and ASCT. Patients with a CR or PR who are unsuitable candidates for ASCT continue to receive salvage therapy for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Stable disease: Patients with stable disease continue to receive salvage therapy for up to 6 courses. Patients who have a CR or PR after 3-4 courses of salvage therapy and who are suitable candidates for ASCT proceed to mobilization therapy, high-dose chemotherapy, and ASCT off study at the investigator's discretion.
- Mobilization therapy (optional regimen; regimen used for mobilization is at the investigator's discretion): Patients receive rituximab* IV on days 1 and 7; pixantrone IV over 1 hour on day 2; cisplatin IV over 30 minutes on days 2-5; cytarabine IV over 2 hours on day 6; and methylprednisolone IV over 15-30 minutes on days 2-6. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 7 and continuing until blood counts recover. Patients receive 1 or more courses of mobilization therapy during which stem cells are harvested. Patients then proceed to high-dose chemotherapy and subsequent re-infusion of harvested stem cells.
NOTE: *If this mobilization regimen is used, patients with T-cell lymphoma do not receive rituximab
- High-dose chemotherapy and ASCT: Patients receive high-dose chemotherapy and ASCT per institutional standard practice.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 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 |
|---|---|---|
| filgrastim | Biological | – |
| rituximab | Biological | – |
| cisplatin | Drug | – |
| cytarabine | Drug | – |
| methylprednisolone | Drug | – |
| pixantrone dimaleate | Drug | – |
| autologous bone marrow transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
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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.
Julie M. Vose, MD study chair
University of Nebraska
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, rituximab and cisplatin in people with Lymphoma, run by Theradex at 29 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Puerto Rico. 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?
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.
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 7 Jul 2009.