LymphomaPhase 2NCT00020800
Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
A Phase 2 study testing rituximab and fludarabine phosphate in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 18 sites in 4 countries.
Trial summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab and fludarabine phosphate
- How many people
- 7 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Sep 2001to Apr 2003
- 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:
- Diagnosis of Waldenstrom's macroglobulinemia
- CD20 positive by bone marrow immunohistochemistry or flow cytometry
- Presence of monoclonal paraprotein
- IgM level at least 2 times upper limit of normal (ULN)
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- At least 6 months
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 25,000/mm^3
Hepatic:
- Bilirubin less than 2.5 times ULN
- SGOT less than 2.5 times ULN
Renal:
- Creatinine less than 2.5 mg/dL
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after study
- No serious comorbid disease
- No uncontrolled bacterial, fungal, or viral infection
- No other active malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior rituximab
- No prior nucleoside analogue therapy
Chemotherapy:
- At least 30 days since prior chemotherapy
Endocrine therapy:
- At least 30 days since prior steroid therapy
- No concurrent corticosteroids
Radiotherapy:
- At least 30 days since prior radiotherapy
Surgery:
- Not specified
Other:
- No more than 2 prior courses of therapy
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
United States14 sites
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Tuft-New England Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
Barrett Cancer Center
Cincinnati, Ohio, 45267-0502
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Arizona Cancer Center
Tucson, Arizona, 85724
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
Canada2 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Chedoke-McMaster Hospitals
Hamilton, Ontario, L8N 3Z5
United Kingdom1 site
Saint Bartholomew's Hospital
London, England, EC1A 7BE
About this study
Official title: Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstrom's macroglobulinemia.
Read the detailed description
OBJECTIVES:
- Determine the objective response and time to treatment failure in patients with Waldenstrom's macroglobulinemia treated with rituximab and fludarabine.
- Determine the toxicity of this regimen in these patients.
- Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27.
Patients are followed at least every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- rituximab, fludarabine phosphate
- Keywords
- Waldenström macroglobulinemia
- Medical subject headings
- Lymphoma, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2001
- Primary completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive 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
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Christos E. Emmanouilides, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020800
- Sponsor's protocol ID
- CDR0000068714
- Other IDs
- UCLA-0101063, NCI-G01-1960
- Status last verified
- Jan 2013
- First submitted
- 11 Jul 2001
- Last updated
- 8 Jan 2013
- Results posted
- No
Publications
Treon SP, Branagan AR, Ioakimidis L, Soumerai JD, Patterson CJ, Turnbull B, Wasi P, Emmanouilides C, Frankel SR, Lister A, Morel P, Matous J, Gregory SA, Kimby E. Long-term outcomes to fludarabine and rituximab in Waldenstrom macroglobulinemia. Blood. 2009 Apr 16;113(16):3673-8. doi: 10.1182/blood-2008-09-177329. Epub 2008 Nov 17.
PubMed 19015393
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
- ClinicalTrials.gov ID
- NCT00020800
- Acronym / sponsor ID
- CDR0000068714
- Conditions
- Lymphoma
- Keywords
- Waldenström macroglobulinemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2001
- Primary completion
- Apr 2003 (actual)
- First posted
- 27 Jan 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: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstrom's macroglobulinemia.
Detailed description
OBJECTIVES:
- Determine the objective response and time to treatment failure in patients with Waldenstrom's macroglobulinemia treated with rituximab and fludarabine.
- Determine the toxicity of this regimen in these patients.
- Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27.
Patients are followed at least every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| rituximab | Biological | – |
| fludarabine phosphate | Drug | – |
Primary outcome
Not reported in the source record.
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 8 Jan 2013.
- Results publication: PubMed 19015393Treon SP, Branagan AR, Ioakimidis L, Soumerai JD, Patterson CJ, Turnbull B, Wasi P, Emmanouilides C, Frankel SR, Lister A, Morel P, Matous J, Gregory SA, Kimby E. Long-term outcomes to fludarabine and rituximab in Waldenstrom macroglobulinemia. Blood. 2009 Apr 16;113(16):3673-8. doi: 10.1182/blood-2008-09-177329. Epub 2008 Nov 17.
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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.
Christos E. Emmanouilides, MD principal investigator
Jonsson Comprehensive Cancer Center
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab and fludarabine phosphate in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 18 sites in 4 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: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, Sweden, United Kingdom. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00020800, which also lists 1 linked publication.
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 8 Jan 2013.