Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
Phase II Study of Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
1 other identifier
interventional
25
1 country
2
Brief Summary
The purpose of this study is to determine the percentage of people who can attain remission and the length of time such responses to therapy are sustained, as well as the side effects that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2003
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
June 2, 2014
CompletedJune 2, 2014
May 1, 2014
9 months
September 1, 2005
June 13, 2013
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Objective Response Rate
Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).
3 years
Time to Progression
Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.
49.1 months
Secondary Outcomes (1)
To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.
3 years
Study Arms (1)
Thalidomide and Rituximab
EXPERIMENTALThalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
Interventions
200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.
Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
Eligibility Criteria
You may qualify if:
- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia requiring therapy
- Baseline staging requirements
- Absolute Neutrophil Count \> 500/microliter (uL)
- Platelet Count \> 25,000/uL
- Serum creatinine \< 2.5mg/dL
- Total bilirubin and transaminase (SGOT) \< 2.5 X Upper Limit of Normal (ULN)
- Greater than 18 years of age
- Life expectancy of 3 months or greater
- Eastern Cooperative Oncology Group (ECOG) status performance of 0-2
You may not qualify if:
- Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry
- Pregnant or lactating women
- Serious co-morbid disease
- Uncontrolled bacterial, fungal or viral infection
- Active second malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steven P. Treon, MD, PhDlead
- Dana-Farber Cancer Institutecollaborator
- Massachusetts General Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Brigham and Women's Hospitalcollaborator
- Cape Cod Hospitalcollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
Treon SP, Soumerai JD, Branagan AR, Hunter ZR, Patterson CJ, Ioakimidis L, Briccetti FM, Pasmantier M, Zimbler H, Cooper RB, Moore M, Hill J 2nd, Rauch A, Garbo L, Chu L, Chua C, Nantel SH, Lovett DR, Boedeker H, Sonneborn H, Howard J, Musto P, Ciccarelli BT, Hatjiharissi E, Anderson KC. Thalidomide and rituximab in Waldenstrom macroglobulinemia. Blood. 2008 Dec 1;112(12):4452-7. doi: 10.1182/blood-2008-04-150854. Epub 2008 Aug 19.
PMID: 18713945RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steven P. Treon MD, PhD
- Organization
- Dana Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Steven P. Treon, MD, MA, PhD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Bing Center for WM
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
May 1, 2003
Primary Completion
February 1, 2004
Study Completion
February 1, 2008
Last Updated
June 2, 2014
Results First Posted
June 2, 2014
Record last verified: 2014-05