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Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia

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ClinicalTrials.gov Identifier: NCT00060346
Recruitment Status : Terminated (slow accrual)
First Posted : May 7, 2003
Results First Posted : February 12, 2013
Last Update Posted : February 13, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Biological: rituximab
Drug: cyclophosphamide
Drug: Doxorubicin
Drug: Prednisone
Drug: Vincristine
Enrollment 16
Recruitment Details The study was activated on June 15, 2004, and closed due to slow accrual on April 26, 2007. Sixteen patients were accrued in this trial from Eastern Cooperative Oncology Group (ECOG) and Southwest Oncology Group (SWOG) institutions.
Pre-assignment Details  
Arm/Group Title Rituximab + CHOP
Hide Arm/Group Description

Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:

Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily

Period Title: Overall Study
Started 16
Eligible and Treated 16
Completed 16
Not Completed 0
Arm/Group Title Rituximab + CHOP
Hide Arm/Group Description

Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:

Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
59.5
(44.1 to 78.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
6
  37.5%
Male
10
  62.5%
1.Primary Outcome
Title Objective Response to Treatment
Hide Description Objective response assessed using standard myeloma response criteria. Objective response is defined as a > 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.
Time Frame Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible and treated patients are included in this analysis.
Arm/Group Title Rituximab + CHOP
Hide Arm/Group Description:

Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:

Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily

Overall Number of Participants Analyzed 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
0.938
(0.736 to 0.997)
Time Frame Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab + CHOP
Hide Arm/Group Description

Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:

Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily

All-Cause Mortality
Rituximab + CHOP
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab + CHOP
Affected / at Risk (%)
Total   16/16 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  1/16 (6.25%) 
Thrombosis/Embolism  1  1/16 (6.25%) 
Febrile neutropenia  1  2/16 (12.50%) 
Cardiac disorders   
Cardiac-Left Ventricular Function  1  1/16 (6.25%) 
Gastrointestinal disorders   
Nausea  1  1/16 (6.25%) 
Stomatitis  1  1/16 (6.25%) 
Abdominal Pain  1  1/16 (6.25%) 
General disorders   
Edema  1  1/16 (6.25%) 
Fatigue  1  1/16 (6.25%) 
Immune system disorders   
Allergic reaction  1  1/16 (6.25%) 
Infections and infestations   
Infection w/ Gr3-4 neutropenia  1  3/16 (18.75%) 
Infection w/o neutropenia  1  1/16 (6.25%) 
Investigations   
Leukopenia  1  8/16 (50.00%) 
Lymphopenia  1  8/16 (50.00%) 
Neutropenia  1  13/16 (81.25%) 
Nervous system disorders   
Neuropathy-motor  1  1/16 (6.25%) 
Neuropathy-sensory  1  2/16 (12.50%) 
Psychiatric disorders   
Insomnia  1  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/16 (12.50%) 
Vascular disorders   
Hypotension  1  2/16 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab + CHOP
Affected / at Risk (%)
Total   16/16 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  14/16 (87.50%) 
Cardiac disorders   
Palpitations  1  1/16 (6.25%) 
Sinus tachycardia  1  1/16 (6.25%) 
Cardiac-Left Ventricular Function  1  1/16 (6.25%) 
Ear and labyrinth disorders   
Earache  1  1/16 (6.25%) 
Gastrointestinal disorders   
Constipation  1  2/16 (12.50%) 
Dyspepsia  1  1/16 (6.25%) 
Dysphagia  1  2/16 (12.50%) 
Nausea  1  6/16 (37.50%) 
Stomatitis  1  4/16 (25.00%) 
Vomiting  1  4/16 (25.00%) 
Diarrhea w/o prior colostomy  1  2/16 (12.50%) 
Abdominal Pain  1  1/16 (6.25%) 
General disorders   
Edema  1  3/16 (18.75%) 
Fatigue  1  14/16 (87.50%) 
Fever  1  2/16 (12.50%) 
Rigors/chills  1  5/16 (31.25%) 
Constitutional symptoms  1  1/16 (6.25%) 
Pain-other  1  1/16 (6.25%) 
Infections and infestations   
Infection w/o neutropenia  1  1/16 (6.25%) 
Injury, poisoning and procedural complications   
Bruising  1  1/16 (6.25%) 
Investigations   
Leukopenia  1  16/16 (100.00%) 
Lymphopenia  1  15/16 (93.75%) 
Neutropenia  1  15/16 (93.75%) 
Thrombocytopenia  1  8/16 (50.00%) 
Weight gain  1  1/16 (6.25%) 
Alkaline phosphatase increased  1  2/16 (12.50%) 
Bilirubin increased  1  1/16 (6.25%) 
SGOT increased  1  5/16 (31.25%) 
Creatinine increased  1  4/16 (25.00%) 
Metabolism and nutrition disorders   
Anorexia  1  4/16 (25.00%) 
Hyperglycemia  1  9/16 (56.25%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/16 (6.25%) 
Myalgia  1  3/16 (18.75%) 
Nervous system disorders   
Taste disturbance  1  1/16 (6.25%) 
Dizziness/Lightheadedness  1  3/16 (18.75%) 
Neuropathy-motor  1  2/16 (12.50%) 
Neuropathy-sensory  1  11/16 (68.75%) 
Headache  1  3/16 (18.75%) 
Psychiatric disorders   
Insomnia  1  5/16 (31.25%) 
Anxiety/Agitation  1  2/16 (12.50%) 
Renal and urinary disorders   
Urinary Frequency/Urgency  1  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/16 (6.25%) 
Cough  1  6/16 (37.50%) 
Dyspnea  1  2/16 (12.50%) 
Skin and subcutaneous tissue disorders   
Sweating  1  2/16 (12.50%) 
Alopecia  1  9/16 (56.25%) 
Pruritus  1  1/16 (6.25%) 
Rash/desquamation  1  2/16 (12.50%) 
Skin- Other  1  1/16 (6.25%) 
Vascular disorders   
Hypotension  1  2/16 (12.50%) 
Flushing  1  2/16 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Publications of Results:
Abonour R, Zhang LA, Rajkumar V, et al.: Phase II pilot study of rituximab + CHOP in patients with newly diagnosed Waldenstroms macroglobulinemia, an Eastren Cooperative Oncology Group trial (study E1A02). [Abstract] Blood 110 (11): A-3616, 2007.
Layout table for additonal information
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00060346     History of Changes
Other Study ID Numbers: CDR0000301634
U10CA021115 ( U.S. NIH Grant/Contract )
E1A02 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
First Submitted: May 6, 2003
First Posted: May 7, 2003
Results First Submitted: January 10, 2013
Results First Posted: February 12, 2013
Last Update Posted: February 13, 2013