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Trial record 2 of 23 for:    CD20 Fred Hutchinson

Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT00244855
Recruitment Status : Completed
First Posted : October 27, 2005
Results First Posted : May 22, 2017
Last Update Posted : May 22, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Maloney, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Marginal Zone Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Marginal Zone Lymphoma
Splenic Marginal Zone Lymphoma
Stage I Grade 1 Follicular Lymphoma
Stage I Grade 2 Follicular Lymphoma
Stage I Marginal Zone Lymphoma
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Marginal Zone Lymphoma
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia
Interventions Other: pharmacological study
Biological: rituximab
Drug: dexamethasone
Other: laboratory biomarker analysis
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Previous Treatment Previous Treatment
Hide Arm/Group Description

Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

pharmacological study: Correlative studies

rituximab: Given IV

dexamethasone: Given IV

laboratory biomarker analysis: Correlative studies

Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

pharmacological study: Correlative studies

rituximab: Given IV

dexamethasone: Given IV

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 7 25
Completed 7 24
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Previous Treatment No Previous Treatment Total
Hide Arm/Group Description

Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

pharmacological study: Correlative studies

rituximab: Given IV

dexamethasone: Given IV

laboratory biomarker analysis: Correlative studies

Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

pharmacological study: Correlative studies

rituximab: Given IV

dexamethasone: Given IV

laboratory biomarker analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 7 25 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 25 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  42.9%
14
  56.0%
17
  53.1%
>=65 years
4
  57.1%
11
  44.0%
15
  46.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 25 participants 32 participants
67
(42 to 79)
64
(38 to 85)
64
(38 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 25 participants 32 participants
Female
4
  57.1%
17
  68.0%
21
  65.6%
Male
3
  42.9%
8
  32.0%
11
  34.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 25 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.0%
1
   3.1%
Native Hawaiian or Other Pacific Islander
1
  14.3%
0
   0.0%
1
   3.1%
Black or African American
0
   0.0%
1
   4.0%
1
   3.1%
White
6
  85.7%
23
  92.0%
29
  90.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 25 participants 32 participants
7 25 32
1.Primary Outcome
Title Progression-free Survival
Hide Description Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method
Time Frame At 3 and 6 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Previous Treatment No Previous Treatment
Hide Arm/Group Description:

Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

pharmacological study: Correlative studies

rituximab: Given IV

dexamethasone: Given IV

laboratory biomarker analysis: Correlative studies

Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

pharmacological study: Correlative studies

rituximab: Given IV

dexamethasone: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 7 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Kaplan-Meier estimated % of patients
At 3 months after enrollment
92
(81 to 100)
71
(45 to 100)
At 6 months after enrollment
83
(70 to 100)
71
(45 to 100)
2.Secondary Outcome
Title Survival
Hide Description Percentage of patients remaining alive estimated according to the Kaplan-Meier method
Time Frame At 6 months, 12 months and 24 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Previous Treatment Previous Treatment
Hide Arm/Group Description:

Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

pharmacological study: Correlative studies

rituximab: Given IV

dexamethasone: Given IV

laboratory biomarker analysis: Correlative studies

Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

pharmacological study: Correlative studies

rituximab: Given IV

dexamethasone: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 7 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Kaplan-Meier estimated % of patients
At 6 months
96
(88 to 100)
100
(100 to 100)
At 12 months
96
(88 to 100)
100
(100 to 100)
At 24 months
91
(80 to 100)
67
(38 to 100)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Previous Treatment No Previous Treatment
Hide Arm/Group Description

Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

pharmacological study: Correlative studies

rituximab: Given IV

dexamethasone: Given IV

laboratory biomarker analysis: Correlative studies

Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

pharmacological study: Correlative studies

rituximab: Given IV

dexamethasone: Given IV

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Previous Treatment No Previous Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Previous Treatment No Previous Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Previous Treatment No Previous Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   5/7 (71.43%)   16/25 (64.00%) 
Blood and lymphatic system disorders     
Thrombocytopenia *  1/7 (14.29%)  1/25 (4.00%) 
Cardiac disorders     
Vasovagal episode *  1/7 (14.29%)  0/25 (0.00%) 
Hypotension *  1/7 (14.29%)  1/25 (4.00%) 
Endocrine disorders     
Hyperglycemia *  0/7 (0.00%)  1/25 (4.00%) 
Hypoglycemia *  0/7 (0.00%)  1/25 (4.00%) 
Gastrointestinal disorders     
Nausea *  1/7 (14.29%)  0/25 (0.00%) 
Anorexia *  0/7 (0.00%)  1/25 (4.00%) 
Vomiting *  1/7 (14.29%)  0/25 (0.00%) 
General disorders     
Fatigue *  0/7 (0.00%)  1/25 (4.00%) 
Pain *  1/7 (14.29%)  4/25 (16.00%) 
Fever *  1/7 (14.29%)  0/25 (0.00%) 
Sweating *  1/7 (14.29%)  0/25 (0.00%) 
Hepatobiliary disorders     
Hyperbilirubinemia *  0/7 (0.00%)  1/25 (4.00%) 
Immune system disorders     
Cytokine release syndrome *  1/7 (14.29%)  1/25 (4.00%) 
Lymphopenia *  2/7 (28.57%)  2/25 (8.00%) 
Urticaria *  1/7 (14.29%)  1/25 (4.00%) 
Allergic reaction *  0/7 (0.00%)  2/25 (8.00%) 
Infections and infestations     
Penile infection *  1/7 (14.29%)  0/25 (0.00%) 
Metabolism and nutrition disorders     
Hypercalcemia *  0/7 (0.00%)  1/25 (4.00%) 
Nervous system disorders     
Confusion *  0/7 (0.00%)  1/25 (4.00%) 
Neuropathy *  0/7 (0.00%)  1/25 (4.00%) 
Psychiatric disorders     
Anxiety *  0/7 (0.00%)  3/25 (12.00%) 
Renal and urinary disorders     
Urinary frequency *  0/7 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm *  1/7 (14.29%)  0/25 (0.00%) 
Cough *  1/7 (14.29%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritis *  0/7 (0.00%)  1/25 (4.00%) 
Rash *  0/7 (0.00%)  1/25 (4.00%) 
Vascular disorders     
Hypertension *  1/7 (14.29%)  0/25 (0.00%) 
Thrombosis *  1/7 (14.29%)  0/25 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Maloney
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-5616
EMail: dmaloney@fredhutch.org
Layout table for additonal information
Responsible Party: David Maloney, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00244855     History of Changes
Other Study ID Numbers: PSOC 2002
NCI-2011-00576 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: October 25, 2005
First Posted: October 27, 2005
Results First Submitted: April 14, 2017
Results First Posted: May 22, 2017
Last Update Posted: May 22, 2017