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Trial record 66 of 1148 for:    "Follicular lymphoma"

Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

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ClinicalTrials.gov Identifier: NCT00850499
Recruitment Status : Terminated
First Posted : February 25, 2009
Results First Posted : November 1, 2012
Last Update Posted : December 12, 2012
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Follicular Lymphoma
Interventions Drug: fludarabine
Drug: rituximab
Drug: VELCADE
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Velcade + Fludarabine Rituximab + Fludarabine
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 4 8
Completed 1 6
Not Completed 3 2
Reason Not Completed
Adverse Event             3             1
Lack of Efficacy             0             1
Arm/Group Title Velcade + Fludarabine Rituximab + Fludarabine Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 4 8 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  75.0%
6
  75.0%
9
  75.0%
>=65 years
1
  25.0%
2
  25.0%
3
  25.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 8 participants 12 participants
61.3  (12.84) 60.0  (10.06) 60.4  (10.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
Female
2
  50.0%
3
  37.5%
5
  41.7%
Male
2
  50.0%
5
  62.5%
7
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
France 0 3 3
Greece 0 1 1
Spain 1 0 1
Israel 1 0 1
Germany 0 1 1
Switzerland 1 0 1
Italy 1 3 4
1.Primary Outcome
Title Complete Response Rate
Hide Description The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.
Time Frame Up to 8 cycles (1 cycle is 35 days: 280 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Received at least one dose of study drug
Arm/Group Title Velcade + Fludarabine Rituximab + Fludarabine
Hide Arm/Group Description:
Velcade + Fludarabine
Rituximab + Fludarabine
Overall Number of Participants Analyzed 4 8
Measure Type: Number
Unit of Measure: participants
2 3
2.Secondary Outcome
Title Overall Response Rate
Hide Description The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.
Time Frame Up to 8 cycles (1 cycle is 35 days: 280 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Received at least one dose of study drug
Arm/Group Title Velcade + Fludarabine Rituximab + Fludarabine
Hide Arm/Group Description:
Velcade + Fludarabine
Rituximab + Fludarabine
Overall Number of Participants Analyzed 4 8
Measure Type: Number
Unit of Measure: participants
3 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Velcade + Fludarabine Rituximab + Fludarabine
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Velcade + Fludarabine Rituximab + Fludarabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Velcade + Fludarabine Rituximab + Fludarabine
Affected / at Risk (%) Affected / at Risk (%)
Total   2/4 (50.00%)   2/8 (25.00%) 
Blood and lymphatic system disorders     
Anaemia   1/4 (25.00%)  0/8 (0.00%) 
Febrile neutropenia   0/4 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders     
Abdominal pain   1/4 (25.00%)  0/8 (0.00%) 
Small Intestinal Obstruction   1/4 (25.00%)  0/8 (0.00%) 
General disorders     
General physical health deterioration   0/4 (0.00%)  1/8 (12.50%) 
Pyrexia   0/4 (0.00%)  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders     
Dypnoea   0/4 (0.00%)  1/8 (12.50%) 
Respiratory gas exchange disorder   0/4 (0.00%)  1/8 (12.50%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Velcade + Fludarabine Rituximab + Fludarabine
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   8/8 (100.00%) 
Blood and lymphatic system disorders     
Leukopenia   1/4 (25.00%)  2/8 (25.00%) 
Lymphopenia   0/4 (0.00%)  2/8 (25.00%) 
Neutropenia   1/4 (25.00%)  4/8 (50.00%) 
Thrombocytopenia   1/4 (25.00%)  3/8 (37.50%) 
Eye disorders     
Blepharitis   1/4 (25.00%)  0/8 (0.00%) 
Gastrointestinal disorders     
Constipation   2/4 (50.00%)  0/8 (0.00%) 
Diarrhoea   1/4 (25.00%)  0/8 (0.00%) 
Gastrointestinal pain   1/4 (25.00%)  0/8 (0.00%) 
Nausea   1/4 (25.00%)  1/8 (12.50%) 
General disorders     
Asthenia   1/4 (25.00%)  3/8 (37.50%) 
Fatigue   0/4 (0.00%)  2/8 (25.00%) 
Oedema peripheral   0/4 (0.00%)  1/8 (12.50%) 
Performance status decreased   0/4 (0.00%)  1/8 (12.50%) 
Infections and infestations     
Nasopharyngitis   0/4 (0.00%)  1/8 (12.50%) 
Pharyngitis   0/4 (0.00%)  1/8 (12.50%) 
Tinea infection   0/4 (0.00%)  1/8 (12.50%) 
Metabolism and nutrition disorders     
Decreased appetite   1/4 (25.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain   1/4 (25.00%)  0/8 (0.00%) 
Bone pain   1/4 (25.00%)  0/8 (0.00%) 
Osteoarthritis   0/4 (0.00%)  1/8 (12.50%) 
Nervous system disorders     
Peripheral sensory neuropathy   1/4 (25.00%)  0/8 (0.00%) 
Psychiatric disorders     
Conversion disorder   1/4 (25.00%)  0/8 (0.00%) 
Depression   1/4 (25.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease   0/4 (0.00%)  1/8 (12.50%) 
Cough   1/4 (25.00%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders     
Rash   0/4 (0.00%)  1/8 (12.50%) 
Skin reaction   0/4 (0.00%)  1/8 (12.50%) 
Indicates events were collected by systematic assessment
Early termination leading to small numbers of subjects analyzed
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: Andrew Cakana, MD, FRC Path
Organization: Johnson & Johnson Pharmaceutical Research & Development
EMail: [ACAKANA@ITS.JNJ.COM
Layout table for additonal information
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00850499     History of Changes
Other Study ID Numbers: 26866138-LYM-2033
First Submitted: February 24, 2009
First Posted: February 25, 2009
Results First Submitted: October 3, 2012
Results First Posted: November 1, 2012
Last Update Posted: December 12, 2012