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Trial record 97 of 115 for:    cancer | butyrate

Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia

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ClinicalTrials.gov Identifier: NCT00133991
Recruitment Status : Completed
First Posted : August 24, 2005
Results First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Interventions Biological: Filgrastim
Biological: Rituximab
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Methotrexate
Drug: Prednisone
Drug: Hydrocortisone
Drug: Vincristine
Drug: Leucovorin
Enrollment 23
Recruitment Details  
Pre-assignment Details 2 participants were found to be HIV+ after initiating the study and are considered to be screen failures as defined by the protocol.
Arm/Group Title R-CVP + HiCy
Hide Arm/Group Description Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
Period Title: Overall Study
Started 21
Completed 17
Not Completed 4
Reason Not Completed
Death             4
Arm/Group Title R-CVP + HiCy
Hide Arm/Group Description Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  81.0%
>=65 years
4
  19.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
53
(34 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
7
  33.3%
Male
14
  66.7%
1.Primary Outcome
Title Overall Response Rate
Hide Description Number of participants who have a complete or partial remission (2007 International Working Group criteria).
Time Frame Up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The 4 participants who died during treatment were not analyzed for this outcome.
Arm/Group Title R-CVP + HiCy
Hide Arm/Group Description:
Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
Complete remission
11
  64.7%
Partial remission
2
  11.8%
2.Primary Outcome
Title Overall Survival
Hide Description Percentage of participants alive at 1 year and at 3 years.
Time Frame 1 year and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title R-CVP + HiCy
Hide Arm/Group Description:
Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1 year
57
(40 to 83)
3 years
57
(40 to 83)
3.Primary Outcome
Title Event-free Survival
Hide Description Percentage of participants alive without relapse at 1 year and 3 years.
Time Frame 1 year and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title R-CVP + HiCy
Hide Arm/Group Description:
Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1 year
52
(35 to 79)
3 years
52
(35 to 79)
4.Primary Outcome
Title Percentage of Participants Experiencing Grade 3-5 Toxicity
Hide Description Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria).
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title R-CVP + HiCy
Hide Arm/Group Description:
Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
21
 100.0%
5.Secondary Outcome
Title Relapse Pattern
Hide Description Percentage of participants experiencing central nervous system (CNS) and systemic relapse.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The 4 participants who died during treatment were not analyzed for this outcome.
Arm/Group Title R-CVP + HiCy
Hide Arm/Group Description:
Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
Systemic relapse only
3
  17.6%
Systemic and CNS relapse
2
  11.8%
Time Frame Up to 2 years
Adverse Event Reporting Description Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
 
Arm/Group Title R-CVP + HiCy
Hide Arm/Group Description Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
All-Cause Mortality
R-CVP + HiCy
Affected / at Risk (%)
Total   9/21 (42.86%)    
Show Serious Adverse Events Hide Serious Adverse Events
R-CVP + HiCy
Affected / at Risk (%) # Events
Total   12/21 (57.14%)    
Cardiac disorders   
Atrial fibrillation  1  1/21 (4.76%)  1
Hypotension  1  1/21 (4.76%)  2
Pericarditis  1  1/21 (4.76%)  1
Gastrointestinal disorders   
Colitis  1  1/21 (4.76%)  1
General disorders   
Somnolence  1  1/21 (4.76%)  1
Hepatobiliary disorders   
Ascites  1  1/21 (4.76%)  1
Infections and infestations   
Blood infection  1  1/21 (4.76%)  1
Encephalitis  1  1/21 (4.76%)  1
Febrile neutropenia  1  2/21 (9.52%)  2
Pneumonia  1  1/21 (4.76%)  1
Sepsis  1  1/21 (4.76%)  1
Metabolism and nutrition disorders   
Tumor lysis syndrome  1  1/21 (4.76%)  1
Musculoskeletal and connective tissue disorders   
Pain - chest  1  1/21 (4.76%)  1
Wound complication  1  1/21 (4.76%)  1
Nervous system disorders   
Stroke  1  1/21 (4.76%)  1
Subdural hematoma  1  1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/21 (4.76%)  1
Dyspnea  1  1/21 (4.76%)  1
Hypoxia  1  1/21 (4.76%)  1
1
Term from vocabulary, CTCAE (3.0)
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%
R-CVP + HiCy
Affected / at Risk (%) # Events
Total   21/21 (100.00%)    
Cardiac disorders   
Atrial fibrillation  1  2/21 (9.52%)  2
Bradycardia  1  2/21 (9.52%)  4
Deep vein thrombosis  1  3/21 (14.29%)  3
Edema  1  5/21 (23.81%)  10
Hypertension  1  2/21 (9.52%)  2
Hypotension  1  7/21 (33.33%)  23
Lightheadedness  1  4/21 (19.05%)  5
Tachycardia  1  2/21 (9.52%)  3
Gastrointestinal disorders   
Constipation  1  9/21 (42.86%)  19
Anorexia  1  3/21 (14.29%)  3
Diarrhea  1  6/21 (28.57%)  12
Dysphagia  1  2/21 (9.52%)  3
Mucositis  1  2/21 (9.52%)  7
Nausea  1  6/21 (28.57%)  18
Vomiting  1  7/21 (33.33%)  20
Xerostomia  1  2/21 (9.52%)  3
General disorders   
Anasarca  1  2/21 (9.52%)  2
Chills  1  3/21 (14.29%)  5
Cough  1  3/21 (14.29%)  5
Fatigue  1  7/21 (33.33%)  13
Headache  1  11/21 (52.38%)  27
Immune system disorders   
Allergic reaction  1  3/21 (14.29%)  3
Transfusion reaction  1  3/21 (14.29%)  4
Infections and infestations   
Febrile neutropenia  1  6/21 (28.57%)  8
Fever  1  6/21 (28.57%)  14
Infection  1  5/21 (23.81%)  8
Pneumonia  1  2/21 (9.52%)  2
Thrush  1  4/21 (19.05%)  5
Investigations   
Anemia  1  3/21 (14.29%)  6
High alkaline phosphatase  1  2/21 (9.52%)  7
High ALT  1  3/21 (14.29%)  9
High AST  1  5/21 (23.81%)  14
Hyperbilirubinemia  1  5/21 (23.81%)  14
Hyperglycemia  1  3/21 (14.29%)  11
Hypoalbuminemia  1  2/21 (9.52%)  5
Hypocalcemia  1  3/21 (14.29%)  7
Hypokalemia  1  3/21 (14.29%)  7
Hypophosphatemia  1  2/21 (9.52%)  3
Leukopenia  1  8/21 (38.10%)  42
Lymphopenia  1  4/21 (19.05%)  26
Neutropenia  1  5/21 (23.81%)  17
Thrombocytopenia  1  6/21 (28.57%)  36
Musculoskeletal and connective tissue disorders   
Incontinence  1  3/21 (14.29%)  7
Pain - general  1  3/21 (14.29%)  4
Pain - abdomen  1  7/21 (33.33%)  12
Pain - back  1  9/21 (42.86%)  15
Pain - chest  1  4/21 (19.05%)  4
Pain - foot  1  2/21 (9.52%)  2
Pain - hip  1  2/21 (9.52%)  2
Pain - leg  1  5/21 (23.81%)  5
Pain - neck  1  3/21 (14.29%)  3
Nervous system disorders   
Blurred vision  1  2/21 (9.52%)  2
Confusion  1  3/21 (14.29%)  3
Dizziness  1  4/21 (19.05%)  7
Drowsiness  1  2/21 (9.52%)  4
Facial droop  1  2/21 (9.52%)  2
Hallucination  1  2/21 (9.52%)  3
Insomnia  1  2/21 (9.52%)  2
Neuropathy  1  9/21 (42.86%)  19
Somnolence  1  2/21 (9.52%)  3
Weakness  1  3/21 (14.29%)  11
Renal and urinary disorders   
Hematuria  1  2/21 (9.52%)  2
Renal failure  1  2/21 (9.52%)  2
Urinary frequency  1  2/21 (9.52%)  2
Urinary retention  1  2/21 (9.52%)  2
Reproductive system and breast disorders   
Vaginal bleeding  1  2/21 (9.52%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  10/21 (47.62%)  18
Hypoxia  1  6/21 (28.57%)  12
Pleural effusion  1  2/21 (9.52%)  2
Wheezing  1  3/21 (14.29%)  7
Skin and subcutaneous tissue disorders   
Rash  1  3/21 (14.29%)  3
Sweating  1  4/21 (19.05%)  4
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by 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: Yvette Kasamon, MD
Organization: Johns Hopkins University
EMail: ykasamon@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00133991     History of Changes
Other Study ID Numbers: J0409
P50CA096888 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
NA_00035765 ( Other Identifier: JHMIRB )
First Submitted: August 22, 2005
First Posted: August 24, 2005
Results First Submitted: August 17, 2018
Results First Posted: September 17, 2018
Last Update Posted: September 17, 2018