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Trial record 80 of 138 for:    "T-Cell Adult Acute Lymphocytic Leukemia" | "Immunologic Factors"

Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms

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ClinicalTrials.gov Identifier: NCT00217425
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 7, 2014
Last Update Posted : May 7, 2014
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: bevacizumab
Drug: cyclophosphamide
Drug: doxorubicin
Drug: prednisone
Drug: vincristine
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (A-CHOP Followed by MA)
Hide Arm/Group Description Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
Period Title: Overall Study
Started 46
Treated 44
Eligible and Treated 39
Completed 9
Not Completed 37
Reason Not Completed
Never started treatment             2
Patient ineligible             5
Lack of Efficacy             13
Adverse Event             8
Withdrawal by Subject             4
Other complicating disease             1
Other             4
Arm/Group Title Treatment (A-CHOP Followed by MA)
Hide Arm/Group Description Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
Eligible and treated
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants
60
(21 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
11
  28.2%
Male
28
  71.8%
1.Primary Outcome
Title 12-Month Progression-Free Survival (PFS)
Hide Description 12-month progression-free survival is defined as the probability of patients remaining alive and progression-free at 12 months from study entry.
Time Frame Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Treatment (A-CHOP Followed by MA)
Hide Arm/Group Description:
Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.44
(.31 to .63)
2.Secondary Outcome
Title Overall Response Rate
Hide Description Overall response rate is defined as proportion of patients who achieve complete remission [CR, unconfirmed CR (CRu) or Functional CR] or partial remission. Response is assessed using the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma (Chesen, 1999).
Time Frame Assessed after cycle 3, cycle 6, and cycle 8 (if given).
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated
Arm/Group Title Treatment (A-CHOP Followed by MA)
Hide Arm/Group Description:
Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion
0.90
(0.76 to 0.93)
3.Secondary Outcome
Title 3-Year Overall Survival
Hide Description 3-year overall survival is defined as the probability of patients surviving at 3 years from study entry.
Time Frame Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Treatment (A-CHOP Followed by MA)
Hide Arm/Group Description:
Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.39
(0.26 to 0.58)
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 Treatment (ACHOP Followed by MA)
Hide Arm/Group Description Adverse events in all treated patients regardless of eligibility.
All-Cause Mortality
Treatment (ACHOP Followed by MA)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (ACHOP Followed by MA)
Affected / at Risk (%)
Total   34/44 (77.27%) 
Blood and lymphatic system disorders   
Anemia  1  3/44 (6.82%) 
Febrile neutropenia  1  8/44 (18.18%) 
Cardiac disorders   
Ventricular arrhythmia  1  1/44 (2.27%) 
Left ventricular systolic dysfunction  1  4/44 (9.09%) 
Restrictive cardiomyopathy  1  1/44 (2.27%) 
Gastrointestinal disorders   
Colitis  1  1/44 (2.27%) 
Constipation  1  1/44 (2.27%) 
Diarrhea  1  1/44 (2.27%) 
Mucositis oral  1  1/44 (2.27%) 
Colonic perforation  1  1/44 (2.27%) 
Intra-abdominal hemorrhage  1  1/44 (2.27%) 
Esophageal pain  1  1/44 (2.27%) 
General disorders   
Fatigue  1  6/44 (13.64%) 
Death NOS  1  1/44 (2.27%) 
Infections and infestations   
Infections and infestations - Other, spe  1  2/44 (4.55%) 
Infections and infestations - Other, spe  1  1/44 (2.27%) 
Lung infection  1  1/44 (2.27%) 
Anorectal infection  1  1/44 (2.27%) 
Urinary tract infection  1  1/44 (2.27%) 
Investigations   
White blood cell decreased  1  14/44 (31.82%) 
Lymphocyte count decreased  1  12/44 (27.27%) 
Neutrophil count decreased  1  23/44 (52.27%) 
Platelet count decreased  1  5/44 (11.36%) 
Weight loss  1  1/44 (2.27%) 
Aspartate aminotransferase increased  1  1/44 (2.27%) 
Blood bilirubin increased  1  1/44 (2.27%) 
Investigations - Other, specify  1  1/44 (2.27%) 
Metabolism and nutrition disorders   
Dehydration  1  1/44 (2.27%) 
Hyperglycemia  1  2/44 (4.55%) 
Hypophosphatemia  1  2/44 (4.55%) 
Hyponatremia  1  4/44 (9.09%) 
Nervous system disorders   
Peripheral sensory neuropathy  1  1/44 (2.27%) 
Headache  1  1/44 (2.27%) 
Reproductive system and breast disorders   
Vaginal inflammation  1  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/44 (2.27%) 
Dyspnea  1  2/44 (4.55%) 
Hypoxia  1  1/44 (2.27%) 
Vascular disorders   
Hypertension  1  4/44 (9.09%) 
Hypotension  1  1/44 (2.27%) 
Thromboembolic event  1  3/44 (6.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (ACHOP Followed by MA)
Affected / at Risk (%)
Total   39/44 (88.64%) 
Blood and lymphatic system disorders   
Anemia  1  15/44 (34.09%) 
Eye disorders   
Watering eyes  1  3/44 (6.82%) 
Gastrointestinal disorders   
Constipation  1  14/44 (31.82%) 
Diarrhea  1  9/44 (20.45%) 
Abdominal distension  1  4/44 (9.09%) 
Gastritis  1  4/44 (9.09%) 
Dyspepsia  1  9/44 (20.45%) 
Mucositis oral  1  13/44 (29.55%) 
Mucositis oral  1  5/44 (11.36%) 
Nausea  1  15/44 (34.09%) 
Vomiting  1  8/44 (18.18%) 
Abdominal pain  1  4/44 (9.09%) 
General disorders   
Fatigue  1  29/44 (65.91%) 
Fever  1  4/44 (9.09%) 
Edema limbs  1  4/44 (9.09%) 
Investigations   
White blood cell decreased  1  7/44 (15.91%) 
Lymphocyte count decreased  1  8/44 (18.18%) 
Neutrophil count decreased  1  6/44 (13.64%) 
Platelet count decreased  1  7/44 (15.91%) 
Weight loss  1  12/44 (27.27%) 
Alkaline phosphatase increased  1  6/44 (13.64%) 
Alanine aminotransferase increased  1  3/44 (6.82%) 
Aspartate aminotransferase increased  1  4/44 (9.09%) 
Investigations - Other, specify  1  3/44 (6.82%) 
Metabolism and nutrition disorders   
Anorexia  1  12/44 (27.27%) 
Hypoalbuminemia  1  4/44 (9.09%) 
Hypocalcemia  1  3/44 (6.82%) 
Hyperglycemia  1  19/44 (43.18%) 
Hypokalemia  1  6/44 (13.64%) 
Hyponatremia  1  7/44 (15.91%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  3/44 (6.82%) 
Myalgia  1  6/44 (13.64%) 
Nervous system disorders   
Dysgeusia  1  6/44 (13.64%) 
Dizziness  1  3/44 (6.82%) 
Peripheral sensory neuropathy  1  24/44 (54.55%) 
Headache  1  5/44 (11.36%) 
Psychiatric disorders   
Insomnia  1  6/44 (13.64%) 
Renal and urinary disorders   
Proteinuria  1  6/44 (13.64%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  4/44 (9.09%) 
Epistaxis  1  4/44 (9.09%) 
Bronchopulmonary hemorrhage  1  6/44 (13.64%) 
Pharyngolaryngeal pain  1  3/44 (6.82%) 
Cough  1  3/44 (6.82%) 
Dyspnea  1  7/44 (15.91%) 
Voice alteration  1  3/44 (6.82%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  3/44 (6.82%) 
Dry skin  1  5/44 (11.36%) 
Alopecia  1  17/44 (38.64%) 
Nail loss  1  4/44 (9.09%) 
Rash maculo-papular  1  4/44 (9.09%) 
Vascular disorders   
Hypertension  1  5/44 (11.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
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
Layout table for additonal information
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00217425     History of Changes
Other Study ID Numbers: CDR0000441194
U10CA021115 ( U.S. NIH Grant/Contract )
E2404 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
First Submitted: September 20, 2005
First Posted: September 22, 2005
Results First Submitted: February 20, 2014
Results First Posted: May 7, 2014
Last Update Posted: May 7, 2014