Trial Outcomes & Findings for Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia (NCT NCT00133991)

NCT ID: NCT00133991

Last Updated: 2018-09-17

Results Overview

Number of participants who have a complete or partial remission (2007 International Working Group criteria).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: Up to 3 months
• Results posted on: 2018-09-17

Participant Flow

2 participants were found to be HIV+ after initiating the study and are considered to be screen failures as defined by the protocol.

Participant milestones

Measure	R-CVP + HiCy 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 Study STARTED	21
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	R-CVP + HiCy 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 Study Death	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	R-CVP + HiCy n=21 Participants 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Age, Continuous	53 years n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Population: The 4 participants who died during treatment were not analyzed for this outcome.

Number of participants who have a complete or partial remission (2007 International Working Group criteria).

Outcome measures

Measure	R-CVP + HiCy n=17 Participants 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 Response Rate Complete remission	11 Participants
Overall Response Rate Partial remission	2 Participants

PRIMARY outcome

Timeframe: 1 year and 3 years

Percentage of participants alive at 1 year and at 3 years.

Outcome measures

Measure	R-CVP + HiCy n=21 Participants 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 Survival 1 year	57 percentage of participants Interval 40.0 to 83.0
Overall Survival 3 years	57 percentage of participants Interval 40.0 to 83.0

PRIMARY outcome

Timeframe: 1 year and 3 years

Percentage of participants alive without relapse at 1 year and 3 years.

Outcome measures

Measure	R-CVP + HiCy n=21 Participants 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.
Event-free Survival 1 year	52 percentage of participants Interval 35.0 to 79.0
Event-free Survival 3 years	52 percentage of participants Interval 35.0 to 79.0

PRIMARY outcome

Timeframe: Up to 2 years

Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria).

Outcome measures

Measure

R-CVP + HiCy n=21 Participants 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.

Percentage of Participants Experiencing Grade 3-5 Toxicity

21 Participants

SECONDARY outcome

Timeframe: Up to 6 months

Population: The 4 participants who died during treatment were not analyzed for this outcome.

Percentage of participants experiencing central nervous system (CNS) and systemic relapse.

Outcome measures

Measure	R-CVP + HiCy n=17 Participants 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.
Relapse Pattern Systemic relapse only	3 Participants
Relapse Pattern Systemic and CNS relapse	2 Participants

Adverse Events

R-CVP + HiCy

Serious events: 12 serious events

Other events: 21 other events

Deaths: 9 deaths

Serious adverse events

Measure	R-CVP + HiCy n=21 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Hepatobiliary disorders Ascites	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Atrial fibrillation	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Infections and infestations Blood infection	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Gastrointestinal disorders Colitis	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Infections and infestations Encephalitis	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Infections and infestations Febrile neutropenia	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Hypotension	4.8% 1/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Pain - chest	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Pericarditis	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Infections and infestations Pneumonia	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Infections and infestations Sepsis	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
General disorders Somnolence	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Stroke	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Subdural hematoma	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Metabolism and nutrition disorders Tumor lysis syndrome	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Wound complication	4.8% 1/21 • Number of events 1 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.

Other adverse events

Measure	R-CVP + HiCy n=21 participants at risk 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.
Immune system disorders Allergic reaction	14.3% 3/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
General disorders Anasarca	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Anemia	14.3% 3/21 • Number of events 6 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Atrial fibrillation	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Blurred vision	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Bradycardia	9.5% 2/21 • Number of events 4 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
General disorders Chills	14.3% 3/21 • Number of events 5 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Confusion	14.3% 3/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Gastrointestinal disorders Constipation	42.9% 9/21 • Number of events 19 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
General disorders Cough	14.3% 3/21 • Number of events 5 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Gastrointestinal disorders Anorexia	14.3% 3/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Deep vein thrombosis	14.3% 3/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Gastrointestinal disorders Diarrhea	28.6% 6/21 • Number of events 12 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Dizziness	19.0% 4/21 • Number of events 7 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Drowsiness	9.5% 2/21 • Number of events 4 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Gastrointestinal disorders Dysphagia	9.5% 2/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Respiratory, thoracic and mediastinal disorders Dyspnea	47.6% 10/21 • Number of events 18 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Edema	23.8% 5/21 • Number of events 10 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Facial droop	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
General disorders Fatigue	33.3% 7/21 • Number of events 13 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Infections and infestations Febrile neutropenia	28.6% 6/21 • Number of events 8 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Infections and infestations Fever	28.6% 6/21 • Number of events 14 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Hallucination	9.5% 2/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
General disorders Headache	52.4% 11/21 • Number of events 27 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Renal and urinary disorders Hematuria	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations High alkaline phosphatase	9.5% 2/21 • Number of events 7 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations High ALT	14.3% 3/21 • Number of events 9 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations High AST	23.8% 5/21 • Number of events 14 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Hyperbilirubinemia	23.8% 5/21 • Number of events 14 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Hyperglycemia	14.3% 3/21 • Number of events 11 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Hypertension	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Hypoalbuminemia	9.5% 2/21 • Number of events 5 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Hypocalcemia	14.3% 3/21 • Number of events 7 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Hypokalemia	14.3% 3/21 • Number of events 7 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Hypophosphatemia	9.5% 2/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Hypotension	33.3% 7/21 • Number of events 23 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Respiratory, thoracic and mediastinal disorders Hypoxia	28.6% 6/21 • Number of events 12 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Incontinence	14.3% 3/21 • Number of events 7 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Infections and infestations Infection	23.8% 5/21 • Number of events 8 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Insomnia	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Leukopenia	38.1% 8/21 • Number of events 42 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Lightheadedness	19.0% 4/21 • Number of events 5 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Lymphopenia	19.0% 4/21 • Number of events 26 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Gastrointestinal disorders Mucositis	9.5% 2/21 • Number of events 7 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Gastrointestinal disorders Nausea	28.6% 6/21 • Number of events 18 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Neuropathy	42.9% 9/21 • Number of events 19 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Neutropenia	23.8% 5/21 • Number of events 17 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Pain - general	14.3% 3/21 • Number of events 4 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Pain - abdomen	33.3% 7/21 • Number of events 12 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Pain - back	42.9% 9/21 • Number of events 15 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Pain - chest	19.0% 4/21 • Number of events 4 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Pain - foot	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Pain - hip	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Pain - leg	23.8% 5/21 • Number of events 5 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Musculoskeletal and connective tissue disorders Pain - neck	14.3% 3/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Infections and infestations Pneumonia	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Skin and subcutaneous tissue disorders Rash	14.3% 3/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Renal and urinary disorders Renal failure	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Somnolence	9.5% 2/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Skin and subcutaneous tissue disorders Sweating	19.0% 4/21 • Number of events 4 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Cardiac disorders Tachycardia	9.5% 2/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Investigations Thrombocytopenia	28.6% 6/21 • Number of events 36 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Infections and infestations Thrush	19.0% 4/21 • Number of events 5 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Immune system disorders Transfusion reaction	14.3% 3/21 • Number of events 4 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Renal and urinary disorders Urinary frequency	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Renal and urinary disorders Urinary retention	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Reproductive system and breast disorders Vaginal bleeding	9.5% 2/21 • Number of events 2 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Gastrointestinal disorders Vomiting	33.3% 7/21 • Number of events 20 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Nervous system disorders Weakness	14.3% 3/21 • Number of events 11 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Respiratory, thoracic and mediastinal disorders Wheezing	14.3% 3/21 • Number of events 7 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.
Gastrointestinal disorders Xerostomia	9.5% 2/21 • Number of events 3 • Up to 2 years Adverse events were tracked monthly through the completion of study intervention and then every three months for up to two years total.

Additional Information

Yvette Kasamon, MD

Johns Hopkins University

Email: ykasamon@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place