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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA096888 | U.S. NIH Grant/Contract | View source | |
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| NA_00035765 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or leukemia.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CVP + HiCy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgrastim | Biological | 5 mcg/kg/day starting on Day 3 after each R-CVP cycle and on Day 6 after HiCy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Number of participants who have a complete or partial remission (2007 International Working Group criteria). | Up to 3 months |
| Overall Survival | Percentage of participants alive at 1 year and at 3 years. | 1 year and 3 years |
| Event-free Survival | Percentage of participants alive without relapse at 1 year and 3 years. | 1 year and 3 years |
| Percentage of Participants Experiencing Grade 3-5 Toxicity | Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria). | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Pattern | Percentage of participants experiencing central nervous system (CNS) and systemic relapse. | Up to 6 months |
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Classic, sporadic Burkitt's lymphoma
Burkitt's leukemia (FAB L3 acute lymphoblastic leukemia)
Atypical Burkitt/Burkitt's-like lymphoma or leukemia, defined by the following criteria:
Any stage allowed
Newly diagnosed or untreated disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy for lymphoma
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Yvette L. Kasamon, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22835045 | Result | Kasamon YL, Brodsky RA, Borowitz MJ, Ambinder RF, Crilley PA, Cho SY, Tsai HL, Smith BD, Gladstone DE, Carraway HE, Huff CA, Matsui WH, Bolanos-Meade J, Jones RJ, Swinnen LJ. Brief intensive therapy for older adults with newly diagnosed Burkitt or atypical Burkitt lymphoma/leukemia. Leuk Lymphoma. 2013 Mar;54(3):483-90. doi: 10.3109/10428194.2012.715346. Epub 2012 Aug 17. |
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2 participants were found to be HIV+ after initiating the study and are considered to be screen failures as defined by the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rituximab | Biological | 375 mg/m^2 on Day 1 and Day 8 of each R-CVP cycle. 375 mg/m^2 on Day -4 of HiCy and weekly for four weeks after HiCy. |
|
|
| Cyclophosphamide | Drug | 1500 mg/m^2 on Day 1 of each R-CVP cycle. 50 mg/kg/day on Days -3, -2, -1, and 0 of HiCy. |
|
|
| Cytarabine | Drug | 100 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP. |
|
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| Methotrexate | Drug | 3 g/m^2 on Day 8 of each cycle of R-CVP. |
|
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| Prednisone | Drug | 100 mg on Days 1-5 of each cycle of R-CVP. |
|
|
| Hydrocortisone | Drug | 50 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP. |
|
| Vincristine | Drug | 1.4 mg/m^2 on Day 1 of each cycle of R-CVP. |
|
|
| Leucovorin | Drug | 25 mg four times daily after methotrexate administration. Dosing continues until adequate methotrexate levels are reached. |
|
|
| Drexel University College of Medicine - Center City Hahnemann Campus |
| Philadelphia |
| Pennsylvania |
| 19102 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate | Number of participants who have a complete or partial remission (2007 International Working Group criteria). | The 4 participants who died during treatment were not analyzed for this outcome. | Posted | Count of Participants | Participants | Up to 3 months |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Overall Survival | Percentage of participants alive at 1 year and at 3 years. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year and 3 years |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Event-free Survival | Percentage of participants alive without relapse at 1 year and 3 years. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year and 3 years |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing Grade 3-5 Toxicity | Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria). | Posted | Count of Participants | Participants | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Relapse Pattern | Percentage of participants experiencing central nervous system (CNS) and systemic relapse. | The 4 participants who died during treatment were not analyzed for this outcome. | Posted | Count of Participants | Participants | Up to 6 months |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 9 | 21 | 12 | 21 | 21 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ascites | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blood infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - chest | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Somnolence | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Subdural hematoma | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wound complication | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anasarca | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blurred vision | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Cough | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Deep vein thrombosis | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Drowsiness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Facial droop | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hallucination | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| High alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
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| High ALT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| High AST | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Incontinence | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lightheadedness | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - general | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - abdomen | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - chest | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - foot | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - hip | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - leg | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - neck | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombocytopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Transfusion reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginal bleeding | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weakness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Xerostomia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yvette Kasamon, MD | Johns Hopkins University | ykasamon@jhmi.edu |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D008727 | Methotrexate |
| D011241 | Prednisone |
| D006854 | Hydrocortisone |
| D014750 | Vincristine |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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Not provided
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