Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01251 | Registry Identifier | NCI Clinical Trial Registration Program |
Not provided
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This is a phase III clinical trial using risk-adapted therapy. Treatment outcomes for children with B-cell NHL are excellent. Further improvements in outcome will likely be achieved through more focused study of the biology of the tumors and prospective studies of the late effects of treatment. Toward this end, this study features a spectrum of prospective biologic and late effect studies performed in patients treated with a modified regimen derived from the very successful LMB-96 regimen.
Exploratory Aims:
To estimate the complete response rate, event-free survival, and overall survival rates in patients with Burkitt lymphoma (BL), Burkitt leukemia/B-cell acute leukemia (B-ALL) and diffuse large B-cell lymphoma (DLBCL) treated with a stage-adapted regimen based on the St. Jude B-cell II protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Completely resected stage I or completely resected abdominal stage II lesions. Group A will include: COPAD x 2 cycles. |
|
| Group B | Other | All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV) Group B will include the intervention COP, COPD M3, CYM as follows: Pre-Phase: COP Induction: COPAD M3 x 2 cycles Consolidation: CYM x 2 cycles. |
|
| Group C | Other | Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies:
Group C will include the intervention COP, COPADM8, CYVE as follows: Pre-Phase: COP Induction: COPADM8 cycle 1 Induction: COPADM8 Cycle 2 Consolidation: CYVE x 2 cycles and Maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPAD | Drug | Vincristine Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gene Differential Expression Profiling of Burkitt Lymphoma (BL) vs. Non-BL in the US and Other Selected Geographic Regions of the World | Gene expression levels in BL vs. non-BL will be analyzed through approximately 22,000 probesets on the Affymetrix U133A GeneChip by using two-factor analysis of variance model for each gene. | 1 year after the participant is enrolled |
| Catalog and Estimate Frequencies of Copy Number Variations in Childhood Lymphomas | The prevalence of CNVs between different subtypes of childhood lymphomas and geographic regions will be reported and compared with exact chi-square or Fisher's test. The CNVs are derived from Affymetrix SNP arrays. | 1 year after the participant is enrolled |
| Integrated Analysis of CNVs and Gene Expressions in the US and Other Selected Geographic Regions of the World | The association between the identified CNVs and gene expressions in the study cohort will be examined by using general linear models, and multiple tests will be considered. Gene expressions are measured by Affymetrix U133A arrays and CNVs are derived from Affymetrix SNP arrays. | 1 year after the participant is enrolled |
| Pattern and Frequency of XLP Gene Mutations Presenting With B-cell Lymphomas in the United States and Selected Geographic Regions | Frequency of XLP mutation among boys will be calculated in each geographical region as well as in all regions pooled. The frequency is reported here as the number of boys with XLP gene mutations found in B-cell lymphomas boys. | 1 year after the participant enrollment |
| Frequency of EBV Protein Expression (e.g., EBNA 3) in EBV-positive Lymphomas | Frequency of EBV-positive BL will be calculated for each geographical region. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) will be estimated among eligible patients treated at SJCRH by the Kaplan-Meier estimator. | Up to 5 years after completion of therapy |
| Event-free Survival | Event-free survival (EFS) will be estimated among eligible patients treated at SJCRH by the Kaplan-Meier estimator. The events will include: (1) death while in continuous CR, (2) relapse, (3) secondary malignancy, and (4) failure to achieve complete response (CR). |
Inclusion Criteria:
St. Jude participants and collaborating sites participating in therapeutic and biological objectives:
Participant must have a histologic diagnosis of a mature B cell lymphoma (e.g., Burkitt lymphoma/leukemia, atypical Burkitt lymphoma, diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, mature B-cell lymphoma NOS) as defined in the WHO classification.
Participant must be previously untreated, (no more than 72 hours of steroids, one intrathecal chemotherapy treatment, and/or emergency radiation).
Participant must be < 22 years of age at the time of diagnosis
For selected higher-risk CD20+ Group B and all CD20+ Group C participants receiving rituximab only (e.g., those with MLBLC, Stage III with LDH ≥ 2 times upper limit of normal (ULN), and/or bone marrow/CNS involvement: All participants who will receive rituximab must have hepatitis screening prior to enrollment. Participants whose results indicate that they are carrier of hepatitis B can still be treated per Group B or C but will NOT receive rituximab. This screening must be done for eligibility for participants who will receive rituximab, BUT the results are not needed prior to enrollment:
All participants must have screening prior to enrollment; participants whose results indicate that they are carrier of hepatitis B can still be treated per group B and C but will NOT receive rituximab
HIV test has been obtained within 42 days. Participants who test positive for HIV cannot be enrolled on therapeutic part of study, but are still eligible for biology studies.
Informed consent must be obtained according to St. Jude guidelines before enrollment into study.
Participants from Collaborating Sites Participating in Biological Objectives Only:
Exclusion Criteria:
Participants from Collaborating Sites Participating in Therapeutic and Biological Objectives:
Participants from Collaborating Sites Participating in Biological Objectives Only:
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| Name | Affiliation | Role |
|---|---|---|
| Raul Ribeiro, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital San Diego | San Diego | California | 92123 | United States | ||
| St. Jude Children's Research Hospital |
Not provided
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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115 patients were recruited between 15APR1309Sept2010 and 31AUG2022. One patient died at the same day he was enrolled and did not start any treatment and risk was not determined and was excluded in the treatment outcome analysis. One was found to be ineligible after the start of treatment.
Thirteen participants from diverse geographical regions were enrolled in the biology only part of the study and no outcome data is available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Completely resected stage I or completely resected abdominal stage II lesions. |
| FG001 | Group B | All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV) |
| FG002 | Group C | Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies:
|
| FG003 | Unknown Risk | Patient died prior to treatment and risk assignment |
| FG004 | Biology Only | Participants enrolled on the biology only arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 87 participants that started in Group B, one was found to be ineligible and is excluded from all analysis, including adverse events.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Completely resected stage I or completely resected abdominal stage II lesions. |
| BG001 | Group B | All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Gene Differential Expression Profiling of Burkitt Lymphoma (BL) vs. Non-BL in the US and Other Selected Geographic Regions of the World | Gene expression levels in BL vs. non-BL will be analyzed through approximately 22,000 probesets on the Affymetrix U133A GeneChip by using two-factor analysis of variance model for each gene. | No data was generated for this measure due to the PI leaving St. Jude, COVID-19 disruptions, stricter regulations on international tumor material shipping, and unavailability of the required assay platform. One sample was received from Singapore, none from Egypt. No participant is analyzed, and no gene expression data is generated because the Affymetrix U133A GeneChip is no longer available. No participant will be analyzed, and no gene expression data will be generated in the future. | Posted | 1 year after the participant is enrolled |
|
Acute adverse events were collected from each participant's on-study date through the end of therapy, through study completion, an average of 8 months. The timeframe for All-Cause Mortality is from start of therapy up to 5 years after completion of therapy.
The "unknown risk patient" was consented and died prior to risk assignment or starting therapy. No additional adverse event data was captured.
The "Biology Only" group only provide samples and were not treated on this protocol. No adverse event data was captured on these participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Completely resected stage I or completely resected abdominal stage II lesions. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raul Ribeiro, MD | St. Jude Children's Research Hospital | 901-595-3694 | raul.ribeiro@stjude.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2022 | Aug 26, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011241 | Prednisone |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D000069585 | Filgrastim |
| C455861 | pegfilgrastim |
| C469709 | rasburicase |
| D002955 | Leucovorin |
| D000069283 | Rituximab |
| D003561 | Cytarabine |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| COP, COPD M3, CYM | Drug | GROUP B Treatment Details Intravenous fluids should be given at a rate of 3000 mL/m2/day. Use of rasburicase may preclude the need for HCO3 Pre-Phase: Cyclophosphamide, Vincristine, Prednis(ol)one, IT medications Induction (2 cycles): Vincristine, Prednis(ol)one, Methotrexate, Leucovorin, Cyclophosphamide, Doxorubicin, IT medications, G-CSF, Rituximab Consolidation (2 cycles): Methotrexate, Leucovorin, Cytarabine, IT medications, G-CSF, Rituximab In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted. |
|
|
| COP, COPADM8, CYVE | Drug | Treatment: Intravenous fluids should be given at a rate of 3000 mL/m2/day. Use of rasburicase may preclude the need for HCO3. COP Pre-Phase: Cyclophosphamide, Vincristine, Prednis(ol)one, IT medications, Leucovorin. COPADM8 Induction (2 cycles): Vincristine, Prednis(ol)one, Methotrexate, Leucovorin, Cyclophosphamide, Doxorubicin, Rituximab, IT medications, G-CSF CYVE Consolidation (2 cycles): Cytarabine, High-Dose Ara-C, Etoposide, Rituximab, G-CSF. Maintenance No.1: Vincristine, Prednis(ol)one, Cyclophosphamide, Methotrexate, Leucovorin, Doxorubicin, IT medications, G-CSF. Maintenance No.2: Cytarabine, Etoposide, G-CSF, IT Medications. Maintenance No.3: Vincristine, Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF, IT Medications. Maintenance No. 4: Cytarabine, Etoposide, G-CSF, IT Medications. In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted. |
|
|
| 1 year after the participant is enrolled |
| Up to 5 years after completion of therapy |
| Complete Response Rate | Complete response rate will be estimated with exact 95% CI based on the binomial distribution, and it will be reported as the percentage of patients who reached complete remission among eligible patients treated at SJCRH | Up to 5 years after completion of therapy |
| Memphis |
| Tennessee |
| 38105 |
| United States |
| Children's Cancer Hospital | Cairo | 11787 | Egypt |
| National University Health System | Singapore | 119228 | Singapore |
| Physician Decision |
|
| Participant or family decision to withdraw from protocol treatment |
|
| Found to be ineligible |
|
| Death |
|
| Did not submit biology samples |
|
| BG002 | Group C | Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies:
|
| BG003 | Biology Only | Participants enrolled on the biology only arm |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
US Participants Biology Samples
| OG001 | Biology Samples-Singapore | Singapore Participants Biology Samples |
| OG002 | Biology Samples-Egypt | Egypt Participants Biology Samples |
|
| Primary | Catalog and Estimate Frequencies of Copy Number Variations in Childhood Lymphomas | The prevalence of CNVs between different subtypes of childhood lymphomas and geographic regions will be reported and compared with exact chi-square or Fisher's test. The CNVs are derived from Affymetrix SNP arrays. | We were unable to evaluate this measure due to challenges such as the PI leaving St. Jude, COVID-19 disruptions, stricter regulations on shipping tumor materials internationally, and unavailability of the required assay platform. One sample was received from Singapore, none from Egypt. No participant is analyzed, and no CNV data is generated because the Affymetrix SNPChip platform is no longer available. No participant will be analyzed, and no CNV data will be generated in the future. | Posted | 1 year after the participant is enrolled |
|
|
| Primary | Integrated Analysis of CNVs and Gene Expressions in the US and Other Selected Geographic Regions of the World | The association between the identified CNVs and gene expressions in the study cohort will be examined by using general linear models, and multiple tests will be considered. Gene expressions are measured by Affymetrix U133A arrays and CNVs are derived from Affymetrix SNP arrays. | No data was generated for this measure due to PI leaving St. Jude, COVID-19 disruptions, stricter regulations on international tumor material shipping , unavailability of the required assay platform. 1 sample was received from Singapore, 0 from Egypt. No participant is analyzed, and no gene expression and CNV data is generated because the Affymetrix U133A GeneChip and SNPChip are unavailable. No participant will be analyzed, and no gene expression and CNV data will be generated in the future. | Posted | 1 year after the participant is enrolled |
|
|
| Primary | Pattern and Frequency of XLP Gene Mutations Presenting With B-cell Lymphomas in the United States and Selected Geographic Regions | Frequency of XLP mutation among boys will be calculated in each geographical region as well as in all regions pooled. The frequency is reported here as the number of boys with XLP gene mutations found in B-cell lymphomas boys. | We cannot obtain samples from other countries; thus cannot evaluate this objective, due to the PI leaving, difficulties caused by COVID-19, and, most importantly, changes in regulations on sending tumor material from institutions in other countries. We received 1 sample from Singapore and none from Egypt. For international sites, no clinical, laboratory or outcome features are available. Among US samples, 1 was tested XLP positive. No data was generated from the Singapore sample. | Posted | Count of Participants | Participants | 1 year after the participant enrollment |
|
|
|
| Primary | Frequency of EBV Protein Expression (e.g., EBNA 3) in EBV-positive Lymphomas | Frequency of EBV-positive BL will be calculated for each geographical region. | We were unable to fully evaluate this measure due to PI leaving St. Jude, COVID-19 disruptions, and stricter regulations on sending tumor material from other countries. We received 5 participants at our institution and none showed EBV positivity. No sample was received from international sites. No EBV positivity test will be performed, and no further data will be generated in the future. | Posted | Count of Participants | Participants | 1 year after the participant is enrolled |
|
|
|
| Other Pre-specified | Overall Survival | Overall survival (OS) will be estimated among eligible patients treated at SJCRH by the Kaplan-Meier estimator. | The study objective requires to obtain and analyze long-term outcome (OS and EFS) and toxicities in Groups A, B, C only. Patients in the "Biology Only" group only provide samples and are not treated on this protocol. Therefore EFS, OS and toxicities are only analysed and reported for Groups A, B and C. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 5 years after completion of therapy |
|
|
|
|
| Other Pre-specified | Event-free Survival | Event-free survival (EFS) will be estimated among eligible patients treated at SJCRH by the Kaplan-Meier estimator. The events will include: (1) death while in continuous CR, (2) relapse, (3) secondary malignancy, and (4) failure to achieve complete response (CR). | The study objective requires to obtain and analyze long-term outcome (OS and EFS) and toxicities in Groups A, B, C only. Patients in the "Biology Only" group only provide samples and are not treated on this protocol. Therefore EFS, OS and toxicities are only analysed and reported for Groups A, B and C. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 5 years after completion of therapy |
|
|
|
|
| Other Pre-specified | Complete Response Rate | Complete response rate will be estimated with exact 95% CI based on the binomial distribution, and it will be reported as the percentage of patients who reached complete remission among eligible patients treated at SJCRH | Only the 89 patients treated at St. Jude Children's Hospital are included in this analysis.The study objective requires to obtain and analyze long-term outcome (OS and EFS) and toxicities in Groups A, B, C only. Patients in the "Biology Only" group only provide samples and are not treated on this protocol. Therefore EFS, OS and toxicities are only analysed and reported for Groups A, B and C. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 5 years after completion of therapy |
|
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | Group B | All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV) | 1 | 86 | 0 | 86 | 77 | 86 |
| EG002 | Group C | Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies:
| 1 | 22 | 0 | 22 | 21 | 22 |
| EG003 | Unknown Risk | Patient died prior to treatment and risk assignment | 1 | 1 | 0 | 0 | 0 | 0 |
| Mucositis oral | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Tumor lysis syndrome | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Fever | General disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Anal mucositis | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| White blood cell decreased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | NCI CTCAE v4.0 | Systematic Assessment |
|
| Typhlitis | Gastrointestinal disorders | NCI CTCAE v4.0 | Systematic Assessment |
|
MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| 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 |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |