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The investigators propose to use Belinostat in combination with AZT as consolidation therapy for the treatment of ATLL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belinostat + Zidovudine | Experimental | Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belinostat | Drug | Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1- 5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR) | Number of participants achieving Complete Molecular Response after receiving protocol therapy will be reported. Complete Molecular Response (CMR) is defined as the disappearance of malignant clone(s), as proven by negative T-cell receptor gene rearrangement studies of peripheral blood DNA and bone marrow. CMR will be evaluated based upon T-cell clonality studies to be conducted while subjects are on Belinostat, and while subjects are receiving Zidovudine (AZT)-based maintenance treatment (after Belinostat completion). | From end of cycle 3 until at least end of month 12 |
| Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Number of participants experiencing treatment-related serious adverse events (SAEs), and adverse events (AEs). SAEs and AEs will be assessed by and assigned severity and treatment attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03. | Up to 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Clinical Response | Number of participants achieving complete response (CR) or partial response (PR) to study therapy will be reported. Response is assessed on the basis of clinical, radiologic, molecular and pathologic (i.e. bone marrow) criteria. | Up to 12 months |
| Failure-Free Survival (FFS) Rate at 12 Months Using Kaplan-Meier Method |
Not provided
Inclusion Criteria:
Histologically or cytologically documented adult T-cell leukemia/lymphoma (ATLL) with the following characteristics:
One of the following:
Presence of ATLL based on morphology, histology, flow cytometry, or T-cell clonality in peripheral blood during screening period prior enrollment.
Documented Human T-cell lymphotropic virus type 1 (HTLV-1) infection: Documentation may be serologic assay (ELISA) confirmed by Western blot or polymerase chain reaction (PCR).
Measurable or evaluable disease, including presence of ATLL by immunophenotyping from either histology or flow cytometry studies, or molecular disease as evidence by T-cell clonality detected by gene rearrangement studies.
18 years of age or older.
Karnofsky performance status (KPS) ≥ 50% or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
Patients must have adequate end organ and bone marrow function as defined below:
absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 [Exception: Unless cytopenias are secondary to ATLL]
platelets (PLT) ≥ 50,000 cells/mm3 [Exception: Unless cytopenias are secondary to ATLL]
Adequate hepatic function:
Creatinine clearance (CrCl) ≥ 40 mL/min, [Exception: Unless secondary to renal involvement by lymphoma is suspected.]
Patients who are human immunodeficiency virus positive (HIV+) are also eligible.
Females of childbearing potential (CBP) must have a negative serum pregnancy test within one week of enrollment. Women should avoid pregnancy while receiving study treatment. Males and females must agree to use adequate birth control during participation in this trial and for 3 months after completing therapy.
Patients receiving erythropoietin or Granulocyte-colony stimulating factor (G-CSF) from baseline are eligible.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan C Ramos, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Belinostat + Zidovudine | Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b) Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles. Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12. Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Belinostat + Zidovudine | Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b) Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles. Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12. Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy. |
| 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 |
| 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 | Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR) | Number of participants achieving Complete Molecular Response after receiving protocol therapy will be reported. Complete Molecular Response (CMR) is defined as the disappearance of malignant clone(s), as proven by negative T-cell receptor gene rearrangement studies of peripheral blood DNA and bone marrow. CMR will be evaluated based upon T-cell clonality studies to be conducted while subjects are on Belinostat, and while subjects are receiving Zidovudine (AZT)-based maintenance treatment (after Belinostat completion). | Participants that have received at least three (3) doses of Belinostat and Zidovudine (AZT) consolidation therapy, have evaluable disease at baseline, and at least one post-baseline molecular disease assessment. | Posted | Count of Participants | Participants | From end of cycle 3 until at least end of month 12 |
|
13 months
Not provided
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 | Belinostat + Zidovudine | Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b) Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles. Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12. Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain - cardiac | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juan Carlos Ramos MD | University of Miami | 305-243-4860 | jramos2@med.miami.edu |
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 | Dec 23, 2025 | Dec 23, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015459 | Leukemia-Lymphoma, Adult T-Cell |
| ID | Term |
|---|---|
| D015458 | Leukemia, T-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C487081 | belinostat |
| D015215 | Zidovudine |
| D007438 | Introns |
| C417083 | peginterferon alfa-2b |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
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|
|
| Zidovudine | Drug | Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO), three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12. |
|
|
| Interferon-Alfa-2b | Drug | OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. |
|
|
| Pegylated Interferon-Alfa-2b | Drug | OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. |
|
|
| Lymphodepleting Therapy | Drug | OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy. |
|
|
The Failure-Free Survival (FFS) rate at 12 months estimated by the Kaplan-Meier method will be reported as a percentage probability of participants alive without documented disease progression, relapse after response or death (by any cause) at 12 months after starting study therapy. FFS is defined as the elapsed time in months from study treatment initiation until documented disease progression, relapse after response or death (by any cause, in the absence of progression). In the failure-free subjects, FFS will be censored at the last documented date of failure-free status. |
| 12 months |
| Overall Survival (OS) Rate at 12 Months Using Kaplan-Meier Method | The Overall Survival (OS) rate at 12 months estimated by the Kaplan-Meier method will be reported as the percentage probability of survival beyond 12 months. OS is defined as the elapsed time from study treatment initiation to death or date of censoring. Subjects alive or those lost to follow-up will be censored at the last date known to be alive. | 12 months |
| Number of Participants Exhibiting Disruption of HTLV-1 Latency in Vivo | The number of participants exhibiting disruption of Human T-lymphotropic virus 1 (HTLV-1) latency in vivo after receiving Belinostat therapy will be reported. HTLV-1 latency will be evaluated from serum blood samples. | Up to 13 months |
| Number of Participants Exhibiting Cytotoxic T-Cell Response in Vivo | The number of participants exhibiting cytotoxic T-Cell response in vivo after receiving Belinostat therapy will be reported. Cytotoxic T-Cell response will be evaluated from serum blood samples. | Up to 13 months |
| HTLV-1 Pro-Viral Load Among Participants | HTVL-1 pro-viral load among study participants will be reported as a measure of HTLV-1 infected reservoirs in vivo after receiving Belinostat therapy. HTLV-1 viral load will be evaluated from serum blood samples | Up to 13 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b) Belinostat: Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1-5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles. Zidovudine: Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO),three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12. Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. Pegylated Interferon-Alfa-2b: OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months. Lymphodepleting Therapy: OPTIONAL: For subjects with any increase in lymphocyte count. Cyclophosphamide administered as 375 mg/m2 via intravenous infusion once during Cycle 1 after Day 5 of Belinostat therapy. |
|
|
| Primary | Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events | Number of participants experiencing treatment-related serious adverse events (SAEs), and adverse events (AEs). SAEs and AEs will be assessed by and assigned severity and treatment attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03. | Participants that have received at least one dose of Belinostat and Zidovudine (AZT) consolidation therapy. | Posted | Number | participants | Up to 13 months |
|
|
|
| Secondary | Number of Participants Achieving Clinical Response | Number of participants achieving complete response (CR) or partial response (PR) to study therapy will be reported. Response is assessed on the basis of clinical, radiologic, molecular and pathologic (i.e. bone marrow) criteria. | Participants that receive at least one dose of Belinostat and Zidovudine (AZT) consolidation therapy, have evaluable disease at baseline, and at least one post-baseline clinical disease assessment. | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
| Secondary | Failure-Free Survival (FFS) Rate at 12 Months Using Kaplan-Meier Method | The Failure-Free Survival (FFS) rate at 12 months estimated by the Kaplan-Meier method will be reported as a percentage probability of participants alive without documented disease progression, relapse after response or death (by any cause) at 12 months after starting study therapy. FFS is defined as the elapsed time in months from study treatment initiation until documented disease progression, relapse after response or death (by any cause, in the absence of progression). In the failure-free subjects, FFS will be censored at the last documented date of failure-free status. | Participants that received at least one dose of Belinostat and Zidovudine (AZT) consolidation therapy. | Posted | Number | 95% Confidence Interval | percentage probability at 12 months | 12 months |
|
|
|
| Secondary | Overall Survival (OS) Rate at 12 Months Using Kaplan-Meier Method | The Overall Survival (OS) rate at 12 months estimated by the Kaplan-Meier method will be reported as the percentage probability of survival beyond 12 months. OS is defined as the elapsed time from study treatment initiation to death or date of censoring. Subjects alive or those lost to follow-up will be censored at the last date known to be alive. | Participants that received at least one dose of Belinostat and Zidovudine consolidation therapy. | Posted | Number | 95% Confidence Interval | percentage probability at 12 months | 12 months |
|
|
|
| Secondary | Number of Participants Exhibiting Disruption of HTLV-1 Latency in Vivo | The number of participants exhibiting disruption of Human T-lymphotropic virus 1 (HTLV-1) latency in vivo after receiving Belinostat therapy will be reported. HTLV-1 latency will be evaluated from serum blood samples. | Not Posted | Dec 2026 | Up to 13 months | Participants |
| Secondary | Number of Participants Exhibiting Cytotoxic T-Cell Response in Vivo | The number of participants exhibiting cytotoxic T-Cell response in vivo after receiving Belinostat therapy will be reported. Cytotoxic T-Cell response will be evaluated from serum blood samples. | Not Posted | Dec 2026 | Up to 13 months | Participants |
| Secondary | HTLV-1 Pro-Viral Load Among Participants | HTVL-1 pro-viral load among study participants will be reported as a measure of HTLV-1 infected reservoirs in vivo after receiving Belinostat therapy. HTLV-1 viral load will be evaluated from serum blood samples | Not Posted | Dec 2026 | Up to 13 months | Participants |
| 11 |
| 15 |
| 7 |
| 15 |
| 15 |
| 15 |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE 4.03 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE 4.03 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE 4.03 | Systematic Assessment |
|
| Alkalosis | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE 4.03 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment | Agranulocytosis |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment | Count eosinophils decrease |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment | Count lymphocytes increase |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment | Neutrophils count high |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment | Neutrophils count Increase |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment | Right Nose bleeding |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment | White blood cell increase |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE 4.03 | Systematic Assessment | White Blood Cell Increased |
|
| Bronchial infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
|
| Chills | General disorders | CTCAE 4.03 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Facial nerve disorder | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE 4.03 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE 4.03 | Systematic Assessment |
|
| Fever | General disorders | CTCAE 4.03 | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE 4.03 | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE 4.03 | Systematic Assessment | Cramps |
|
| General disorders and administration site conditions - Other, specify | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment | Nasal bleeding |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE 4.03 | Systematic Assessment | Lung Infection-Cytomegalovirus (CMV) |
|
| Injection site reaction | General disorders | CTCAE 4.03 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE 4.03 | Systematic Assessment |
|
| Intracranial hemorrhage | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
|
| Investigations - Other, specify | Investigations | CTCAE 4.03 | Systematic Assessment | Hypochloremia |
|
| Lung infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | CTCAE 4.03 | Systematic Assessment |
|
| Malaise | General disorders | CTCAE 4.03 | Systematic Assessment |
|
| Meningitis | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment | Metabolic and nutrition disorders - Not otherwise specified (NOS) |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment | Aspartate Aminotransferase (AST) Increased |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE 4.03 | Systematic Assessment | Hypochloremia |
|
| Mucosal infection | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment | Necrotizing Fasciitis, right lower extremity (RLE) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Pain | General disorders | CTCAE 4.03 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
|
| Papulopustular rash | Infections and infestations | CTCAE 4.03 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
|
| Pharyngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | CTCAE 4.03 | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE 4.03 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment | Skin Rash |
|
| Stomach pain | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE 4.03 | Systematic Assessment | Acute Pulmonary Embolism |
|
| Tremor | Nervous system disorders | CTCAE 4.03 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE 4.03 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE 4.03 | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE 4.03 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
|
| Grade 3 or 4 Treatment-Related SAEs: Non-Hematologic Events |
|
| Grade 1 or 2 Treatment-Related Adverse Events (AEs): Hematologic Events |
|
| Grade 1 or 2 Treatment-Related AEs: Non-Hematologic Events |
|
| Grade 3 or 4 Treatment-Related AEs: Hematologic Events |
|
| Grade 3 or 4 Treatment-Related AEs: Non-Hematologic Events |
|