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In the United States, thiotepa has been utilized in reduced intensity conditioning regimens for alternative donor courses (double umbilical cord blood transplant (dUCBT) and haplo-identical transplants).
The hypothesis is that thiotepa at a dose of 10mg/kg, in combination with melphalan (100mg/m2) and fludarabine (160mg/m2) as a reduced intensity conditioning regimen for alternative donor transplant is safe and effective in patients with hematologic malignancies.
Given that this regimen has been investigated extensively, and the current study proposes to confirm those previous observations with a small modification (melphalan dose reduction due to previous mucositis rates with higher doses), this will be a phase II study designed to measure disease-free-survival.
Primary Objective:
To assess the effectiveness of Thiotepa, Fludarabine, and Melphalan in alternative donor transplants as measured by leukemia free survival.
Secondary Objective:
To assess the 1- year OS, Relapse, TRM, aGVHD and cGVHD rates and the rates of neutrophil and platelet engraftment.
Study Design This is a Phase II study of Thiotepa, Fludarabine, and Melphalan in alternative donor transplants.
Subjects will be assessed for safety and tolerability (including adverse events, serious adverse events, and clinical/laboratory assessments) using a continuous monitoring approach. Subjects will be followed for up to 1 year or until progression of disease, relapse, or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thiotepa + Fludarabine + Melphalan | Experimental | Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melphalan | Drug | Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells. Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Disease Free Survival | Leukemia Free Survival (LFS) at 1 year is the percentage of patients alive and without evidence of hematologic malignancy at 1 year after transplant. | Up to 1 year after transplant |
| Percentage of Patients With Leukemia Free Survival | Up to 1 year after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Average Overall Survival | Overall Survival (OS) at 1 year is the percentage of patients alive at 1 year after transplant. | Up to 1 year after transplant |
| Relapse Incidence | Relapse incidence at 1 year is the percentage of patients who experience relapse of their hematologic malignancy up to 1 year after transplant. |
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Inclusion Criteria:
Patients with the following hematologic malignancies:
Acute myelogenous leukemia (AML): High-risk AML including:
Acute lymphoblastic leukemia (ALL)
High-risk CR1 including:
No CR within 4 weeks of initial treatment
Induction failure with ≤ 10% blasts in the marrow
CR2 or CR3
Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system (IPSS-R)
Mixed Phenotypic Leukemia / Biphenotypic Leukemiain CR
Chronic Myelogenous Leukemia (CML) in second chronic phase after accelerated or blast crisis.
Myelofibrosis (MF):
Chronic Myelomonocytic Leukemia
Relapsed or Refractory Lymphoid Malignancies (including non-Hodgkin Lymphoma, Hodgkin Lymphoma and Chronic Lymphocytic Leukemia) meeting the following criteria:
Age > 1 years, < 65yrs
KPS Performance status ≥80
Patients without a matched related or unrelated donor
Patient with either one or both:
Concurrent Therapy for Extramedullary Leukemia or central nervous system (CNS) Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia, and CNS lymphoma including standard intrathecal chemotherapy and/or radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Subjects must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Patients with inadequate Organ Function as defined by:
Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with Reduced Intensity Conditioning (RIC) have the significant potential for teratogenic or abortifacient effects.
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
Presence of donor-specific antibodies against chosen graft source.
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| Name | Affiliation | Role |
|---|---|---|
| Leland Metheny, MD | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Thiotepa + Fludarabine + Melphalan | Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3. Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells. Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash. Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent. Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash. Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thiotepa + Fludarabine + Melphalan | Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3. Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells. Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash. Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent. Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash. Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Percentage of Patients With Disease Free Survival | Leukemia Free Survival (LFS) at 1 year is the percentage of patients alive and without evidence of hematologic malignancy at 1 year after transplant. | 1 participant was non evaluable for this measure | Posted | Number | percentage of paticipants | Up to 1 year after transplant |
|
Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
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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 | Thiotepa + Fludarabine + Melphalan | Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3. Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells. Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash. Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent. Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash. Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principle Investigator | University Hospitals, Case Comprehensive Cancer Center | 216-844-0139 | Leland.Metheny@uhhospitals.org |
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| 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 | Feb 21, 2023 | Jul 31, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2025 | May 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| D013852 | Thiotepa |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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|
|
| Thiotepa | Drug | Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent. Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash. |
|
|
| Fludarabine | Drug | Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA. Fludarabine may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash, and lower limb weakness. |
|
|
| Up to 1 year after transplant |
| Treatment Related Mortality | Treatment Related Mortality (TRM) at 1 year is the percentage of patients who expire from treatment related toxicity attributed to transplant up to 1 year after transplant. | Up to 1 year after transplant |
| Incidence of Acute GVHD | Acute graft versus host disease (aGVHD) 1 year cumulative incidence is the percentage of patients who experience any aGVHD up to 1 year after transplant. | Up to 1 year after transplant |
| Incidence of Chronic GVHD | Chronic graft versus host disease (cGVHD) 1-year cumulative incidence is the percentage of patients who experience any cGVHD up to 1 year after transplant. | Up to 1 year after transplant |
| Rate of Neutrophil Engraftment | Neutrophil engraftment will be calculated as the days from transplant where the absolute neutrophil count (ANC) reaches >500cells/ul x 3 days. | Up to 1 year after transplant |
| Rate of Platelet Engraftment | Platelet engraftment will be calculated as the days from transplant where the platelet count reaches 20,000 platelets /ul without the need of transfusion of platelets for 7 days. | Up to 1 year after transplant |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Patients With Leukemia Free Survival | Trial changes eligibility amended to include other hematological diseases - of the 40 pts on study - 39 went to treatment, 1 on treatment non evaluable, and only 29 had Leukemia (ALL/CML/CMML and AML) | Posted | Number | percentage of paticipants | Up to 1 year after transplant |
|
|
|
| Secondary | Average Overall Survival | Overall Survival (OS) at 1 year is the percentage of patients alive at 1 year after transplant. | 1 participant was non evaluable for this measure | Posted | Number | percentage of participants | Up to 1 year after transplant |
|
|
|
| Secondary | Relapse Incidence | Relapse incidence at 1 year is the percentage of patients who experience relapse of their hematologic malignancy up to 1 year after transplant. | 9 participants were non evaluable for this measure | Posted | Number | percentage of participants | Up to 1 year after transplant |
|
|
|
| Secondary | Treatment Related Mortality | Treatment Related Mortality (TRM) at 1 year is the percentage of patients who expire from treatment related toxicity attributed to transplant up to 1 year after transplant. | 1 participant was non evaluable for this measure | Posted | Number | percentage of paticipants | Up to 1 year after transplant |
|
|
|
| Secondary | Incidence of Acute GVHD | Acute graft versus host disease (aGVHD) 1 year cumulative incidence is the percentage of patients who experience any aGVHD up to 1 year after transplant. | 1 participant was non evaluable for this measure | Posted | Number | percentage of participants | Up to 1 year after transplant |
|
|
|
| Secondary | Incidence of Chronic GVHD | Chronic graft versus host disease (cGVHD) 1-year cumulative incidence is the percentage of patients who experience any cGVHD up to 1 year after transplant. | 1 participant was non evaluable for this measure | Posted | Number | percentage of participants | Up to 1 year after transplant |
|
|
|
| Secondary | Rate of Neutrophil Engraftment | Neutrophil engraftment will be calculated as the days from transplant where the absolute neutrophil count (ANC) reaches >500cells/ul x 3 days. | 4 participants were non evaluable for this measure | Posted | Mean | Standard Deviation | Days | Up to 1 year after transplant |
|
|
|
| Secondary | Rate of Platelet Engraftment | Platelet engraftment will be calculated as the days from transplant where the platelet count reaches 20,000 platelets /ul without the need of transfusion of platelets for 7 days. | 5 participants were non evaluable for this measure | Posted | Mean | Standard Deviation | Days | Up to 1 year after transplant |
|
|
|
| 14 |
| 40 |
| 18 |
| 40 |
| 35 |
| 40 |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE v5.0 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE v5.0 | Systematic Assessment |
|
| Encephalitis infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Immune system disorders - Other, specify | Immune system disorders | CTCAE v5.0 | Systematic Assessment | GVHD |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE v5.0 | Systematic Assessment | Adenovirus Colitis |
|
| Enterocolitis infectious | Infections and infestations | CTCAE v5.0 | Systematic Assessment | D. difficile infection - IV antibiotic |
|
| Enterocolitis infectious | Infections and infestations | CTCAE v5.0 | Systematic Assessment | Yersinia Entercolitica Infection |
|
| Fungemia | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE v5.0 | Systematic Assessment | Stenotrophomonas Maltophilia |
|
| Lung infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | CTCAE v5.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE v5.0 | Systematic Assessment | Epilepsy associated infection, currently inconclusive on what infection caused the status epilepticus. |
|
| Sepsis | Infections and infestations | CTCAE v5.0 | Systematic Assessment | Septic shock due to Stenotrophomonas maltophilia. |
|
| Sinusoidal obstruction syndrome | Hepatobiliary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | CTCAE V5.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE V5.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE V5.0 | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Anorectal infection | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE V5.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE V5.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | Systematic Assessment |
|
| Bacteremia | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | CTCAE V5.0 | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE V5.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE V5.0 | Systematic Assessment |
|
| Chills | General disorders | CTCAE V5.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE V5.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE V5.0 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE V5.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | CTCAE V5.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Dysphagia | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE V5.0 | Systematic Assessment |
|
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE V5.0 | Systematic Assessment |
|
| Encephalitis infection | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Eye infection | Eye disorders | CTCAE V5.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE V5.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Fever | General disorders | CTCAE V5.0 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE V5.0 | Systematic Assessment |
|
| Fungemia | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Generalized edema | General disorders | CTCAE V5.0 | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | CTCAE V5.0 | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE V5.0 | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE V5.0 | Systematic Assessment |
|
| Hemolysis | Blood and lymphatic system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Herpes simplex reactivation | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE V5.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE V5.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE V5.0 | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE V5.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE V5.0 | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE V5.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE V5.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Immune system disorders - Other, specify | Immune system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Investigations - Other, specify | Investigations | CTCAE V5.0 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE V5.0 | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | CTCAE V5.0 | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | Systematic Assessment |
|
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE V5.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE V5.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Pain | General disorders | CTCAE V5.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE V5.0 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | CTCAE V5.0 | Systematic Assessment |
|
| Perineal pain | Reproductive system and breast disorders | CTCAE V5.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE V5.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE V5.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE V5.0 | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Serum amylase increased | Investigations | CTCAE V5.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE V5.0 | Systematic Assessment |
|
| Sinusoidal obstruction syndrome | Hepatobiliary disorders | CTCAE V5.0 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE V5.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Sudden death NOS | General disorders | CTCAE V5.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE V5.0 | Systematic Assessment |
|
| Thrush | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE V5.0 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE V5.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Viremia | Infections and infestations | CTCAE V5.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE V5.0 | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE V5.0 | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE V5.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |