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Report for D006689: Hodgkin Disease NIH
(Synonyms: Hodgkin, Hodgkin, Hodgkin Di, Hodgkin Dise, Hodgkin Disease)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012189 | Hodgkin lymphoma HPO | 1.00 |
| HP:0002665 | Lymphoma HPO | 0.45 |
There is one clinical trial.
Clinical Trials
1 A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).
NCT04052997 Relapsed Hodgkin Lymphoma Refractory Hodgkin Lymphoma Drug: Camidanlumab Tesirine MeSH:Lymphoma Hodgkin Disease
HPO:Hodgkin lymphoma Lymphoma
Primary Outcomes
Description: ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).
Measure: Objective Response Rate (ORR) Time: Up to 3 years
Secondary Outcomes
Description: DOR defined as the time from the first documentation of tumor response to disease progression or death.
Measure: Duration of Response (DOR) Time: Up to 3 years
Description: CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.
Measure: Complete Response (CR) Rate Time: Up to 3 years
Description: Relapse-free survival (RFS) defined as the time from the documentation of CR to disease progression or death due to any case.
Measure: Relapse-Free Survival (RFS) Time: Up to 3 years
Description: PFS defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause.
Measure: Progression-Free Survival (PFS) Time: Up to 3 years
Description: OS defined as the time from first dose of study drug until death due to any cause.
Measure: Overall Survival (OS) Time: Up to 3 years
Measure: Fraction of Participants Who Receive Hematopoietic Stem Cell Transplant (HSCT) Time: Up to 3 years
Description: An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier.
Measure: Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE) Time: Day 1 (post-dose) until 30 days after last dose of study drug
Description: An SAE is defined as any adverse event (AE) that:
results in death.
is life threatening.
requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE).
results in persistent or significant disability/incapacity.
is a congenital anomaly/birth defect.
important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Measure: Number of Participants Who Experience At Least One Serious Adverse Event (SAE) Time: Day 1 (post-dose) until 30 days after last dose of study drug
Description: Parameters measured will include clinical hematology, coagulation panel, biochemistry, and urinalysis.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Description: Vital signs include the measurements of arterial blood pressure (systolic and diastolic), heart rate (HR), respiratory rate, and body temperature.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Description: The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECGs) Results Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Measure: Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Time to Reach Maximum Plasma Concentration (Tmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Clearance (CL) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Volume of Distribution (Vd) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Description: Measurement of Anti-drug antibodies to ADCT-301 before, during and after treatment with Camidanlumab Tesirine
Measure: Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Measure: Number of Participants With At Least One ADA Titer Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Measure: Number of Participants With Neutralizing Antibodies To Camidanlumab Tesirine Following Treatment With Camidanlumab Tesirine Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Description: The EQ-5D-5L is a tool for evaluating quality of life (QoL). The instrument consists of 2 parts: the descriptive system and the visual analog scale (VAS). The 1st part comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant evaluates each dimension by ticking the box next to the most appropriate level (1-5). This decision results in a 1-digit number that represents the level selected for that dimension. A high level indicates a negative rating. These digits are combined into a 5-digit number that describes the participant's health state. The 2nd part involves the participant indicating their health state on that day on a VAS (by placing an 'X'), where the endpoints are labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). A low score indicates a negative result.
Measure: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.
Description: The FACT-Lym is a lymphoma-specific subscale for the Functional Assessment of Cancer Therapy (FACT) questionnaire. The questionnaire consists of 15 specific items that are used together with the core 27-item questionnaire FACT-G. The participant is asked to give each item a score of between 0-4 (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much). A higher score indicates a worse level of QoL.
Measure: Change from Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.
HPO Nodes
Primary Outcomes
Description: ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).
Measure: Objective Response Rate (ORR) Time: Up to 3 yearsSecondary Outcomes
Description: DOR defined as the time from the first documentation of tumor response to disease progression or death.
Measure: Duration of Response (DOR) Time: Up to 3 yearsDescription: CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.
Measure: Complete Response (CR) Rate Time: Up to 3 yearsDescription: Relapse-free survival (RFS) defined as the time from the documentation of CR to disease progression or death due to any case.
Measure: Relapse-Free Survival (RFS) Time: Up to 3 yearsDescription: PFS defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause.
Measure: Progression-Free Survival (PFS) Time: Up to 3 yearsDescription: OS defined as the time from first dose of study drug until death due to any cause.
Measure: Overall Survival (OS) Time: Up to 3 yearsMeasure: Fraction of Participants Who Receive Hematopoietic Stem Cell Transplant (HSCT) Time: Up to 3 years
Description: An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation where participants are administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy/procedure, whichever comes earlier.
Measure: Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE) Time: Day 1 (post-dose) until 30 days after last dose of study drugDescription: An SAE is defined as any adverse event (AE) that: results in death. is life threatening. requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE). results in persistent or significant disability/incapacity. is a congenital anomaly/birth defect. important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Measure: Number of Participants Who Experience At Least One Serious Adverse Event (SAE) Time: Day 1 (post-dose) until 30 days after last dose of study drugDescription: Parameters measured will include clinical hematology, coagulation panel, biochemistry, and urinalysis.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)Description: Vital signs include the measurements of arterial blood pressure (systolic and diastolic), heart rate (HR), respiratory rate, and body temperature.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)Description: The ECOG Performance Status is a scale used to asses a person's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale consists of 6 grades, ranging from 0 to 5. A grade of 0 indicates the person is fully active and able to carry on as normal, and a grade of 5 indicates death.
Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)Measure: Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECGs) Results Time: Day 1 to end of treatment (maximum 30 days after last dose of study drug)
Measure: Maximum Observed Plasma Concentration (Cmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Time to Reach Maximum Plasma Concentration (Tmax) of Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Apparent Terminal Elimination Half-Life (T1/2) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Clearance (CL) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Volume of Distribution (Vd) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Measure: Accumulation Index (AI) For Camidanlumab Tesirine Total Antibody, PBD-Conjugated Antibody, and Unconjugated Warhead SG3199 Time: Cycle 1 and 2: Day 1 (pre-dose, EOI and post-dose), Day 8 and Day 15. Cycles 3 to 6: Day 1 (pre-dose and EOI). For remaining cycles: Day 1 (pre-dose) of each cycle until EOT, maximum of 30 days after the last dose of study drug. Each cycle is 21 days.
Description: Measurement of Anti-drug antibodies to ADCT-301 before, during and after treatment with Camidanlumab Tesirine
Measure: Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Responses Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drugMeasure: Number of Participants With At Least One ADA Titer Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Measure: Number of Participants With Neutralizing Antibodies To Camidanlumab Tesirine Following Treatment With Camidanlumab Tesirine Time: Day 1 until end of treatment, a maximum of 30 days after last dose of study drug
Description: The EQ-5D-5L is a tool for evaluating quality of life (QoL). The instrument consists of 2 parts: the descriptive system and the visual analog scale (VAS). The 1st part comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant evaluates each dimension by ticking the box next to the most appropriate level (1-5). This decision results in a 1-digit number that represents the level selected for that dimension. A high level indicates a negative rating. These digits are combined into a 5-digit number that describes the participant's health state. The 2nd part involves the participant indicating their health state on that day on a VAS (by placing an 'X'), where the endpoints are labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). A low score indicates a negative result.
Measure: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.Description: The FACT-Lym is a lymphoma-specific subscale for the Functional Assessment of Cancer Therapy (FACT) questionnaire. The questionnaire consists of 15 specific items that are used together with the core 27-item questionnaire FACT-G. The participant is asked to give each item a score of between 0-4 (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much). A higher score indicates a worse level of QoL.
Measure: Change from Baseline in HRQoL as Measured by Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Time: Day 1 of each 21 day cycle until end of treatment, a maximum of up to 30 days after last dose of study drug. Each cycle is 21 days.