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A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02979522
Recruitment Status : Active, not recruiting
First Posted : December 1, 2016
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Tracking Information
First Submitted Date  ICMJE November 11, 2016
First Posted Date  ICMJE December 1, 2016
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE September 6, 2017
Actual Primary Completion Date May 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • Phase 1: Determination of the Recommended Dose of Brentuximab Vedotin in Combination With doxorubicin, vinblastine, and dacarbazine in a Pediatric Population [ Time Frame: Up to 6 months ]
    The recommended dose of brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine for a pediatric population on the basis of the safety, tolerability, and preliminary pharmacokinetic (PK) and efficacy data (if available).
  • Phase 1: Percentage of Participants who Experience Adverse Events (AEs) From the First Dose of Protocol Therapy Through 30 days After Administration of the Last Dose of Protocol Therapy [ Time Frame: Up to 7 months ]
    The percentage of participants in the safety population who experience treatment emergent adverse events (TEAEs) for up to 6 months of treatment plus 30 days following the end of study treatment.
  • Phase 1: Percentage of Participants who Experience Serious Adverse Events (SAEs) From the First Dose of Protocol Therapy Through 30 days After Administration of the Last Dose of Protocol Therapy [ Time Frame: Up to 7 months ]
    The percentage of participants in the safety population who experience treatment-emergent SAEs for up to 6 months of treatment plus 30 days following the end of study treatment.
  • Phase 2: Percentage of Participants who Achieve a Complete Remission (CR) per Independent Review Facility (IRF) Assessment at end of treatment (EOT) per International Working Group (IWG) Criteria [ Time Frame: Up to 7 months ]
    Percentage of participants in the response-evaluable population who achieve a complete response based on the IRF assessment at the EOT visit based on the international working group (IWG) criteria.
  • Phase 2: Percentage of Participants Whose Disease is Positron Emission Tomography (PET) Negative After 2 Cycles of Protocol Therapy per IRF Assessment [ Time Frame: Up to 2 months ]
    Percentage of participants in the response-evaluable population whose disease is negative per PET after 2 cycles of protocol therapy per IRF assessment.
  • Phase 2: Percentage of Participants who Achieve a Partial Remission (PR) per IRF Assessment at EOT per IWG Criteria [ Time Frame: Up to 7 months ]
    Percentage of participants in the response-evaluable population who achieve a partial response based on the IRF assessment at the EOT visit based on the IWG criteria.
  • Phase 2: Percentage of Participants who Achieve an Overall Response (OR) per IRF Assessment at EOT per IWG Criteria [ Time Frame: Up to 7 months ]
    Percentage of participants in the response evaluable population who achieve an overall response based on the IRF assessment at the EOT visit based on the IWG criteria.
  • Phase 2: Percentage of Participants who are able to Complete 6 Cycles of Protocol Therapy at the Recommended Dose [ Time Frame: Up to 6 months ]
    Percentage of participants in the response-evaluable population who are able to complete six 28-day cycles of treatment at the recommended dose.
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
  • Phase 1: Determination of the Recommended Dose of Brentuximab Vedotin in Combination With doxorubicin, vinblastine, and dacarbazine in a Pediatric Population [ Time Frame: Up to 6 months ]
    The recommended dose of brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine for a pediatric population on the basis of the safety, tolerability, and preliminary pharmacokinetic (PK) and efficacy data (if available).
  • Phase 1: Percentage of Participants who Experience Adverse Events (AEs) From the First Dose of Protocol Therapy Through 30 days After Administration of the Last Dose of Protocol Therapy [ Time Frame: Up to 7 months ]
    The percentage of participants in the safety population who experience treatment emergent adverse events (TEAEs) for up to 6 months of treatment plus 30 days following the end of study treatment.
  • Phase 1: Percentage of Participants who Experience Serious Adverse Events (SAEs) From the First Dose of Protocol Therapy Through 30 days After Administration of the Last Dose of Protocol Therapy [ Time Frame: Up to 7 months ]
    The percentage of participants in the safety population who experience treatment-emergent SAEs for up to 6 months of treatment plus 30 days following the end of study treatment.
  • Phase 2: Percentage of Participants who Achieve a Complete Remission (CR) per Independent Review Facility (IRF) Assessment at end of treatment (EOT) per International Working Group (IWG) Criteria [ Time Frame: Up to 6 months ]
    Percentage of participants in the response-evaluable population who achieve a complete response based on the IRF assessment at the EOT visit based on the international working group (IWG) criteria.
  • Phase 2: Percentage of Participants Whose Disease is Positron Emission Tomography (PET) Negative After 2 Cycles of Protocol Therapy per IRF Assessment [ Time Frame: Up to 2 months ]
    Percentage of participants in the response-evaluable population whose disease is negative per PET after 2 cycles of protocol therapy per IRF assessment.
  • Phase 2: Percentage of Participants who Achieve a Partial Remission (PR) per IRF Assessment at EOT per IWG Criteria [ Time Frame: Up to 6 months ]
    Percentage of participants in the response-evaluable population who achieve a partial response based on the IRF assessment at the EOT visit based on the IWG criteria.
  • Phase 2: Percentage of Participants who Achieve an Overall Response (OR) per IRF Assessment at EOT per IWG Criteria [ Time Frame: Up to 6 months ]
    Percentage of participants in the response evaluable population who achieve an overall response based on the IRF assessment at the EOT visit based on the IWG criteria.
  • Phase 2: Percentage of Participants who are able to Complete 6 Cycles of Protocol Therapy at the Recommended Dose [ Time Frame: Up to 6 months ]
    Percentage of participants in the response-evaluable population who are able to complete six 28-day cycles of treatment at the recommended dose.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • Phase 1: Mean Maximum Observed Plasma Concentration (Cmax) of Brentuximab Vedotin (Serum), Total (free and conjugated) Therapeutic Antibody (TAb) (Serum), and Monomethyl Auristatin E (MMAE) (Plasma) [ Time Frame: Up to 15 days ]
    Mean maximum concentration from Day 0 to Day 15 for brentuximab vedotin and TAb in serum and MMAE in plasma based on data from the PK population.
  • Phase 1: Mean Area Under the Plasma Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) [ Time Frame: Up to 15 days ]
    Mean AUC from Day 0 to Day 15 for brentuximab vedotin and TAb in serum and MMAE in plasma based on data from the PK population.
  • Phase 1: Median Time to Reach Cmax (Tmax) of Brentuximab Vedotin (serum), TAb (serum), and MMAE (plasma) [ Time Frame: Up to 15 days ]
    First time of occurrence of maximum (peak) concentration for a single dose of brentuximab vedotin for participants in the PK population.
  • Phase 1: Percentage of Participants who Achieve a CR per IRF Assessment at EOT per IWG Criteria [ Time Frame: Up to 7 months ]
    Percentage of participants in the response-evaluable population who achieve a complete response based on the IRF assessment at the EOT visit based on the IWG criteria.
  • Phase 1: Percentage of Participants who Achieve a PR per IRF Assessment at EOT per IWG Criteria [ Time Frame: Up to 7 months ]
    Percentage of participants in the response-evaluable population who achieve a partial response based on the IRF assessment at the EOT visit based on the IWG criteria.
  • Phase 1: Percentage of Participants who Achieve an OR per IRF Assessment at EOT per IWG Criteria [ Time Frame: Up to 7 months ]
    Percentage of participants in the response-evaluable population who achieve an overall response based on the IRF assessment at the EOT visit based on the IWG criteria.
  • Phase 1: Percentage of Participants Whose Disease is PET Negative after 2 Cycles of Protocol Therapy per IRF Assessment [ Time Frame: Up to 2 months ]
    Percentage of participants in the response evaluable population whose disease is negative per PET after 2 cycles of protocol therapy per IRF assessment.
  • Phase 1: Percentage of Participants Whose Disease is PET Positive After 6 Cycles of Protocol Therapy per IRF Assessment [ Time Frame: Up to 6 months ]
    Percentage of participants in the response-evaluable population whose disease is positive per PET after 6 cycles of protocol therapy per IRF assessment.
  • Phase 1: Percentage of Participants who are Antitherapeutic Antibody (ATA) Positive, Persistently Positive or Transiently Positive, and Neutralizing Antitherapeutic Antibody (nATA) Positive [ Time Frame: Up to 7 months ]
    Percentage of participants in the safety population who are ATA positive, persistently positive, or transiently positive, and nATA positive.
  • Phase 2: Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]
  • Phase 2: Event-free Survival (EFS) [ Time Frame: Up to 24 months ]
  • Phase 2: Overall Survival (OS) [ Time Frame: Up to 24 months ]
  • Phase 2: Duration of Response (DOR) [ Time Frame: Up to 24 months ]
  • Phase 2: Percentage of Participants Receiving Irradiation for HL Following Study Treatment [ Time Frame: Up to 24 months ]
    Percentage of participants receiving irradiation for HL after up to 6 months of study treatment.
  • Phase 2: Percentage of Participants who Experience AEs From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy [ Time Frame: Up to 7 months ]
    The percentage of participants in the safety population who experience TEAEs for up to 6 months of treatment plus 30 days following the end of study treatment.
  • Phase 2: Percentage of Participants who Experience SAEs From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy [ Time Frame: Up to 7 months ]
    The percentage of participants in the safety population who experience treatment-emergent SAEs for up to 6 months of treatment plus 30 days following the end of study treatment.
  • Phase 2: Percentage of Participants who are ATA Positive, Persistently Positive, or Transiently Positive, and nATA Positive [ Time Frame: Up to 7 months ]
    Percentage of participants in the safety population who are ATA positive, persistently positive, or transiently positive, and nATA positive.
  • Phase 2: Mean Cmax of Brentuximab Vedotin (Serum), TAb (Serum), and MMAE (Plasma) [ Time Frame: Up to 15 days ]
    Mean maximum concentration from Day 0 to Day 15 for brentuximab vedotin and TAb in serum and MMAE in plasma based on data from the PK population.
  • Phase 2: Mean AUC0-15 of Brentuximab Vedotin (Serum), TAb (Serum), and MMAE (Plasma) [ Time Frame: Up to 15 days ]
    Mean AUC from Day 0 to Day 15 for brentuximab vedotin and TAb in serum and MMAE in plasma based on data from the PK population.
  • Phase 2: Median Tmax of Brentuximab Vedotin (Serum), TAb (Serum), and MMAE (Plasma) [ Time Frame: Up to 15 days ]
    First time of occurrence of maximum (peak) concentration for a single dose of brentuximab vedotin for participants in the PK population.
  • Phase 2: Percentage of Participants who Experience Peripheral Neuropathy, Regardless of Seriousness, From the First Dose of Protocol Therapy Through Study Closure [ Time Frame: Up to 24 months ]
    Percentage of participants who experience peripheral neuropathy, regardless of seriousness, from the first dose of protocol therapy through study closure.
  • Phase 2: Time to Onset and Time to Resolution for all Peripheral Neuropathy Events [ Time Frame: Up to 24 months ]
    Time from first dose of protocol therapy to onset, and time from onset to resolution for all peripheral neuropathy events.
  • Phase 2: Immune Reconstitution Over Time [ Time Frame: Up to 24 months ]
    Immune reconstitution (peripheral blood CD34+ count; enumeration of the total lymphocyte count and lymphocyte subsets; total immunoglobulin and Immunoglobulin (Ig) G, IgM, IgA levels; levels of antibodies to tetanus, hemophilus influenza type B (HiB), and polio serotypes).
  • Phase 1: ATA Titer [ Time Frame: Up to 6 months ]
  • Phase 2: ATA Titer [ Time Frame: Up to 6 months ]
  • Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 1: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 1: Percentage of Participants Achieving CR per IRF Assessment per IWG Criteria in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 1: Incidence and Severity of AEs and SAEs in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 2: Percentage of Participants Achieving CR per IRF Assessment per IWG Criteria in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 2: Incidence and Severity of AEs and SAEs in ATA Positive and ATA Negative participants [ Time Frame: Up to 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
  • Phase 1: Mean Maximum Observed Plasma Concentration (Cmax) of Brentuximab Vedotin (Serum), Total (free and conjugated) Therapeutic Antibody (TAb) (Serum), and Monomethyl Auristatin E (MMAE) (Plasma) [ Time Frame: Up to 15 days ]
    Mean maximum concentration from Day 0 to Day 15 for brentuximab vedotin and TAb in serum and MMAE in plasma based on data from the PK population.
  • Phase 1: Mean Area Under the Plasma Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) [ Time Frame: Up to 15 days ]
    Mean AUC from Day 0 to Day 15 for brentuximab vedotin and TAb in serum and MMAE in plasma based on data from the PK population.
  • Phase 1: Median Time to Reach Cmax (Tmax) of Brentuximab Vedotin (serum), TAb (serum), and MMAE (plasma) [ Time Frame: Up to 15 days ]
    First time of occurrence of maximum (peak) concentration for a single dose of brentuximab vedotin for participants in the PK population.
  • Phase 1: Percentage of Participants who Achieve a CR per IRF Assessment at EOT per IWG Criteria [ Time Frame: Up to 6 months ]
    Percentage of participants in the response-evaluable population who achieve a complete response based on the IRF assessment at the EOT visit based on the IWG criteria.
  • Phase 1: Percentage of Participants who Achieve a PR per IRF Assessment at EOT per IWG Criteria [ Time Frame: Up to 6 months ]
    Percentage of participants in the response-evaluable population who achieve a partial response based on the IRF assessment at the EOT visit based on the IWG criteria.
  • Phase 1: Percentage of Participants who Achieve an OR per IRF Assessment at EOT per IWG Criteria [ Time Frame: Up to 6 months ]
    Percentage of participants in the response-evaluable population who achieve an overall response based on the IRF assessment at the EOT visit based on the IWG criteria.
  • Phase 1: Percentage of Participants Whose Disease is PET Negative after 2 Cycles of Protocol Therapy per IRF Assessment [ Time Frame: Up to 2 months ]
    Percentage of participants in the response evaluable population whose disease is negative per PET after 2 cycles of protocol therapy per IRF assessment.
  • Phase 1: Percentage of Participants Whose Disease is PET Positive After 6 Cycles of Protocol Therapy per IRF Assessment [ Time Frame: Up to 6 months ]
    Percentage of participants in the response-evaluable population whose disease is positive per PET after 6 cycles of protocol therapy per IRF assessment.
  • Phase 1: Percentage of Participants who are Antitherapeutic Antibody (ATA) Positive, Persistently Positive or Transiently Positive, and Neutralizing Antitherapeutic Antibody (nATA) Positive [ Time Frame: Up to 6 months ]
    Percentage of participants in the safety population who are ATA positive, persistently positive, or transiently positive, and nATA positive.
  • Phase 2: Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]
  • Phase 2: Event-free Survival (EFS) [ Time Frame: Up to 24 months ]
  • Phase 2: Overall Survival (OS) [ Time Frame: Up to 24 months ]
  • Phase 2: Duration of Response (DOR) [ Time Frame: Up to 24 months ]
  • Phase 2: Percentage of Participants Receiving Irradiation for HL Following Study Treatment [ Time Frame: Up to 24 months ]
    Percentage of participants receiving irradiation for HL after up to 6 months of study treatment.
  • Phase 2: Percentage of Participants who Experience AEs From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy [ Time Frame: Up to 7 months ]
    The percentage of participants in the safety population who experience TEAEs for up to 6 months of treatment plus 30 days following the end of study treatment.
  • Phase 2: Percentage of Participants who Experience SAEs From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy [ Time Frame: Up to 7 months ]
    The percentage of participants in the safety population who experience treatment-emergent SAEs for up to 6 months of treatment plus 30 days following the end of study treatment.
  • Phase 2: Percentage of Participants who are ATA Positive, Persistently Positive, or Transiently Positive, and nATA Positive [ Time Frame: Up to 6 months ]
    Percentage of participants in the safety population who are ATA positive, persistently positive, or transiently positive, and nATA positive.
  • Phase 2: Mean Cmax of Brentuximab Vedotin (Serum), TAb (Serum), and MMAE (Plasma) [ Time Frame: Up to 15 days ]
    Mean maximum concentration from Day 0 to Day 15 for brentuximab vedotin and TAb in serum and MMAE in plasma based on data from the PK population.
  • Phase 2: Mean AUC0-15 of Brentuximab Vedotin (Serum), TAb (Serum), and MMAE (Plasma) [ Time Frame: Up to 15 days ]
    Mean AUC from Day 0 to Day 15 for brentuximab vedotin and TAb in serum and MMAE in plasma based on data from the PK population.
  • Phase 2: Median Tmax of Brentuximab Vedotin (Serum), TAb (Serum), and MMAE (Plasma) [ Time Frame: Up to 15 days ]
    First time of occurrence of maximum (peak) concentration for a single dose of brentuximab vedotin for participants in the PK population.
  • Phase 2: Percentage of Participants who Experience Peripheral Neuropathy, Regardless of Seriousness, From the First Dose of Protocol Therapy Through Study Closure [ Time Frame: Up to 7 months ]
    Percentage of participants who experience peripheral neuropathy, regardless of seriousness, from the first dose of protocol therapy through study closure.
  • Phase 2: Time to Onset and Time to Resolution for all Peripheral Neuropathy Events [ Time Frame: Up to 24 months ]
    Time from first dose of protocol therapy to onset, and time from onset to resolution for all peripheral neuropathy events.
  • Phase 2: Immune Reconstitution Over Time [ Time Frame: Up to 24 months ]
    Immune reconstitution (peripheral blood CD34+ count; enumeration of the total lymphocyte count and lymphocyte subsets; total immunoglobulin and Immunoglobulin (Ig) G, IgM, IgA levels; levels of antibodies to tetanus, hemophilus influenza type B (HiB), and polio serotypes).
  • Phase 1: ATA Titer [ Time Frame: Up to 6 months ]
  • Phase 2: ATA Titer [ Time Frame: Up to 6 months ]
  • Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 1: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 1: Percentage of Participants Achieving CR per IRF Assessment per IWG Criteria in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 1: Incidence and Severity of AEs and SAEs in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 2: Percentage of Participants Achieving CR per IRF Assessment per IWG Criteria in ATA Positive and ATA Negative Participants [ Time Frame: Up to 24 months ]
  • Phase 2: Incidence and Severity of AEs and SAEs in ATA Positive and ATA Negative participants [ Time Frame: Up to 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
Official Title  ICMJE An Open-Label Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
Brief Summary The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric participants with advanced stage newly diagnosed classical CD30+ Hodgkin Lymphoma (HL).
Detailed Description

The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat pediatric participants who have advanced stage, newly diagnosed, classical CD30+ HL. This study will assess the safety, tolerability, and anti-tumor activity, as well as recommended dose of brentuximab vedotin in combination with a multiagent chemotherapy regimen that is based on a current standard of care (SOC) first-line treatment regimen for newly diagnosed HL.

The study will enroll approximately 59 evaluable participants. The study will be conducted in 2 phases, Phase 1 and Phase 2. Phase 1 study will enroll up to 12 participants to determine the recommended dose. Once the recommended dose is identified additional participants will be enrolled into phase 2 so that the total number of evaluable participants will be approximately 59, including participants treated at recommended dose in Phase 1. Participants will be enrolled in the following 2 dose Cohorts:

• Brentuximab vedotin 48 mg/m^2 or 36 mg/m^2 in combination with doxorubicin, vinblastine, and dacarbazine.

Phase 1 has completed enrollment and Phase 2 is now open for enrollment.

This multi-center trial will be conducted in United States (US), Italy, Brazil, Japan. The overall time to participate in this study is approximately 55 months, including the follow-up period. Participants will be followed for a maximum of 30 days following the last dose of protocol therapy for a follow-up assessment and will be followed for survival until death or study closure, or up to 2 years after enrollment of the last participant. All participants will have an opportunity to participate in an optional long-term follow up, for at least 10 years after participant enrollment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin Disease
Intervention  ICMJE
  • Drug: Brentuximab vedotin
    Brentuximab vedotin infusion
    Other Name: Adcetris
  • Drug: Doxorubicin
    Doxorubicin infusion
    Other Name: Adriamycin
  • Drug: Vinblastine
    Vinblastine infusion
  • Drug: Dacarbazine
    Dacarbazine infusion
Study Arms  ICMJE Experimental: Brentuximab vedotin 48 mg/m^2
Brentuximab vedotin 48 milligram per square meter (mg/m^2), intravenous infusion, once on Day 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and Dacarbazine 375 mg/m^2, intravenous infusion, once on Day 1 and 15 of each 28-day cycle for up to 6 cycles. If the first 6 participants complete the dose limiting toxicity (DLT) observation period with 0 or 1 participant experiencing a DLT, 48 mg/m^2 will be established as the recommended dose for phase 2 study. If at any time more than 1 participant out of a maximum 6 DLT-evaluable participants experiences a DLT, brentuximab vedotin dose will be reduced to 36 mg/m^2. If 0 or 1 participant experiences a DLT among the 6 participants treated at 36 mg/m^2, 36 mg/m^2 will be established as recommended dose for phase 2 study. If more than 1 participant experiences a DLT in the first 6 participants treated at 36 mg/m^2, the study will be discontinued.
Interventions:
  • Drug: Brentuximab vedotin
  • Drug: Doxorubicin
  • Drug: Vinblastine
  • Drug: Dacarbazine
Publications * Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. J Clin Pharmacol. 2020 Jun 28. doi: 10.1002/jcph.1682. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 25, 2019)
59
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2016)
55
Estimated Study Completion Date  ICMJE September 24, 2021
Actual Primary Completion Date May 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Each participant must meet all the following inclusion criteria to be enrolled in the study:

  1. Histologically confirmed CD30+ classical HL.
  2. Advanced stage, newly diagnosed HL (Stage III and Stage IV disease).
  3. Treatment-naive HL.
  4. Have performance scores of greater than or equal to (>=) 50 for Lansky Play-performance or Karnofsky Performance Status.

Exclusion Criteria:

  1. Nodular lymphocyte predominant HL.
  2. Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML.
  3. Any sensory or motor peripheral neuropathy.
  4. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Hong Kong,   Italy,   Japan,   Singapore,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02979522
Other Study ID Numbers  ICMJE C25004
2015-004112-38 ( EudraCT Number )
U1111-1171-0984 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Responsible Party Takeda ( Millennium Pharmaceuticals, Inc. )
Study Sponsor  ICMJE Millennium Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Clinical Science Millennium Pharmaceuticals, Inc.
PRS Account Takeda
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP