Clinical Trials /

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

NCT02979522

Description:

The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as confirm the 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).

Related Conditions:
  • Hodgkin Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
  • Official Title: An Open-Label Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: C25004
  • SECONDARY ID: 2015-004112-38
  • SECONDARY ID: U1111-1171-0984
  • NCT ID: NCT02979522

Conditions

  • Hodgkin Disease

Interventions

DrugSynonymsArms
Brentuximab vedotinAdcetrisBrentuximab vedotin 48 mg/m^2
DoxorubicinAdriamycinBrentuximab vedotin 48 mg/m^2
VinblastineBrentuximab vedotin 48 mg/m^2
DacarbazineBrentuximab vedotin 48 mg/m^2

Purpose

The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as confirm the 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.

      Participants continue in follow-up to Sept 2021 and may continue in the optional long-term
      follow-up to Sept 2029.

      This multi-center trial will be conducted in the United States, Italy, Brazil and 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.
    

Trial Arms

NameTypeDescriptionInterventions
Brentuximab vedotin 48 mg/m^2ExperimentalBrentuximab 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.
  • Brentuximab vedotin
  • Doxorubicin
  • Vinblastine
  • Dacarbazine

Eligibility Criteria

        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.

          5. Have bidimensional measurable disease as documented by radiographic technique per
             International Working Group (IWG) criteria.

          6. Have adequate blood counts, renal and liver function as defined in the protocol.

        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.

          5. Any active systemic viral, bacterial, or fungal infection requiring systemic
             antibiotics within 2 weeks before the first study protocol therapy.

          6. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient
             contained in the drug formulation of brentuximab vedotin or any component of AVD.

          7. Known human immunodeficiency virus positive.

          8. Known hepatitis B surface antigen positive or known or suspected active hepatitis C
             infection, as determined by hepatitis B DNA or hepatitis C RNA, respectively, in
             blood.

          9. Diagnosed or treated for another malignancy within 3 years before the first dose or
             previously diagnosed with another malignancy and have any evidence of residual
             disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type
             are not excluded if they have undergone complete resection.

         10. Use of any strong or listed moderate cytochrome P450 (CYP) 3A4 inhibitors less than
             (<) 2 weeks before the first dose of protocol therapy (please refer to the Study
             Manual for an example list of prohibited CYP3A4 inhibitors).

         11. Any of the following cardiovascular conditions or values within 6 months before the
             first dose of protocol therapy:

               -  Shortening fraction of <27 percent (%) by echocardiogram or, if echocardiogram
                  not feasible, ejection fraction of <50% by radionuclide angiogram (RNA or MUGA
                  [multiple-gated acquisition scan]).

               -  New York Heart Association Class III or IV heart failure.

               -  Evidence of current uncontrolled cardiovascular conditions, including cardiac
                  arrhythmias, congestive heart failure, angina, or electrocardiographic evidence
                  of acute ischemia or active conduction system abnormalities.
      
Maximum Eligible Age:17 Years
Minimum Eligible Age:5 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1: Recommended Dose of Brentuximab Vedotin in Combination With Doxorubicin, Vinblastine, and Dacarbazine in a Pediatric Population
Time Frame:From the first dose (Cycle 1) up to Day 56 (Cycle length=28 days)
Safety Issue:
Description:The recommended dose was determined after considering all safety data in phase 1 and assessing for dose limiting toxicities (DLTs) which are defined as the dose range at which less than or equal to (<=) 1 of 6 evaluable participants experience DLT within the defined observation period (Cycle 1 + 28 days). This outcome measure is planned to be assessed only for participants treated in Phase 1 arm.

Secondary Outcome Measures

Measure:Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin and Total (Free and Conjugated) Therapeutic Antibody (TAb)
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Mean Maximum Observed Plasma Concentration (Cmax) of Monomethyl Auristatin E (MMAE)
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Mean Area Under the Plasma Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of MMAE
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Median Time to Reach Cmax (Tmax) of Brentuximab Vedotin and TAb in Serum
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Median Time to Reach Cmax (Tmax) of MMAE in Plasma
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Percentage of Participants Who Achieved a CR Per IRF Assessment Per IWG Criteria at EOT Visit
Time Frame:At EOT visit 30 days after the last dose of study drug (at Month 7)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Percentage of Participants Who Achieved a PR Per IRF Assessment Per IWG Criteria at EOT Visit
Time Frame:At EOT visit 30 days after the last dose of study drug (at Month 7)
Safety Issue:
Description:PR was defined as regression of measurable disease and no new diseases as per IWG Criteria based on IRF. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Percentage of Participants Who Achieved an OR Per IRF Assessment Per IWG Criteria at EOT Visit
Time Frame:At EOT visit 30 days after the last dose of study drug (at Month 7)
Safety Issue:
Description:Overall response rate was defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria. CR was defined as the disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Percentage of Participants Whose Disease Was PET Negative After 2 Cycles of Protocol Therapy Per IRF Assessment
Time Frame:From first dose of study drug up to Cycle 2 (Each Cycle length=28 days)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Percentage of Participants Whose Disease Was PET Positive After 6 Cycles of Protocol Therapy Per IRF Assessment
Time Frame:From first dose of study drug up to Cycle 6 (Each Cycle length=28 days)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Percentage of Participants Who Were Antitherapeutic Antibody (ATA) Positive, Persistently Positive or Transiently Positive, and Neutralizing Antitherapeutic Antibody (nATA) Positive
Time Frame:Up to 7 months
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Progression-free Survival (PFS)
Time Frame:Up to 24 months
Safety Issue:
Description:PFS per IRF: time from first dose until disease progression per IRF/death due to any cause, whichever occurred first. Participants who did not have objective progressive disease (PD), did not die, were either still on study follow-up at time of analysis were removed from study prior to documentation of PD, PFS were censored on date of last adequate disease assessment before initiation of any non-protocol, alternative therapy. Participants who were on antitumor treatment, other than SCT, or radiotherapy, censoring was at last adequate disease assessment before initiation of such alternative treatment. If participant experienced disease progression per IRF/died after initiation of antitumor treatment, other than SCT, or radiotherapy, such participant were censored and not considered having PFS. Outcome measure is planned to be assessed for all participant treated at RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (September 2021).
Measure:Phase 2: Event-free Survival (EFS)
Time Frame:Up to 24 months
Safety Issue:
Description:EFS:Time from the first dose until any treatment failure:PD per IRF including progression events during follow-up period, failing to complete 6 cycles of treatment due to any reason or death due to any cause, whichever occurred first. EFS per IRF were censored on the last adequate disease assessment date per IRF if none of the above events occur during the study.For participants who were given antitumor treatment, other than SCT, or radiotherapy as part of frontline treatment, censoring was done at the last adequate disease assessment before initiation of such alternative treatment.If a participant experienced disease progression per IRF/died after the initiation of antitumor treatment, other than SCT, or radiotherapy, such participant was censored, and not be considered having EFS.This outcome measure is planned to be assessed for all patients treated at the RP2D in Phase 2.Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Overall Survival (OS)
Time Frame:Up to 24 months
Safety Issue:
Description:Overall survival was defined as time from first dose until death. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive, including study closure. This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Duration of Response (DOR)
Time Frame:Up to 24 months
Safety Issue:
Description:DOR per IRF in participants with a response (CR or PR per IRF) was defined as the time from start of the first objective tumor response (CR or PR per IRF) to the first subsequent PD or death due to any cause, whichever occurred first. For patients who did not have an objective PD, did not die and are either still on a study follow-up at the time of the analysis, or were removed from the study prior to documentation of PD, DOR has been censored on the date of last adequate disease assessment. This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Percentage of Participants Receiving Irradiation for HL Following Study Treatment
Time Frame:Up to 24 months
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Percentage of Participants Who Experienced AEs From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy
Time Frame:From first dose in Cycle 1 Day 1 until 30 days after the last dose of study drug in Cycle 6 Day 15 (up to Cycle 7 Day 15) (Cycle length=28 days)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Percentage of Participants Who Experienced SAEs From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy
Time Frame:From first dose in Cycle 1 Day 1 until 30 days after the last dose of study drug in Cycle 6 Day 15 (up to Cycle 7 Day 15) (Cycle length=28 days)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Percentage of Participants Who Were ATA Positive, Persistently Positive, or Transiently Positive, and nATA Positive
Time Frame:From first dose until 30 days after the last dose of study drug (up to 7 months)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Mean Serum Cmax of Brentuximab Vedotin and TAb
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Mean Plasma Cmax of MMAE
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Mean Serum AUC0-15 of Brentuximab Vedotin and TAb
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Mean Plasma AUC0-15 of MMAE
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Median Tmax of Brentuximab Vedotin and TAb in Serum
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Median Tmax of MMAE in Plasma
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Percentage of Participants Who Experienced Peripheral Neuropathy, Regardless of Seriousness, From the First Dose of Protocol Therapy
Time Frame:Up to 24 months
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Time to Onset and Resolution for All Peripheral Neuropathy Events
Time Frame:Up to 24 months
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Immune Reconstitution Over Time
Time Frame:Up to 24 months
Safety Issue:
Description: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). This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: ATA Titer
Time Frame:Up to 6 months
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: ATA Titer
Time Frame:Up to 6 months
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure: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
Safety Issue:
Description:CR was defined as the disappearance of all evidence of disease as assessed by IRF as per IWG Criteria. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 1: Number of ATA Positive and ATA Negative Participants With AEs and SAEs
Time Frame:Up to 24 months
Safety Issue:
Description:This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants
Time Frame:Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days)
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure: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
Safety Issue:
Description:CR is defined as the disappearance of all evidence of disease as assessed by IRF as per IWG Criteria. This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).
Measure:Phase 2: Number of ATA Positive and ATA Negative Participants With AEs and SAEs
Time Frame:Up to 24 months
Safety Issue:
Description:This outcome measure was planned to be assessed only for all participants treated at the RP2D in Phase 2. Data for this secondary outcome measure will be reported after study completion date (which is September 2021).

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Millennium Pharmaceuticals, Inc.

Trial Keywords

  • Drug therapy, pediatric Hodgkin disease, frontline Hodgkin disease, advanced stage Hodgkin disease, pediatric lymphoma

Last Updated

June 1, 2021