Clinical Trials in Italy / NCT02979522
Active, not recruiting
Phase 1/2
A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
NCT02979522 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Hodgkin Disease
Investigational drug(s) / intervention(s)
Brentuximab vedotin: Brentuximab vedotin infusion
Doxorubicin: Doxorubicin infusion
Vinblastine: Vinblastine infusion
Dacarbazine: Dacarbazine infusion
Study summary
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).
Eligibility
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.
Primary outcome measure(s)
- Phase 1: Recommended Dose of Brentuximab Vedotin in Combination With Doxorubicin, Vinblastine, and Dacarbazine in a Pediatric Population — From the first dose (Cycle 1) up to Day 56 (Cycle length=28 days)
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. - Phase 1: Percentage of Participants Who Experienced Adverse Events (AEs) From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy — 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)
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. - Phase 1: Percentage of Participants Who Experienced Serious Adverse Events (SAEs) From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy — 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)
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, Is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, Is a congenital anomaly/birth defect, Is a medically important event. - Phase 2: Percentage of Participants Who Achieved a Complete Remission (CR) Per Independent Review Facility (IRF) Assessment Per International Working Group (IWG) Criteria at End of Treatment (EOT) Visit — At end of treatment (EOT) visit 30 days after the last dose of study drug (at Month 7)
CR was defined as the disappearance of all evidence of disease as assessed by IRF as per IWG Criteria. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in the statistical analysis plan (SAP) , data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. - Phase 2: Percentage of Participants Whose Disease Was Positron Emission Tomography (PET) Negative After 2 Cycles of Protocol Therapy Per IRF Assessment — From first dose of study drug up to Cycle 2 Day 25 (Each Cycle length=28 days)
The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans. PET negative after Cycle 2 was defined as an IRF Deauville score of (1 or 2 or 3). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. - Phase 2: Percentage of Participants Who Achieved a Partial Remission (PR) Per IRF Assessment Per IWG Criteria at EOT Visit — At EOT visit 30 days after the last dose of study drug (at Month 7)
PR was defined as regression of measurable disease and no new sites as assessed by IRF as per IWG criteria. Percentage of participants in the response-evaluable population who achieved a partial response based on the IRF assessment at the EOT visit based on the IWG criteria are reported. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. - Phase 2: Percentage of Participants Who Achieved an Overall Response Rate (ORR) Per IRF Assessment Per IWG Criteria at EOT Visit — At EOT visit 30 days after the last dose of study drug (at Month 7)
Overall response rate was defined as the percentage of participants with CR or PR as assessed by IRF using IWG criteria. CR was defined as the disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new diseases. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. - Phase 2: Percentage of Participants Who Were Able to Complete 6 Cycles of Protocol Therapy at the Recommended Dose — From first dose of study drug up to Cycle 6 (Each Cycle length=28 days)
This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | |
| Hospital Sao Rafael S/A | Salvador | Estado de Bahia | |
| Jardim das Americas | Paranã | Brazil | |
| INCA - Instituto Nacional de Cancer | Rio de Janeiro | Brazil | |
| GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer | São Paulo | Brazil | |
| ICr - Instituto da Crianca - HCFMUSP | São Paulo | Brazil | |
| Hospital Santa Marcelina | São Paulo | Brazil | |
| Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer | Florence | Italy | |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | |
| Ospedale Pediatrico Bambino Gesu,UOC Onco-ematologia | Roma | Italy | |
| Azienda Ospedaliera Citta della Salute e della Scienza di Torino | Torino | Italy | |
| NHO Nagoya Medical Center | Nagoya | Aichi-ken | |
| St. Marianna University School of Medicine Hospital | Kawasaki-shi | Kanagawa |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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