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Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients (FIL_A-BEGEV)

Primary Purpose

Relapsed or Refractory Hodgkin's Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Atezolizumab
BEGEV
Sponsored by
Fondazione Italiana Linfomi - ETS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Hodgkin's Lymphoma focused on measuring Hodgkin's lymphoma, atezolizumab, BEGEV, phase I/II b study, relapsed, refractory, MTD

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-60 years old (upper limit valid only for phase I).
  • Histologically confirmed cHL, at first disease relapse or refractory to a first-line treatment or with documented persistent disease at interim positron emission tomography (PET) performed after 2 cycles of first line (ABVD/ABVD like/BEACOPP).
  • Only one prior systemic therapy for Hodgkin's lymphoma (HL).
  • First disease relapse or refractory to a first-line treatment.
  • Eligibility for ASCT.
  • Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Adequate haematological function, unless abnormalities due to underlying disease, at the moment of signing informed consent, defined as follows:

    • neutrophils > or = 1.500/mmc and
    • platelets > or = 75.000/mmc and
    • haemoglobin > or = 8,0 g/dL with transfusion independence
  • Capacity and willingness to adhere to study visit schedule and specific protocol procedures.
  • Compliance with effective contraception without interruption, from 28 days before treatment start up to 3 months after treatment discontinuation, agreeing not to donate semen/eggs during treatment and for 3 months after last treatment dose.

Exclusion Criteria:

  • More than one prior systemic therapy for HL.
  • Presence of autoimmune disease (based on medical history): systemic lupus erythematosus, autoimmune thyroid disease (Hashimoto's thyroiditis, Basedow's disease), Sjögren's syndrome, glomerulonephritis, multiple sclerosis, rheumatoid arthritis, vasculitis, idiopathic pulmonary fibrosis (includine bronchiolitis obliterans organizing pneumonia) and inflammatory bowel disease (Crohn's disease, ulcerative colitis).
  • Previous skin toxicity (i.e. Steven-Johnson Sdr, severe skin reactions.
  • Prior allogeneic stem cell transplantation or prior solid organ transplant.
  • History of active tubercolosis.
  • History of leptomeningeal disease.
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment.
  • Central nervous system (CNS) involvement by lymphoma.
  • Major surgery (excluding any lymph node biopsy) within 28 days prior to signing informed consent.
  • Seropositivity for HBV or evidence of active infection. The following categories may be considered for the study:

    • HBsAg positive with HBV DNA < 2000 UI/ml (inactive carriers); HBV DNA > 2000 UI/ml is criteria of exclusion
    • HBsAg negative but HBsAb positive
    • HBsAg negative but HBcAb positive HBsAg positive with HBV DNA < 2000 UI/ml and HBsAg negative but HBcAb positive will be eligible for the study only if they accept to receive antiviral prophylaxis for all the period of treatment and at least for 12 months after the end of therapy. Treatment should be stopped in case of hepatitis reactivation. - Seropositivity for HCV. Patients with presence of HCV antibody are eligible only if PCR result are negative for HCV RNA
  • Seropositivity for HIV.
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail bed) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics except if for tumor fever) within 2 weeks of the start of Cycle 1.
  • Life expectancy lower than 6 months.
  • Prior history of malignancies, other than HL, unless the patient has been free for at least 5 years (exceptions: localized non-melanoma skin cancer ad carcinoma in situ of the cervix).
  • Any of the following laboratory abnormalities: liver enzymes (AST/SGOT and/or ALT/SGPT) > 3 fold the upper limit of normal (except of liver involvement by lymphoma); total bilirubin > 1.5 mg/dL (except for patients with known Gilbert's disease or biliary tree compression by lymphoma masses); creatinine clearance < 30 mL/min.
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
  • Pregnancy or breastfeeding, or unwillingness to comply with adequate contraception (one negative pregnancy test within 14 days prior to initiation of study treatment required).
  • Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or which may place the patient at unacceptable risk if participating in the study.

Exception to Exclusion:

  • Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:

    • Rash must cover < 10% of body surface area
    • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
    • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
  • Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease (COPD) exacerbation) are eligible for the study.

Sites / Locations

  • Ematologia - Fondazione del Piemonte per l'Oncologia - IRCCS
  • S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo
  • S.C. Ematologia e Trapianto emopoietico - Azienda Ospedaliera S.Giuseppe Moscati
  • Divisione di Oncologia e dei Tumori immuto-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
  • U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
  • Ematologia - Ospedale "Monsignor Raffaele Dimiccoli"
  • Ematologia - ASST Spedali Civili di Brescia
  • Ematologia - Ospedale Vito Fazzi
  • Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
  • SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
  • U.O. Onco-ematologia - Presidio ospedaliero "A. TORTORA"
  • Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello
  • Div. di Ematologia - IRCCS Policlinico S. Matteo di PaviaRecruiting
  • Ematologia - Ospedale S. Maria della Misericordia
  • Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
  • Ematologia - Ospedale S. Camillo
  • Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza"
  • U.O. Ematologia - Istituto Clinico HumanitasRecruiting
  • S.C. Oncoematologia - A.O. S. Maria di Terni
  • S.C.Ematologia - A.O.U. Città della Salute e della Scienza di Torino

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

phase I

phase IIb - arm A

phase IIb - arm B

Arm Description

patients will receive the BEGEV regimen plus Atezolizumab in order to determine MTD of the last one drug.

patients will receive the BEGEV regimen followed by ASCT for patients achieving CR.

patients will receive combination treatment with Atezolizumab (at dose obtained from phase I) and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks.

Outcomes

Primary Outcome Measures

For Phase I part: evaluation of the maximum tolerated dose (MTD) of the atezolizumab.
The maximum tolerated dose (MTD) of the atezolizumab in combination with BEGEV will be established in the first cycle of therapy, in order to determine the recommended phase II dose (RP2D). Patients will be accrued in 3 patients cohorts at each dose level, starting from level 1. Dose de-escalation will be performed following the standard 3+3 rule, registering any Dose Limiting Toxicity (DLT).
For Phase II part: evaluation of the Complete Response Rate (CRR) before ASCT.
The assessment of CRR before ASCT will be performed by an independent radiologic review committee (IRRC) according to the Lugano classification response criteria (2014) and the LYmphoma Response to Immunomodulatory Therapy Criteria (LYRIC 2016). CRR will be defined as the proportion of patients in CR after the first 4 cycles of induction treatment, according to Lugano classification response Criteria and LYRIC 2016 criteria. Patients without response assessment (due to whatever reason) will be considered as non-responders.

Secondary Outcome Measures

For Phase II part: evaluation of the overall response rate (ORR), partial response (PR), stable disease (SD) and progression disease (PD) rates.
The assessment of the overall response rate (ORR), partial response (PR), stable disease (SD) and progression disease (PD) rates will be performed according to the Lugano 2014 criteria and LYRIC 2016 criteria.
For Phase II part: evaluation of the rate of partial response (PR) converted to Complete Response (CR).
The rate of PR converted to CR will be assessed as the number of PR converted in CR at the end of consolidation treatment with atezolizumab in the experimental arm.
For Phase II part: evaluation of the peripheral blood stem-cell mobilization
The peripheral blood stem-cell mobilization will be assessed in patients receiving atezolizumab combined to BEGEV schedule. Adequate stem cells mobilization will be defined by the target cell harvesting of 3 x 1.000.000 CD34+ cells/kg.
For Phase II part: evaluation of engraftment after ASCT
Engraftment will be assessed in patients who received ASCT after salvage treatment with atezolizumab combined to BEGEV. Engraftment will be defined as the first of three consecutive days of achieving a sustained peripheral blood neutrophil count of >500 × 1.000.000/L. Platelet engraftment is usually defined as independence from platelet transfusion for at least 7 days with a platelet count of more than >20 × 1.000.000.000/L.
For Phase II part: evaluation of duration of response (DoR).
The duration of response will be defined as the time from date of documented tumor response (CR) until lymphoma relapse or progression.
For Phase II part: evaluation of Progression Free Survival (PFS) for all patients.
PFS will be assessed for all patients and it will be defined as the time from beginning of therapy until lymphoma relapse or progression or death as a result of any cause; responding patients and patients who are lost to follow up will be censored at their last assessment date. It will be measured also in long-tem follow up in order to better assess patients' prognosis.
For Phase II part: evaluation of OS.
OS will be assessed for all patients and it will be defined as the time from beginning of therapy until death as a result of any cause; alive patients and those who are lost to follow up will be censored at their last assessment date. it will be measured also in long-tem follow up in order to better assess patients' prognosis.
For Phase II part: evaluation of safety and tolerability of atezolizumab and BEGEV.
The safety and the tolerability of a first salvage treatment based on the combination of intravenous (IV) atezolizumab and BEGEV regimen will be assessed throughout the study by the measurement of: patients' withdrawal rate, incidence, type and grade of any adverse event (AE) and serious adverse event (SAE) assessed by CTCAE v.4.0, hospitalization rate (except it for study therapy administration).

Full Information

First Posted
March 8, 2022
Last Updated
September 13, 2023
Sponsor
Fondazione Italiana Linfomi - ETS
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT05300282
Brief Title
Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients
Acronym
FIL_A-BEGEV
Official Title
A Phase I/II b (Randomized Controlled) Study of Atezolizumab Combined to BEGEV Regimen as First Salvage Treatment in Patients With Relapsed or Refractory Hodgkin's Lymphoma Candidate to Autologous Stem-Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
May 8, 2025 (Anticipated)
Study Completion Date
December 8, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Italiana Linfomi - ETS
Collaborators
Roche Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The phase I part (safety assessment of the combination treatment) is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule. 6-18 patients enrolled in this part will be treated with atezolizumab in combination with BEGEV regimen every 3 weeks for 4 cycles. Patients without a DLT in the first cycle and without disease progression after cycle 2, will undergo stem cell mobilization with 3-4 cycle of A-BEGEV + granulocyte colony-stimulating factor (G-CSF) and subsequently receive a myeloablative therapy followed by ASCT. The phase IIb part (expansion cohort) plans to randomize 122 patients in two arms (A and B, 61 per arm): arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR. arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks. After the last treatment date of the last patient (LPLT), the phase IIb will be ended. A long term follow up will start, in order to better assess patients' prognosis. All evaluable patients from phase I and phase IIb study will enter in the long term follow up phase and will be followed for 18 months.
Detailed Description
The phase I part (safety assessment of the combination treatment) is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule. 6-18 patients enrolled in this phase will be treated with atezolizumab in combination with BEGEV regimen every 3 weeks for 4 cycles. Patients without a DLT in the first cycle and without disease progression after cycle 2, will undergo stem cell mobilization with 3-4 cycle of A-BEGEV + granulocyte colony-stimulating factor (G-CSF) and subsequently receive a myeloablative therapy followed by ASCT. Patients with documented CR following ASCT will receive a consolidation therapy with atezolizumab as single agent every 4 weeks for 6 doses, starting preferably between 60 and 90 days, but ≥ 60 days and not > 120 days after autografting. In patients not previously radiotreated, adjuvant radiotherapy (RT) should be planned during consolidation treatment within the start of second consolidation dose, according to clinician's judgment and response assessment. RT will be administered at 30-36 Gy on sites of initial bulky disease or on single PET positive residual site. Patients reaching PR after four cycles of atezolizumab combined with BEGEV or with documented PR after ASCT may continue the study protocol according to the physician judgment. Dosing starts at 1200 mg and decreases in the successive cohort to the dose of 840 mg and 600 mg, according to Flow chart A. in the section 6 of the protocol. In the consolidation phase atezolizumab will be administered at dose of 1200 mg every 4 weeks for 6 doses without dose reduction, but only delay or discontinuation. Patients included in the cohort developing DLT, withdraw the protocol due to toxicity and continue the treatment according to good clinical practice. For patients included in the cohort of MTD, monitoring and collection of AEs will be continuous during induction, consolidation treatment and follow-up. The phase IIb part (expansion cohort) plans to randomize 122 patients in two arms (A and B, 61 per arm): arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR. arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks. In patients not previously radiotreated, adjuvant RT should be planned for both patients in arm A and arm B according to clinician's judgment and response assessment. RT will be administered at 30-36 Gy on sites of initial bulky disease or on single PET positive residual site. Patients reaching PR after four induction cycles (atezolizumab combined with BEGEV or BEGEV alone) or with documented PR after ASCT may continue the study protocol according to the physician judgment. After the last treatment date of the last patient (LPLT), the phase IIb will be ended. A long term follow up will start, in order to better assess patients' prognosis. All evaluable patients from phase I and phase IIb study will enter in the long term follow up phase and will be followed for 18 months. Disease status, survival outcome, secondary primary malignancies and late toxicity will be collected every 6 months until patient withdrawal of consent, lost to follow up and patient's death. Long term follow-up phase will end 18 months after the end of phase IIb.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Hodgkin's Lymphoma
Keywords
Hodgkin's lymphoma, atezolizumab, BEGEV, phase I/II b study, relapsed, refractory, MTD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
The phase I part is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule. Atezolizumab dosing starts at 1200 mg and decreases in the successive cohort to the dose of 840 mg and 600 mg to reach MTD which will be used in the phase II part where patients will be randomized in 2 arms: arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR and arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
phase I
Arm Type
Experimental
Arm Description
patients will receive the BEGEV regimen plus Atezolizumab in order to determine MTD of the last one drug.
Arm Title
phase IIb - arm A
Arm Type
Active Comparator
Arm Description
patients will receive the BEGEV regimen followed by ASCT for patients achieving CR.
Arm Title
phase IIb - arm B
Arm Type
Experimental
Arm Description
patients will receive combination treatment with Atezolizumab (at dose obtained from phase I) and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
In phase I study: Atezolizumab will be administered until the determination of its MTD when combined with BEGEV schedule. In phase II b study - arm A (standard): Atezolizumab will not be administered. In phase II b study - arm B (experimental): Atezolizumab will be administered at MTD determined in phase I study plus BEGEV regimen (at dosages performed by local practice).
Intervention Type
Combination Product
Intervention Name(s)
BEGEV
Other Intervention Name(s)
Bendamustine, Gemcitabine, Vinorelbine
Intervention Description
In phase I study: Atezolizumab will be administered until the determination of its MTD when combined with BEGEV schedule. In phase II b study - arm A (standard): only BEGEV will be administered. In phase II b study - arm B (experimental): BEGEV regimen will be administered in combination with Atezolizumab at MTD determined in phase I.
Primary Outcome Measure Information:
Title
For Phase I part: evaluation of the maximum tolerated dose (MTD) of the atezolizumab.
Description
The maximum tolerated dose (MTD) of the atezolizumab in combination with BEGEV will be established in the first cycle of therapy, in order to determine the recommended phase II dose (RP2D). Patients will be accrued in 3 patients cohorts at each dose level, starting from level 1. Dose de-escalation will be performed following the standard 3+3 rule, registering any Dose Limiting Toxicity (DLT).
Time Frame
During first cycle of treatment based on atezolizumab in combination with BEGEV in phase I study. Maximum time frame 17 months.
Title
For Phase II part: evaluation of the Complete Response Rate (CRR) before ASCT.
Description
The assessment of CRR before ASCT will be performed by an independent radiologic review committee (IRRC) according to the Lugano classification response criteria (2014) and the LYmphoma Response to Immunomodulatory Therapy Criteria (LYRIC 2016). CRR will be defined as the proportion of patients in CR after the first 4 cycles of induction treatment, according to Lugano classification response Criteria and LYRIC 2016 criteria. Patients without response assessment (due to whatever reason) will be considered as non-responders.
Time Frame
From initial treatment based on Atezolizumab and BEGEV to intensification treatment with ASCT. Time frame 4 months.
Secondary Outcome Measure Information:
Title
For Phase II part: evaluation of the overall response rate (ORR), partial response (PR), stable disease (SD) and progression disease (PD) rates.
Description
The assessment of the overall response rate (ORR), partial response (PR), stable disease (SD) and progression disease (PD) rates will be performed according to the Lugano 2014 criteria and LYRIC 2016 criteria.
Time Frame
The best response between the date of beginning of therapy and the last restaging. Time frame 14 months.
Title
For Phase II part: evaluation of the rate of partial response (PR) converted to Complete Response (CR).
Description
The rate of PR converted to CR will be assessed as the number of PR converted in CR at the end of consolidation treatment with atezolizumab in the experimental arm.
Time Frame
At the end of consolidation treatment with atezolizumab in the experimental arm. Time Frame 14 months.
Title
For Phase II part: evaluation of the peripheral blood stem-cell mobilization
Description
The peripheral blood stem-cell mobilization will be assessed in patients receiving atezolizumab combined to BEGEV schedule. Adequate stem cells mobilization will be defined by the target cell harvesting of 3 x 1.000.000 CD34+ cells/kg.
Time Frame
At the end of treatment based on atezolizumab and BEGEV. Time Frame 3 months.
Title
For Phase II part: evaluation of engraftment after ASCT
Description
Engraftment will be assessed in patients who received ASCT after salvage treatment with atezolizumab combined to BEGEV. Engraftment will be defined as the first of three consecutive days of achieving a sustained peripheral blood neutrophil count of >500 × 1.000.000/L. Platelet engraftment is usually defined as independence from platelet transfusion for at least 7 days with a platelet count of more than >20 × 1.000.000.000/L.
Time Frame
Between 30 and 60 days after ASCT: Time Frame 5 months.
Title
For Phase II part: evaluation of duration of response (DoR).
Description
The duration of response will be defined as the time from date of documented tumor response (CR) until lymphoma relapse or progression.
Time Frame
From the CR to the date of relapse or progression or last scheduled visit. Time frame 50 months.
Title
For Phase II part: evaluation of Progression Free Survival (PFS) for all patients.
Description
PFS will be assessed for all patients and it will be defined as the time from beginning of therapy until lymphoma relapse or progression or death as a result of any cause; responding patients and patients who are lost to follow up will be censored at their last assessment date. It will be measured also in long-tem follow up in order to better assess patients' prognosis.
Time Frame
From beginning therapy to progression or relapse disease or death. Time frame 50 months.
Title
For Phase II part: evaluation of OS.
Description
OS will be assessed for all patients and it will be defined as the time from beginning of therapy until death as a result of any cause; alive patients and those who are lost to follow up will be censored at their last assessment date. it will be measured also in long-tem follow up in order to better assess patients' prognosis.
Time Frame
From the beginning of therapy to death for any cause or last scheduled visit. Time frame 50 months.
Title
For Phase II part: evaluation of safety and tolerability of atezolizumab and BEGEV.
Description
The safety and the tolerability of a first salvage treatment based on the combination of intravenous (IV) atezolizumab and BEGEV regimen will be assessed throughout the study by the measurement of: patients' withdrawal rate, incidence, type and grade of any adverse event (AE) and serious adverse event (SAE) assessed by CTCAE v.4.0, hospitalization rate (except it for study therapy administration).
Time Frame
From the beginning of treatment to death or lost to follow-up or last scheduled visit. Time frame 50 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-60 years old (upper limit valid only for phase I). Histologically confirmed cHL, at first disease relapse or refractory to a first-line treatment or with documented persistent disease at interim positron emission tomography (PET) performed after 2 cycles of first line (ABVD/ABVD like/BEACOPP). Only one prior systemic therapy for Hodgkin's lymphoma (HL). First disease relapse or refractory to a first-line treatment. Eligibility for ASCT. Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale. Adequate haematological function, unless abnormalities due to underlying disease, at the moment of signing informed consent, defined as follows: neutrophils > or = 1.500/mmc and platelets > or = 75.000/mmc and haemoglobin > or = 8,0 g/dL with transfusion independence Capacity and willingness to adhere to study visit schedule and specific protocol procedures. Compliance with effective contraception without interruption, from 28 days before treatment start up to 3 months after treatment discontinuation, agreeing not to donate semen/eggs during treatment and for 3 months after last treatment dose. Exclusion Criteria: More than one prior systemic therapy for HL. Presence of autoimmune disease (based on medical history): systemic lupus erythematosus, autoimmune thyroid disease (Hashimoto's thyroiditis, Basedow's disease), Sjögren's syndrome, glomerulonephritis, multiple sclerosis, rheumatoid arthritis, vasculitis, idiopathic pulmonary fibrosis (includine bronchiolitis obliterans organizing pneumonia) and inflammatory bowel disease (Crohn's disease, ulcerative colitis). Previous skin toxicity (i.e. Steven-Johnson Sdr, severe skin reactions. Prior allogeneic stem cell transplantation or prior solid organ transplant. History of active tubercolosis. History of leptomeningeal disease. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Central nervous system (CNS) involvement by lymphoma. Major surgery (excluding any lymph node biopsy) within 28 days prior to signing informed consent. Seropositivity for HBV or evidence of active infection. The following categories may be considered for the study: HBsAg positive with HBV DNA < 2000 UI/ml (inactive carriers); HBV DNA > 2000 UI/ml is criteria of exclusion HBsAg negative but HBsAb positive HBsAg negative but HBcAb positive HBsAg positive with HBV DNA < 2000 UI/ml and HBsAg negative but HBcAb positive will be eligible for the study only if they accept to receive antiviral prophylaxis for all the period of treatment and at least for 12 months after the end of therapy. Treatment should be stopped in case of hepatitis reactivation. - Seropositivity for HCV. Patients with presence of HCV antibody are eligible only if PCR result are negative for HCV RNA Seropositivity for HIV. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail bed) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics except if for tumor fever) within 2 weeks of the start of Cycle 1. Life expectancy lower than 6 months. Prior history of malignancies, other than HL, unless the patient has been free for at least 5 years (exceptions: localized non-melanoma skin cancer ad carcinoma in situ of the cervix). Any of the following laboratory abnormalities: liver enzymes (AST/SGOT and/or ALT/SGPT) > 3 fold the upper limit of normal (except of liver involvement by lymphoma); total bilirubin > 1.5 mg/dL (except for patients with known Gilbert's disease or biliary tree compression by lymphoma masses); creatinine clearance < 30 mL/min. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation Pregnancy or breastfeeding, or unwillingness to comply with adequate contraception (one negative pregnancy test within 14 days prior to initiation of study treatment required). Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or which may place the patient at unacceptable risk if participating in the study. Exception to Exclusion: Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: Rash must cover < 10% of body surface area Disease is well controlled at baseline and requires only low-potency topical corticosteroids No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease (COPD) exacerbation) are eligible for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uffici Studi FIL
Phone
0131033153
Email
startup@filinf.it
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenza Randi, Dr.
Phone
0131033153
Email
lrandi@filinf.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Organizational Affiliation
U.O. Ematologia - Istituto Clinico Humanitas - Rozzano - ITALY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ematologia - Fondazione del Piemonte per l'Oncologia - IRCCS
City
Candiolo
State/Province
Turin
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delia Rota Scalabrini, Dr.
Email
delia.rotascalabrini@ircc.it
Facility Name
S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zanni Manuela, Dr.
Email
manuela.zanni@ospedale.al.it
Facility Name
S.C. Ematologia e Trapianto emopoietico - Azienda Ospedaliera S.Giuseppe Moscati
City
Avellino
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonya De Lorenzo, Dr.
Email
sonya.delorenzo@tin.it
Facility Name
Divisione di Oncologia e dei Tumori immuto-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
City
Aviano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Spina, Dr.
Email
mspina@cro.it
Facility Name
U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
City
Bari
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Attilio Guarini, Dr.
Email
attilioguarini@oncologico.bari.it
Facility Name
Ematologia - Ospedale "Monsignor Raffaele Dimiccoli"
City
Barletta
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano De Santis, dR.
Email
desantis.emat@gmail.com
Facility Name
Ematologia - ASST Spedali Civili di Brescia
City
Brescia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Re, Dr.
Email
alessandro.re@asst-spedalicivili.it
Facility Name
Ematologia - Ospedale Vito Fazzi
City
Lecce
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Di Renzo, Dr.
Email
direnzo.ematolecce@gmail.com
Facility Name
Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Corradini, Prof.
Email
paolo.corradini@unimi.it
Facility Name
SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vittorio Ruggero Zilioli, Dr.
Email
vittorioruggero.zilioli@ospedaleniguarda.it
Facility Name
U.O. Onco-ematologia - Presidio ospedaliero "A. TORTORA"
City
Pagani
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catello Califano, Dr.
Email
c.califano@aslsalerno.it
Facility Name
Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello
City
Palermo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caterina Patti, Dr.
Email
k.patti@villasofia.it
Facility Name
Div. di Ematologia - IRCCS Policlinico S. Matteo di Pavia
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Gotti, Dr
Email
manuel.gotti@hotmail.it
Facility Name
Ematologia - Ospedale S. Maria della Misericordia
City
Perugia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo Flenghi, Dr
Email
leonardo.flenghi@ospedale.perugia.it
Facility Name
Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
City
Reggio Emilia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Luminari, Prof.
Email
stefano.luminari@ausl.re.it
Facility Name
Ematologia - Ospedale S. Camillo
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Rigacci, Dr.
Email
lrigacci@scamilloforlanini.rm.it
Facility Name
Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza"
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Pulsoni, Prof.
Email
alessandro.pulsoni@uniroma1.it
Facility Name
U.O. Ematologia - Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, Dr.
Email
armando.santoro@cancercenter.humanitas.it
Facility Name
S.C. Oncoematologia - A.O. S. Maria di Terni
City
Terni
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Marina Liberati, Prof.
Email
marina.liberati@unipg.it
Facility Name
S.C.Ematologia - A.O.U. Città della Salute e della Scienza di Torino
City
Torino
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Botto, Dr.
Email
bbotto@cittadellasalute.to.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients

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