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New treatment option for Relapsed or Refractory Hodgkin's Lymphoma
Official title Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients
ClinicalTrials.gov ID: NCT05300282
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, being studied as a potential treatment for relapsed or refractory hodgkin's lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- Only one prior systemic therapy for Hodgkin's lymphoma (HL).
- First disease relapse or refractory to a first-line treatment.
- Eligibility for ASCT.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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, according to physician's judgement, from 28 days before treatment start up to at least 6 months after treatment discontinuation, agreeing not to donate...
- 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...
- 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 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease (COPD) exacerbation) are eligible for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Alessandria, Alessandria, Italy
- Candiolo, Turin, Italy
- Avellino, Italy
- Aviano, Italy
- Bari, Italy
- Barletta, Italy
- Brescia, Italy
- Latina, Italy
- Lecce, Italy
- Meldola, Italy
- Messina, Italy
- Milan, Italy
- Naples, Italy
- Pagani, Italy
- Palermo, Italy
- Pavia, Italy
- Perugia, Italy
- Piacenza, Italy
- Ravenna, Italy
- Reggio Emilia, Italy
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alessandria, Alessandria, Italy; Candiolo, Turin, Italy; Avellino, Italy; Aviano, Italy; Bari, Italy; Barletta, Italy and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.