Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 60 years old (the upper age limit of 60 applies to the first phase of the trial only)
• People who have been diagnosed with classical Hodgkin lymphoma (cHL), confirmed by a tissue biopsy
• People whose Hodgkin lymphoma has come back after treatment, has not responded to their first treatment, or showed ongoing disease on a PET scan taken after 2 cycles of their first chemotherapy course (ABVD, ABVD-like, or BEACOPP)
• People who have received only one prior course of treatment for Hodgkin lymphoma
• People whose doctors consider them suitable for an autologous stem cell transplant (a procedure using the patient's own stem cells)
• People who are generally well enough to carry out some daily activities, as measured by a standard medical scoring tool (ECOG performance status of 2 or lower)
• People with blood counts that are adequate at the time of signing consent — specifically, neutrophils at or above 1,500/mmc, platelets at or above 75,000/mmc, and haemoglobin at or above 8.0 g/dL without needing recent blood transfusions
• People who are willing and able to attend study visits and follow the study procedures
• People who agree to use effective contraception from 28 days before treatment starts until at least 6 months after treatment ends, and who agree not to donate sperm or eggs during treatment and for at least 6 months after the last dose

Who may not be able to join:

• People who have received more than one prior course of treatment for Hodgkin lymphoma
• People with a history of certain autoimmune conditions, including lupus, autoimmune thyroid disease (such as Hashimoto's or Graves' disease), Sjögren's syndrome, certain kidney inflammations, multiple sclerosis, rheumatoid arthritis, vasculitis, idiopathic pulmonary fibrosis, or inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
• People with a history of severe skin reactions, such as Stevens-Johnson Syndrome
• People who have previously had an allogeneic stem cell transplant (using donor stem cells) or a solid organ transplant (such as a kidney or liver transplant)
• People with a history of active tuberculosis
• People with a history of cancer spreading to the membranes surrounding the brain or spinal cord
• People who have been treated with antibiotic tablets or infusions within the 2 weeks before starting the study treatment (though people taking antibiotics to prevent infections, such as urinary tract infections, may still be eligible — confirm with trial site)
• People whose lymphoma has spread to the brain or spinal cord
• People who have had major surgery (not counting lymph node biopsies) within 28 days before signing the consent form
• People who test positive for hepatitis B virus (HBV) with a high viral load (HBV DNA above 2,000 IU/ml); some people with lower viral levels or certain hepatitis B antibody patterns may still be considered, but only if they agree to take antiviral medication throughout treatment and for at least 12 months after — the trial site can advise on this
• People who test positive for hepatitis C virus (HCV) antibodies and also have active HCV infection detected by a PCR blood test
• People who test positive for HIV
• People with a known active infection (bacterial, viral, fungal, or other), or who have needed intravenous antibiotics or hospitalisation for an infection within the 2 weeks before starting the trial
• People with a life expectancy of less than 6 months
• People with a history of another cancer (other than Hodgkin lymphoma), unless they have been cancer-free for at least 5 years — exceptions include certain localised skin cancers and cervical carcinoma in situ
• People with certain abnormal blood test results related to liver function (ALT or AST more than 3 times the upper normal limit, unless caused by lymphoma), high bilirubin levels (unless due to a known condition called Gilbert's disease or lymphoma pressing on bile ducts), or significantly reduced kidney function (creatinine clearance below 30 mL/min)
• People with significant heart or cardiovascular problems within the 3 months before starting treatment, including heart failure, heart attack, stroke, unstable heart rhythm, or unstable chest pain
• People with a history of severe allergic reactions to certain types of antibody-based medicines
• People with a known allergy to the drug atezolizumab or any of its ingredients, or to products derived from Chinese hamster ovary cells (used in producing certain medicines)
• People who are pregnant or breastfeeding, or who are not willing to use adequate contraception; a negative pregnancy test within 14 days before starting treatment is required
• People with a serious medical condition, significant abnormal test results, or a psychiatric illness that would prevent safe participation in the study

Exceptions — some people who would otherwise be excluded may still be eligible:

• People with autoimmune-related underactive thyroid who are already on thyroid replacement medication may still be eligible
• People with well-controlled Type 1 diabetes who are on insulin may still be eligible
• People with certain mild skin conditions (eczema, psoriasis, lichen simplex chronicus, or vitiligo affecting the skin only) may still be eligible, provided the rash covers less than 10% of the body, the condition is well controlled with only mild topical creams, and there has been no severe flare-up requiring stronger treatments in the past 12 months — confirm details with the trial site

Important: Always verify eligibility with the trial site directly before applying.