A study of a chemotherapy regime and tislelizumab in elderly patients with Hodgkin Lymphoma
- Conditions
- Hodgkin LymphomaCancer - Hodgkin's
- Registration Number
- ACTRN12622000207718
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
1.Histologically confirmed diagnosis of classical HL according to the current World Health Organisation (WHO). Diagnosis must be made on a core or excision biopsy of a suitable target lesion.
2.Aged 61 years or older
3.Clinical stage IIA (unfavourable as per German Hodgkin Study Group (GHSG) criteria) to IVB
4.Has provided written informed consent
5.Life expectancy at least 3 months
6.Men who are sexually active with women of child-bearing potential must use any highly effective contraceptive method during the study (failure rate less than 1% per year) and for a period of 120 days after the last dose of therapy
7.PET-CT avid disease at baseline.
8.Adequate haematological, renal, hepatic and cardiac function at Screening as defined by:
a.ANC (segs + bands) equal to or greater than 1.0 x 10^9/L
b.Platelet count equal to or greater than 75 x 10^9/L (or 50 if bone marrow is involved)
c.Total bilirubin equal to or less than 1.5 x ULN (unless rise in bilirubin is due to Gilbert’s syndrome or of non-hepatic origin
d.ALT and AST equal to or less than 3 x ULN
e.Creatinine clearance equal to or greater than 30ml / min / 1.73m2
f.LVEF within institutional normal limits (determined either by echocardiography or gated heart pool scan).
9.An ECOG performance status score of 0 or 1 at Screening
1.Central nervous system involvement
2.Requirement of urgent treatment due to life threatening complications of the disease.
3.Immunosuppressive therapy within the last 2 months, apart from inhaled or topical corticosteroids or systemic corticosteroids at low doses (equal to or greater than 10mg prednisone per day or equivalent)
4.Has active auto-immune disease that has required systemic treatment in the prior 2 years with immunosuppressive agents. Replacement therapy such as thyroxine, insulin or physiological steroid replacement for adrenal or pituitary insufficiency is not considered a form of systemic therapy, and hence patients on these therapies are allowed.
5.History of inflammatory bowel disease or pneumonitis
6.Prior treatments with chemotherapy or radiotherapy within 15 days prior to registration.
7.Prior anthracycline use equivalent to greater than 150mg/m2 of doxorubicin.
8.History of malignancy during the past 2 years except for locally curable cancers, that have had curative surgical treatment. Examples are:
-Treated carcinoma in situ at any site (e.g. cervix, breast)
Adequately treated non melanoma skin cancer
-Superficial bladder cancer, adequately treated with surgical/cauterisation. (BCG treatment is excluded)
-Untreated chronic lymphocytic leukaemia with a less than 50% rise in the lymphocyte count in the preceding 6 months
-Low risk early-stage prostate adenocarcinoma (Gleason score equal to or less than 6).
-Pre-malignant lesions (e.g. monoclonal gammopathy of uncertain significance, monoclonal B cell lymphocytosis) are allowed.
9.Uncontrolled active infection (defined as an infection that requires intravenous anti-microbial treatment,) at the time of first dose of therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method