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RecruitingLast updated: 30 November 2023

ALLG HD12: This study aims to assess the effect of immunotherapy in combination with chemotherapy for the treatment of elderly patients with early- or advanced-stage Hodgkin LymphomaAn ALLG phase II study of CHOP And Tislelizumab in elderly patients with Hodgkin Lymphoma

Clinical summary

Summary

Eligible participants will first receive 3 cycles (each cycle is 3 weeks) of intravenous (IV) immunotherapy called tislelizumab, which will be given on Day 1 of each cycle.

Following this, treatment with tislelizumab will continue for another 4-6 cycles in combination with chemotherapy (either CHOP or mini-CHOP regimens). CHOP and mini-CHOP both include the same combination of chemotherapy drugs (doxorubicin, vincristine, cyclophosphamide and prednisone), but mini-CHOP is a lower-dose version that may be given to patients over the age of 80 or who would not tolerate the full dose CHOP regimen.

This will be followed by a further four cycles of tislelizumab, or may be followed by radiation therapy at the discretion of the Investigator.

For participants who achieve a complete response, the total duration of therapy will be 21 weeks for those with early-stage disease or 27 weeks for those with advanced-stage disaease. All participants will be followed-up for a minimum of 2 years after the end of treatment, which will continue until the last patient has compelted their 2-year follow-up. PET-CT scans will be used to monitor the response to treatment thorughout, and any side effects of treatment will be monitored thorugh regular physical examinations, blood tests and a questionnaire.

Conditions

This trial is treating patients with Hodgkin's Lymphoma

Cancer

Blood Cancers Haematological

Age

People61+

Phase

II

Trial Acronym

ALLG HD12

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Australasian Leukaemia and Lymphoma Group

Scientific Title

An ALLG phase II study of CHOP And Tislelizumab in elderly patients with Hodgkin Lymphoma

Eligibility

Inclusion

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

Exclusion

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.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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