TREBL-1 (NHL31)

TREBL-1 (NHL31)

An Open label, Multicentre, Phase I study of Ibrutinib, Rituximab, Valaciclovir and 3rd Party EBV specific T cells in Patients with immunosuppression related EBV-positive Brain and/or Systemic B cell lymphomas, that are relapsed/refractory or unsuitable for standard first-line treatments.

Disease:

EBV-positive Brain and/or Systemic B cell lymphomas

Summary:

Lymphoma is a type of cancer that affects the lymphatic system, particularly the lymph nodes. The lymphatic system helps to fight infections and disease.
This research project is testing a new treatment for EBV-positive Lymphomas. The new treatment is a combination of rituximab (an antibody), an oral capsule called ibrutinib, valaciclovir (an anti-viral drug) and 3rd Party EBV specific T cells (a type of white blood cell).

Eligibility:

Include, but not limited to, the following:

Inclusion Criteria:
1. Histologically confirmed immunosuppressed EBV+ve B cell NHLs or Hodgkin Lymphoma *See Eligibility Protocol for further information
2. Systemic and/or CNS lymphoma, including ocular lymphoma.
3. Patient has relapsed/refractory or (at physician’s discretion) unsuitable for standard first-line treatments.
4. At least 1 measurable site of disease greater than 1.5 cm in the long axis. Any clinical stage permitted. *See Eligibility Protocol for further information
5. Age ≥18 years.
6. ECOG performance status 0-3.
7. Minimum life expectancy of 3 months.
8. Haematology values must be within limits as per Protocol *See Eligibility Protocol for further information
9. Patients meet the criteria regarding CYP3A inhibitors *See Eligibility Protocol for further information
10. Patients agree to birth control methods as detailed in Protocol *See Eligibility Protocol for further information
11. Patients meet the HIV+ and Hepatitis requirements as per protocol * See Eligibility Protocol for further information

Exclusion criteria:
1. Primary Effusion, Burkitt’s, and ENKT lymphomas.
2. Contraindication to any drug in the proposed regimen.
3. Serious active co-morbid disease according to the investigator’s decision.
4. Poor hepatic function, defined in Protocol *See Protocol Eligibility for further info
5. History of malignancy during the past 2 years, with the exception of non-melanoma skin cancers or stage 0 (in situ) carcinoma.
6. Treatment with any investigational drug within 30 days before the planned first cycle of chemotherapy.
7. Requires anticoagulation with warfarin or equivalent vitamin K antagonists.
8. Requires treatment with fish oil.
9. History of stroke or intracranial haemorrhage within 6 months of enrolment.
10. Currently unable to swallow capsules or current malabsorption syndrome due to ongoing disease significantly affecting gastrointestinal function *See Protocol Eligibility for further info
11. Known severe bleeding disorders (e.g. severe von Willebrand’s disease).
12. Major surgery within 4 weeks of enrolment.
13. Any life-threatening illness, medical condition, or organ system dysfunction *See Protocol Eligibility for further info
14. Clinically significant cardiovascular disease *See Protocol Eligibility for further info 15. Any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
16. Vaccinated with live, attenuated vaccines within 4 weeks of enrolment.
17. HIV+ patients that do not meet eligibility requirements *See Protocol Eligibility for further info

Contact person:

Louise Hay
Email louise.hay@health.wa.gov.au
Phone 08 6383 3207


Email
Phone

Principal Investigator:

A/Prof Chan Cheah

08 6457 7600

Sponsor:

ALLG

Phase:

1

Protocol Number:

NHL31

Trial Registration Number:

ACTRN12618001541291

Clinical Trials.gov

ANZ Clinical Trial Registry