Hodgkin LymphomaPhase 2RATiFYNCT05627115
Response Adapted Incorporation of Tislelizumab Into the Front-line Treatment of Older Patients With Hodgkin lYmphoma
A Phase 2 study testing Tislelizumab, AVD, Radiotherapy in people with Hodgkin Lymphoma, run by University College, London.
Trial summary
The goal of this clinical trial is to test the effect of tislelizumab treatment in patients with Hodgkin lymphoma. The main question it aims to answer is whether including a drug called tislelizumab in first-line treatment of Hodgkin lymphoma for patients age 60 years and older is effective and well-tolerated. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Tislelizumab, AVD, Radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed untreated classic Hodgkin lymphoma (Stage I-IV)
- Age 60 years or over
- In the view of the investigator, fit for combination chemotherapy (includes those who would require planned dose reduction although no lower than 50% doxorubicin)
- Written informed consent
- Measurable disease on contrast enhanced CT as defined by Cheson et al., 2014 1 (Nodal lesion of longest diameter 1.5 cm or extranodal lesion of longest diameter 1.0 cm).
- ECOG performance status 0-2
Show all 12Show fewer
- Adequate bone marrow function (Platelets ≥ 75 x 109/L without platelet transfusion for 72 hours, Neutrophils ≥ 1.0 x 109/L without G-CSF for 7 days)
- Adequate liver function tests (ALT / AST ≤ 2.5 x ULN, total serum bilirubin ≤ 1.5 x ULN)
- Creatinine Clearance ≥ 30 ml/min as defined by the Cockroft-Gault equation
- Adequate cardiac function as determined by a transthoracic echocardiogram demonstrating left ventricular ejection fraction is ≥ 50% and confirming the absence of severe valvular heart disease
- Willing to comply with the contraceptive requirements of the trial
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Who cannot join
- Nodular lymphocyte predominant Hodgkin lymphoma
- History of autoimmune disorders (with the exception of hypothyroidism, type 1 diabetes, vitiligo, alopecia)
- History of solid organ transplant
- Grade 2 or higher peripheral neuropathy
- Presentation with disease causing symptomatic compression of vital structures (e.g. stridor due to tracheal compression). Other cases of radiological compression of vital structures require discussion with TMG prior to registration
- Women who are pregnant or breastfeeding
Show all 26Show fewer
- Active hepatitis B or C infection defined by
- Hepatitis B surface antigen positivity OR
- Anti-hepatitis B core antibody positivity with detectable circulating HBV DNA (hepatitis B core antibody patients with undetectable circulating HBV DNA are eligible but must take suitable prophylaxis for reactivation)
- Anti-Hepatitis C antibody positivity unless patient has been treated for hepatitis C and has undetectable HCV RNA
- Known HIV infection
- Positive PCR for SAR-CoV-2 RNA within the 2 weeks prior to registration. Patients with a history of SARS-CoV-2 are required to have a documented negative PCR swab since documented SARS-CoV-2 infection
- Immunosuppressive therapy within the 2 months prior to registration apart from inhaled, intranasal or topical corticosteroids. Systemic corticosteroids are permitted prior to study entry but must be weaned to 10 mg prednisolone / day for a minimum of 7 days prior to cycle 1 day 1
- Live vaccine given within 30 days prior to registration
- Active infection requiring systemic therapy with ongoing symptoms at registration or where the planned duration of therapy would continue beyond cycle 1 day 1
- Major surgery within 4 weeks prior to registration (excisional biopsy is not considered major surgery)
- Myocardial infarction, unstable angina, coronary artery bypass graft, cerebrovascular accident or transient ischaemic attack within 6 months prior to registration
- Previously treated haematological malignancy
- Solid-organ malignancy active within the last 3 years, except where the natural history or treatment does not have the potential to interfere with assessment of safety or efficacy of trial treatment, for example:
- Adequately treated non-melanoma skin cancer considered to be in remission
- Melanoma in situ following resection
- Carcinoma in situ of the breast or cervix
- Carcinoma of the prostate of Gleason grade 6 or less with stable prostate-specific antigen levels
- Cancer considered cured by surgical resection or unlikely to impact survival in the next 3 years, for example local transitional carcinoma of the bladder or benign tumours of the adrenal gland or pancreas
- A history of other malignancies should be discussed with the trial management group prior to registration
- Patient not fit for AVD chemotherapy in the opinion of the investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Response Adapted Incorporation of Tislelizumab Into the Front-line Treatment of Older Patients With Hodgkin lYmphoma (RATiFY)
The goal of this clinical trial is to test the effect of tislelizumab treatment in patients with Hodgkin lymphoma. The main question it aims to answer is whether including a drug called tislelizumab in first-line treatment of Hodgkin lymphoma for patients age 60 years and older is effective and well-tolerated.
Participants will initially receive tislelizumab infusion every 21 days for 3 doses. After this a PET scan will be performed to assess the response. The subsequent treatment patients receive will depend on the following factors:
- The lymphoma stage (early stage or advanced stage)
- The presence or absence of specific high-risk features at the time of diagnosis
- How well the lymphoma responds to the initial 3 doses of tislelizumab
Read the detailed description
Trial patients who are deemed eligible for the trial will receive 3 cycles of tislelizumab which will be administered at a dose of 200 mg (IV) on day 1 of each 21-day cycle. Patients will then undergo a PET-CT scan (PET1). Subsequent treatment is determined by the patient's stage and response to tislelizumab (as determined by PET1).
Patients with early stage lymphoma and no high-risk features who respond very well to the initial 3 doses of tislelizumab will receive a further 2 doses of tislelizumab, followed by radiotherapy, followed by tislelizumab once every 21 days for up to 2 years.
All other patients will receive a combination of tislelizumab with chemotherapy for between 2 and 6 cycles. Each cycle will last 28 days. Tislelizumab will be given on day 1 and chemotherapy (doxorubicin (also known as Adriamycin), vinblastine and dacarbazine, or AVD) will be given on days 1 and 15, as injections or infusions into a vein. Following this some patients may require radiotherapy depending on their response to treatment.
Patients who are in complete metabolic response (CMR) at PET1 will receive 2 fewer cycles of tislelizumab and AVD therapy than those not in CMR.
A further 1 or 2 PET scans will be performed to assess how well the lymphoma has responded to the trial treatment, depending on the results of previous scans. After completing the treatment patients will then be followed-up for at least 2 years from the start of their participation in the trial.
Note: Initial patients will be recruited to a safety run in. Once 6 evaluable patients have completed 2 cycles of tislelizumab and AVD after PET1 the independent data monitoring committee (IDMC) will review the data, and if considered tolerable, recruitment will continue to the full sample size (80 patients).
- Conditions
- Hodgkin Lymphoma
- Being tested
- Tislelizumab, AVD, Radiotherapy
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab, AVD, RadiotherapyDrug
Also called Response-adapted incorporation of tislelizumab
GROUP A: Early stage disease without adverse features in CMR: 2 further cycles tislelizumab then radiotherapy then 200mg IV tislelizumab once every 3 weeks until a maximum of 2 years total treatment. PET-CT (PET2) 12 weeks after radiotherapy.
GROUP B: Early stage disease with adverse features in CMR: 2 cycles of AVD plus tislelizumab then radiotherapy. PET-CT (PET2) 12 weeks after the completion of radiotherapy.
GROUP C: All early stage disease not in CMR: 4 cycles of AVD plus tislelizumab then PET-CT and radiotherapy. PET-CT 12 (PET2) weeks after radiotherapy.
GROUP D: Advanced stage disease in CMR: 4 cycles of AVD plus tislelizumab then radiotherapy at investigator's discretion. PET-CT (PET2) 12 weeks after radiotherapy.
GROUP E: Advanced stage disease not in CMR: 6 cycles of AVD plus tislelizumab then PET-CT then radiotherapy at investigator's discretion. PET-CT (PET2) 12 weeks after radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab Response-Adapted Treatment | Experimental | All patients will receive 3 cycles of tislelizumab 200 mg (IV) every 21 days. They will then undergo a PET-CT scan (PET1).
Subsequent treatment with further tislelizumab, radiotherapy, and between 2-6 cycles of chemotherapy (Doxorubicin, Vinblastine, and Dacarbazine - AVD) is determined by the patient's stage and response at PET1. Receives: Drug: Tislelizumab, AVD, Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year event-free survival (EFS)
To determine the effect of tislelizumab on 2 year EFS using a response-adapted approach to treatment in the front-line treatment of older patients with Hodgkin lymphoma
Measured: 2 years after start of treatment
Secondary outcomes (13)
The number / percentage of patients with the worst grade of each adverse event
To assess the safety and tolerability of tislelizumab alone and in combination with AVD. Worst grades will be calculated and presented as the number/percentage of patients with each event.
Measured: From signing of informed consent until 30 calendar days post last IMP or post last investigational treatment administration (or after this date if the site investigator feels the event is related to an IMP and/or investigational treatment)
PET-defined response rates
To determine the effect of single agent tislelizumab on response (overall response rate (ORR), partial response (PR), complete response (CR) and Indeterminate Response (IR)) after 3 cycles of tislelizumab (PET1) and at end of initial treatment (PET2)
Measured: After 3 cycles of tislelizumab (PET1) and at the end of the initial treatment (PET2) - up to 2 years after start of treatment
Overall survival (OS) of the whole population
To determine the effect of response adapted treatment with tislelizumab on OS
Measured: From the date of registration until the date of death (any cause) or the date last seen (patients alive at time of analysis).
Progression free survival (PFS) of the whole population
To determine the effect of response adapted treatment with tislelizumab on PFS
Measured: 2 years after start of treatment
EFS in early versus late stage patients
To determine the effect of response adapted treatment with tislelizumab on EFS within early and late stage subgroups of patients
Measured: Up to 2 years after start of treatment
EFS in interim PET negative and positive patients
To determine the effect of response adapted treatment with tislelizumab on EFS in PET1 negative and positive patients
Measured: Up to 2 years after start of treatment
Quality of life (QoL) assessed using EQ-5D-5L and FACT-Lym
To assess the effect of treatment on QoL using using EQ-5D-5L and FACT-Lym at baseline and at multiple points during treatment and follow-up. These will be analysed using repeated measures including patient group.
Measured: From baseline until 2 years after start of treatment
Time to treatment failure
To assess the rate of unplanned Hodgkin lymphoma therapy using Kaplan-Meier survival analysis, with plots and rates at 2 years presented.
Measured: From the date of registration until the first date of progression, death or unplanned Hodgkin lymphoma therapy (switch to other regimens or any unplanned consolidation treatment) up to 2 years after start of trial treatment.
PFS in early versus late stage patients
To determine the effect of response adapted treatment with tislelizumab on PFS within early and late stage subgroups of patients
Measured: 2 years after start of treatment
OS in early versus late stage patients
To determine the effect of response adapted treatment with tislelizumab on OS within early and late stage subgroups of patients
Measured: Up to 2 years after start of treatment
PFS in interim PET negative and positive patients
To determine the effect of response adapted treatment with tislelizumab on PFS in PET1 negative and positive patients
Measured: Up to 2 years after start of treatment
OS in interim PET negative and positive patients
To determine the effect of response adapted treatment with tislelizumab on OS in PET1 negative and positive patients
Measured: Up to 2 years after start of treatment
Frailty assessed using the Clinical Frailty Score (CFS)
To assess the effect of treatment on frailty using the Clinical Frailty Score at baseline and at multiple points during treatment and follow-up. These will be analysed using repeated measures including patient group.
Measured: From baseline until up to 2 years after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Mar 2024 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene
- Responsible party
- Sponsor
- Investigators
- Prof Graham Collins, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627115
- Sponsor's protocol ID
- UCL 143242
- Other IDs
- 2022-003677-37
- Acronym
- RATiFY
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Adapted Incorporation of Tislelizumab Into the Front-line Treatment of Older Patients With Hodgkin lYmphoma (RATiFY)
- ClinicalTrials.gov ID
- NCT05627115
- Acronym / sponsor ID
- RATiFY / UCL 143242
- Conditions
- Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- BeiGene
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the effect of tislelizumab treatment in patients with Hodgkin lymphoma. The main question it aims to answer is whether including a drug called tislelizumab in first-line treatment of Hodgkin lymphoma for patients age 60 years and older is effective and well-tolerated.
Participants will initially receive tislelizumab infusion every 21 days for 3 doses. After this a PET scan will be performed to assess the response. The subsequent treatment patients receive will depend on the following factors:
- The lymphoma stage (early stage or advanced stage)
- The presence or absence of specific high-risk features at the time of diagnosis
- How well the lymphoma responds to the initial 3 doses of tislelizumab
Detailed description
Trial patients who are deemed eligible for the trial will receive 3 cycles of tislelizumab which will be administered at a dose of 200 mg (IV) on day 1 of each 21-day cycle. Patients will then undergo a PET-CT scan (PET1). Subsequent treatment is determined by the patient's stage and response to tislelizumab (as determined by PET1).
Patients with early stage lymphoma and no high-risk features who respond very well to the initial 3 doses of tislelizumab will receive a further 2 doses of tislelizumab, followed by radiotherapy, followed by tislelizumab once every 21 days for up to 2 years.
All other patients will receive a combination of tislelizumab with chemotherapy for between 2 and 6 cycles. Each cycle will last 28 days. Tislelizumab will be given on day 1 and chemotherapy (doxorubicin (also known as Adriamycin), vinblastine and dacarbazine, or AVD) will be given on days 1 and 15, as injections or infusions into a vein. Following this some patients may require radiotherapy depending on their response to treatment.
Patients who are in complete metabolic response (CMR) at PET1 will receive 2 fewer cycles of tislelizumab and AVD therapy than those not in CMR.
A further 1 or 2 PET scans will be performed to assess how well the lymphoma has responded to the trial treatment, depending on the results of previous scans. After completing the treatment patients will then be followed-up for at least 2 years from the start of their participation in the trial.
Note: Initial patients will be recruited to a safety run in. Once 6 evaluable patients have completed 2 cycles of tislelizumab and AVD after PET1 the independent data monitoring committee (IDMC) will review the data, and if considered tolerable, recruitment will continue to the full sample size (80 patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab Response-Adapted Treatment | Experimental | Drug: Tislelizumab, AVD, RadiotherapyAll patients will receive 3 cycles of tislelizumab 200 mg (IV) every 21 days. They will then undergo a PET-CT scan (PET1). Subsequent treatment with further tislelizumab, radiotherapy, and between 2-6 cycles of chemotherapy (Doxorubicin, Vinblastine, and Dacarbazine - AVD) is determined by the patient's stage and response at PET1. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Newly diagnosed untreated classic Hodgkin lymphoma (Stage I-IV)
- Age 60 years or over
- In the view of the investigator, fit for combination chemotherapy (includes those who would require planned dose reduction although no lower than 50% doxorubicin)
- Written informed consent
- Measurable disease on contrast enhanced CT as defined by Cheson et al., 2014 1 (Nodal lesion of longest diameter 1.5 cm or extranodal lesion of longest diameter 1.0 cm).
Key exclusion criteria (26 listed)
- Nodular lymphocyte predominant Hodgkin lymphoma
- History of autoimmune disorders (with the exception of hypothyroidism, type 1 diabetes, vitiligo, alopecia)
- History of solid organ transplant
- Grade 2 or higher peripheral neuropathy
- Presentation with disease causing symptomatic compression of vital structures (e.g. stridor due to tracheal compression). Other cases of radiological compression of vital structures require discussion with TMG prior to registration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab, AVD, RadiotherapyAlso: Response-adapted incorporation of tislelizumabGROUP A: Early stage disease without adverse features in CMR: 2 further cycles tislelizumab then radiotherapy then 200mg IV tislelizumab once every 3 weeks until a maximum of 2 years total treatment. PET-CT (PET2) 12 weeks after radiotherapy. GROUP B: Early stage disease with adverse features in CMR: 2 cycles of AVD plus tislelizumab then radiotherapy. PET-CT (PET2) 12 weeks after the completion of radiotherapy. GROUP C: All early stage disease not in CMR: 4 cycles of AVD plus tislelizumab then PET-CT and radiotherapy. PET-CT 12 (PET2) weeks after radiotherapy. GROUP D: Advanced stage disease in CMR: 4 cycles of AVD plus tislelizumab then radiotherapy at investigator's discretion. PET-CT (PET2) 12 weeks after radiotherapy. GROUP E: Advanced stage disease not in CMR: 6 cycles of AVD plus tislelizumab then PET-CT then radiotherapy at investigator's discretion. PET-CT (PET2) 12 weeks after radiotherapy. | Drug | Tislelizumab Response-Adapted Treatment |
Primary outcome
Two-year event-free survival (EFS)
Time frame: 2 years after start of treatment
To determine the effect of tislelizumab on 2 year EFS using a response-adapted approach to treatment in the front-line treatment of older patients with Hodgkin lymphoma
13 secondary outcomes
The number / percentage of patients with the worst grade of each adverse event
Time frame: From signing of informed consent until 30 calendar days post last IMP or post last investigational treatment administration (or after this date if the site investigator feels the event is related to an IMP and/or investigational treatment)
PET-defined response rates
Time frame: After 3 cycles of tislelizumab (PET1) and at the end of the initial treatment (PET2) - up to 2 years after start of treatment
Overall survival (OS) of the whole population
Time frame: From the date of registration until the date of death (any cause) or the date last seen (patients alive at time of analysis).
Progression free survival (PFS) of the whole population
Time frame: 2 years after start of treatment
EFS in early versus late stage patients
Time frame: Up to 2 years after start of treatment
EFS in interim PET negative and positive patients
Time frame: Up to 2 years after start of treatment
Quality of life (QoL) assessed using EQ-5D-5L and FACT-Lym
Time frame: From baseline until 2 years after start of treatment
Time to treatment failure
Time frame: From the date of registration until the first date of progression, death or unplanned Hodgkin lymphoma therapy (switch to other regimens or any unplanned consolidation treatment) up to 2 years after start of trial treatment.
PFS in early versus late stage patients
Time frame: 2 years after start of treatment
OS in early versus late stage patients
Time frame: Up to 2 years after start of treatment
PFS in interim PET negative and positive patients
Time frame: Up to 2 years after start of treatment
OS in interim PET negative and positive patients
Time frame: Up to 2 years after start of treatment
Frailty assessed using the Clinical Frailty Score (CFS)
Time frame: From baseline until up to 2 years after start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- CR UK \& UCL Cancer Trials CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof Graham Collins principal investigator
Oxford University Hospitals NHS Trust
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, AVD, Radiotherapy in people with Hodgkin Lymphoma, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RATiFY Trial Coordinator (+44 (0)2076799860, ctc.ratify@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year event-free survival (EFS) (time frame: 2 years after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.