Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
03/12/2018
Funder:
Bristol-Myers Squibb
Sponsor:
UCL
Chief Investigator:
Dr Graham Collins
Recruitment target:
120
EudraCT number:
2017-002544-32
Contact details:
ctc.animate@ucl.ac.uk
Lay summary:
ANIMATE
A phase II study of nivolumab monotherapy in patients with relapsed/refractory Hodgkin lymphoma, fit for autologous stem cell transplant, who fail to reach complete metabolic remission after first or second line salvage therapy
Description
Design: Single-arm, open label, multicentre phase II trial.
Treatment:

Patients can be consented and registered at any time before, during or within 14 days after completing two cycles of first line or second line salvage therapy (4 cycles if being treated with brentuximab vedotin).

A PET-CT scan will be performed under trial conditions following 2 cycles of first line or second salvage (4 cycles if being treated with brentuximab vedotin) to determine eligibility for trial treatment.

  • Patients who are PET-negative (Deauville 1-3) will not be eligible for trial treatment.They will enter follow up for the purpose of the trial, and any further treatment will be at their treating clinician’s discretion.

  • Patients who are PET-positive (Deauville 4-5) after first line salvage chemotherapy will receive 4 x 14-day cycles of nivolumab.

    A further PET-CT scan will then be performed:

  • Patients who are PET negative (Deauville 1-3) will stop trial treatment and enter followup.

Patients who are PET positive (Deauville 4-5) will have a further 4  x 14-day cycles of nivolumab, unless there is evidence of progressive disease
Key inclusion/exclusion criteria:

Inclusion criteria for registration

  • Age 16 or over

  • Primary refractory classical Hodgkin lymphoma or classical Hodgkin lymphoma in firstrelapse

  • About to receive, receiving or within 14 days of first 2 cycles of first or second line salvage therapy (4 cycles if receiving treatment with brentuximab vedotin)

  • Fit for autologous stem cell transplantation

  • Written informed consent

  • Willing to comply with the contraceptive requirements of the trial

    Exclusion criteria for registration

  • Nodular lymphocyte predominant Hodgkin lymphoma

  • Women who are pregnant or breastfeeding

  • History of colitis, inflammatory bowel disease or pneumonitis

  • Patients with autoimmune disorders excluding patients with vitiligo, diabetes mellitustype 1, hypo- and hyperthyroidism not requiring immunosuppressive therapy

  • Known active hepatitis B or C infection

  • Known HIV infection

  • History of allergy (including severe/life threatening skin reaction) to monoclonalantibodies, anaphylaxis or uncontrolled allergy

  • Major surgery within 4 weeks prior to registration

  • Myocardial infarction, unstable angina, coronary artery bypass graft, cerebrovascular accident or transient ischaemic attack within the past 6 months

  • Non-haematological malignancy within the past 3 years (some exceptions apply – see trial protocol)

    Inclusion criteria – trial treatment

  • Has received 2 cycles of first line or second line salvage chemotherapy (4 cycles ifbeing treated with brentuximab vedotin)

  • PET positive (Deauville score 4 or 5) after 2 cycles of first or second line salvage chemotherapy (4 cycles if being treated with brentuximab vedotin)

  • Fit for further salvage chemotherapy

  • ECOG performance status 0-1

  • Creatinine clearance >30ml/min calculated by Cockroft-Gault formula

  • Bilirubin

  • Adequate bone marrow function (Hb >80g/l, Platelets >50 x 109/l,neutrophils >1.0 x 109/l

    Exclusion criteria for trial treatment

  • Deauville score 1-3 after 2 cycles of first or second line salvage chemotherapy (4 cycles if being treated with brentuximab vedotin)

  • Positive serology for hepatitis B or C (some exceptions apply – see trial protocol)

  • Active infection requiring systemic therapy

  • Ongoing immunosuppressive therapy, apart from inhaled, intranasal, topical corticosteroids or systemic corticosteroids at low doses (≤10mg prednisolone or equivalent per day).

  • Chemo-or radiotherapy or corticosteroids at a dose of more than 10mg/day prednisolone or equivalent within 14 days prior to response PET-CT. NOTE: corticosteroids can be used AFTER a positive PET-CT scan for symptomatic disease but must be weaned to a dose of prednisolone ≤10mg/day or less (or equivalent) at least 7 days prior to starting nivolumab.

  • Treatment with any investigational agent within 28 days prior to planned start of nivolumab

  • Ongoing grade 2-4 non-haematological toxicities related to prior Hodgkin lymphoma treatments, with the exception of alopecia and grade 2 fatigue

  • Pregnant or breastfeeding women

Duration of recruitment: 3 years.
Aim
To assess the efficacy of nivolumab as a second or third line salvage therapy in relapsed/refractory classical Hodgkin lymphoma patients, particularly as a bridge to stem cell transplant.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
NameTypeVersionCurrent versRelease dateDownload
1 ANIMATE Registration Case Report FormCRF2.0 Current 17/12/2019
10 ANIMATE Disease Progression FormCRF1.0 Current 22/11/2018
11 ANIMATE Death FormCRF1.0 Current 22/11/2018
12 ANIMATE Lost to follow up FormCRF1.0 Current 22/11/2018
13 ANIMATE Transfer of Care FormCRF1.0 Current 22/11/2018
14 ANIMATE New Treatment FormCRF1.0 Current 22/11/2018
15 ANIMATE Adverse Event FormCRF1.0 Current 22/11/2018
16 ANIMATE Normal Range Form CRF2.0 Current 10/02/2020
2 ANIMATE Post-Salvage Case Report FormCRF2.0 Current 17/12/2019
3 ANIMATE Treatment FormCRF2.0 Current 17/12/2019
4 ANIMATE Treatment Summary FormCRF1.0 Current 22/11/2018
5 ANIMATE Follow Up Form - nivolumabCRF2.0 Current 17/12/2019
6 ANIMATE Annual Follow Up Form NIVOLUMABCRF1.0 Current 22/11/2018
7 ANIMATE Follow Up Form - No Trial TreatmentCRF1.0 Current 22/11/2018
8 ANIMATE Transplant FormCRF1.0 Current 22/11/2018
9 ANIMATE Post-Allogeneic Transplant FormCRF1.0 Current 22/11/2018
ANIMATE SAE Report Form v2.0 04.01.19SAEform2.0 Current 04/01/2019
Contact Us
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