KITE-363: A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma
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PETReA
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ZUMA-22 - A Phase 3 Randomised, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma
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REFRACT - Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy
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MoTD
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RESPECT
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OptiMATE
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Ascelus-H
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Multiple stages
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CLL
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First line
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Multiple stages
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DLBCL
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First line
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Relapsed / refractory
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FL
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First line
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Relapsed / refractory
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NHL
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Multiple stages
2
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Primary CNS lymphoma
Count1
Treatment stage
First line
1
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Waldenstrom's
Count1
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Multiple stages
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Population
Description
ECOG
Evelina PI
KCH PI
GSTT PI
PRUH PI
QEH PI
UHL PI
Trial summary
Key Eligibility Criteria
Summary
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Summary
For adults awaiting a planned allo-SCT
Phase 2 trial: Thymoglobulin vs. Calcineurin inhibitor or cyclophosphamide as GvHD prophylaxis
Not specified
p.krishnamurthy@nhs.net
Stem cell transplantation from a matched sibling or unrelated donor (allo-SCT) is the only curative therapy for many children and adults with blood cancer. However allo-SCT remains associated with a number of life-threatening side effects, the most serious of which is ‘graftversus-host disease’ (GvHD). This complication occurs when donor immune cells (the ‘graft’) see the patient’s healthy skin, gut or liver (the ‘host’) as foreign and attacks them. Patients currently receive a combination of d
Availability of suitably matched unrelated donor (9/10 or 10/10)
For adults undergoing HSCT
Phase 3 randomised trial: Rezafungin vs standard treatment to prevent IFI
Not specified
varun.mehra@nhs.net
The ReSPECT trial is a global, randomized, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic BMT. Rezafungin, dosed once-weekly, will be compared to a daily regimen containing multiple drugs including fluconazole or posaconazole, and trimethoprim-sulfamethoxazole, also known as Bactrim, for 90 days, at which time fungal-free survi
≥18 years of age
Adult patients with untreated CLL or Small Lymphocytic Lymphoma
Phase 3 randomised study: of sonrotoclax & zanubrutinib vs venetoclax & obinutuzumab
0-2
piers.patten1@nhs.net
A Phase 3, Open-label, Randomized Study of BGB-11417 plus Zanubrutinib Compared with Venetoclax plus Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma
Treatment-naïve (TN) adult patient ≥ 18 years with confirmed diagnosis of CLL that meets the iwCLL criteria (Hallek et al 2018).
For adults with Richter's syndrome or CLL
Phase 2 randomised study: acalabrutinib + CHOP-R vs CHOP-R
0-3
piers.patten1@nhs.net
The STELLAR trial will assess the effect of acalabrutinib taken in combination with CHOP-R compared to taking CHOP-R alone in patients with newly diagnosed Richter’s Syndrome (RS). It will also be a platform to test other new drugs that show potential for treating RS. Chronic lymphocytic Leukaemia (CLL) is the most common blood cancer in adults, usually in their 70s or older. In a few patients, CLL can transform from a slow-growing cancer into an aggressive lymphoma called Richter’s Syndrome. RS
Inclusion criteria:
For adults with stable CLL, Haemochromatosis, irron-deficient anaemia, MDS, MGUS, Smouldering myeloma, SCD, or Waldenstrom’s macroglobulinemia
Digital follow-up pathway monitoring long-term stable blood conditions
None
reubenbenjamin@nhs.net
This study has 5 arms: Arm 1 - Patient and carer co-design,collecting qualitative data on patient satisfaction and empowerment on follow-up pathways,via focus groups and individual interviews Arm 2 – Healthcare professionals co-design and feedback,collecting qualitative data on Healthcare professionals views and feedback of the digital follow-up pathways,via focus groups and interviews Arm 3 – Key Opinion Leader (KOL) interviews,investigating issues of implementation,scalability,and commercialis
Inclusion for Arm 1:
For adults awaiting a planned allo-SCT
Phase 2 trial: Thymoglobulin vs. Calcineurin inhibitor or cyclophosphamide as GvHD prophylaxis
Not specified
p.krishnamurthy@nhs.net
Stem cell transplantation from a matched sibling or unrelated donor (allo-SCT) is the only curative therapy for many children and adults with blood cancer. However allo-SCT remains associated with a number of life-threatening side effects, the most serious of which is ‘graftversus-host disease’ (GvHD). This complication occurs when donor immune cells (the ‘graft’) see the patient’s healthy skin, gut or liver (the ‘host’) as foreign and attacks them. Patients currently receive a combination of d
Availability of suitably matched unrelated donor (9/10 or 10/10)
For adults undergoing HSCT
Phase 3 randomised trial: Rezafungin vs standard treatment to prevent IFI
Not specified
varun.mehra@nhs.net
The ReSPECT trial is a global, randomized, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic BMT. Rezafungin, dosed once-weekly, will be compared to a daily regimen containing multiple drugs including fluconazole or posaconazole, and trimethoprim-sulfamethoxazole, also known as Bactrim, for 90 days, at which time fungal-free survi
≥18 years of age
For adults with newly diagnosed DLBCL
Phase 2 randomised study: molecular guided therapy with Acalabrutinib
0-3
murugaiyan.thanigaikumar@nhs.net
murugaiyan.thanigaikumar@nhs.net
Trial Title
A randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma with Acalabrutinib (REMoDL-A).
Trial Description
Retrospective molecular profiling of untreated DLBCL samples has recognised 4 distinct sub-classifications of this disease (ABC-DLBCL, GCB- DLBCL, unclassified DLBCL and MHG DLBCL), each with unique biological features and clinical outcomes when treated with CHOP or R-CHOP chemotherapy. Dysregulation of B-cell receptors (BCR) signalling path
Inclusion criteria:
For adults with r/r B-cell lymphoma
Phase 1 study: KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell
None
robinsanderson1@nhs.net
A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma
Eligible study participants who have received IP administration with either KITE-363 or KITE-753 will transition to a separate Long-term Follow-up study (Study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.
Inclusion criteria:
For adults with Follicular Lymphoma requiring 1st line therapy
Phase 3 evaluation of PET-guided, Response-Adapted Rx
0-2
Suzanne.Arulogun@gstt.nhs.uk.
Follicular lymphoma (FL) is a slowly growing cancer of the lymph glands. It often responds well to treatment but has a tendency to come back again (relapse) and therefore needs to be treated more than once. Initial treatment is usually with a 6-month course chemotherapy combined with an antibody drug called rituximab (R+chemo). Most patients who respond to R+chemo are offered further (maintenance) therapy with rituximab alone over a period of 2 years with the aim of delaying relapse. However, th
Inclusion criteria:
Adults with relapsed/refractory Follicular Lymphoma
Phase 3 randomised study: Axicabtagene Ciloleucel vs standard of care
0-1
piers.patten1@nhs.net
Primary Objective:
To determine if axicabtagene ciloleucel is superior to standard of care therapy (SOC), as measured by progression-free survival (PFS) per a blinded independent radiologic review committee (hereafter referred to as central assessment) in subjects with r/r FL
Secondary Objective:
To further characterize the efficacy and safety profile and patient-reported outcomes associated with axicabtagene ciloleucel versus SOC
Exploratory Objective:
To characterize the pharmacokine
Histologically-confirmed FL (grade 1, 2, or 3a) per local diagnosis. If clinically permissible, a new biopsy is strongly recommended at screening to exclude subjects with transformed disease or those who were initially misdiagnosed. Tumor tissue must be provided for retrospective central pathology review. If an archival specimen is not available, a new biopsy is required prior to randomization.
Adults with relapsed / refractory Follicular Lymphoma
Phase 2 study: epcoritamab & lenalidomide vs investigator's choice
0-2
emil.kumar@nhs.net
A prospective, randomised, phase II platform trial for sequential evaluation of experimental treatments versus investigator choice standard therapy (ICT) for patients with relapsed or refractory follicular lymphoma (rrFL). There are three sequential treatment rounds; each has a control arm of ICT and an experimental novel treatment arm. Patients in Round 1 (R1) will be randomised using a 1:1 allocation ratio to receive either ICT or epcoritamab + lenalidomide (experimental treatment). Patients i
Biopsy proven relapsed or refractory CD20 positive,grade 1-3a follicular lymphoma (biopsy within 3 months of trial entry)
For adults awaiting a planned allo-SCT
Phase 2 trial: Thymoglobulin vs. Calcineurin inhibitor or cyclophosphamide as GvHD prophylaxis
Not specified
p.krishnamurthy@nhs.net
Stem cell transplantation from a matched sibling or unrelated donor (allo-SCT) is the only curative therapy for many children and adults with blood cancer. However allo-SCT remains associated with a number of life-threatening side effects, the most serious of which is ‘graftversus-host disease’ (GvHD). This complication occurs when donor immune cells (the ‘graft’) see the patient’s healthy skin, gut or liver (the ‘host’) as foreign and attacks them. Patients currently receive a combination of d
Availability of suitably matched unrelated donor (9/10 or 10/10)
For adults undergoing HSCT
Phase 3 randomised trial: Rezafungin vs standard treatment to prevent IFI
Not specified
varun.mehra@nhs.net
The ReSPECT trial is a global, randomized, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic BMT. Rezafungin, dosed once-weekly, will be compared to a daily regimen containing multiple drugs including fluconazole or posaconazole, and trimethoprim-sulfamethoxazole, also known as Bactrim, for 90 days, at which time fungal-free survi
≥18 years of age
Adult patients with newly diagnosed primary CNS lymphoma
Phase III randomised trial: rituximab & methotrexate vs MATRix as primary CNS lymphoma induction treatment ahead of HDT-ASCT
<65yo: any; 65-70yo: 0-2
andrea.kuhnl@nhs.net
OptiMATe is a randomised phase 3 superiority design with a primary endpoint of 2-year event-free survival. Patients will be randomised between the control arm (4 cycles of MATRix followed by HDT-ASCT) and the experimental arm. Patients in the experimental arm will receive one cycle of rituximab and high-dose methotrexate only; this less intensive initial treatment cycle aims to improve the patient's performance status and neurocognitive function and reduce early treatment-related morbidity and m
Immunocompetent patients with newly diagnosed primary diffuse large B-cell lymphoma of the central nervous system (PCNSL).
For adults with stable CLL, Haemochromatosis, irron-deficient anaemia, MDS, MGUS, Smouldering myeloma, SCD, or Waldenstrom’s macroglobulinemia
Digital follow-up pathway monitoring long-term stable blood conditions
None
reubenbenjamin@nhs.net
This study has 5 arms: Arm 1 - Patient and carer co-design,collecting qualitative data on patient satisfaction and empowerment on follow-up pathways,via focus groups and individual interviews Arm 2 – Healthcare professionals co-design and feedback,collecting qualitative data on Healthcare professionals views and feedback of the digital follow-up pathways,via focus groups and interviews Arm 3 – Key Opinion Leader (KOL) interviews,investigating issues of implementation,scalability,and commercialis