A Multicentre, Parallel Arm, Open-label Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL) (COALITION)

  • STATUS
    Recruiting
  • End date
    Jul 6, 2025
  • participants needed
    80
  • sponsor
    Peter MacCallum Cancer Centre, Australia
Updated on 6 May 2022

Summary

This is an open label, multi-centre, phase Ib/II, parallel arm study evaluating the safety and tolerability of glofitamab in addition to backbone chemotherapy consisting of R-CHOP or polatuzumab vedotin-RCHP for younger patients with higher-risk Diffuse Large B-cell Lymphoma or High Grade B-Cell Lymphoma.

Details
Condition Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
Treatment Rituximab, cyclophosphamide, vincristine, doxorubicin, Prednisolone, Polatuzumab Vedotin, Glofitamab
Clinical Study IdentifierNCT04914741
SponsorPeter MacCallum Cancer Centre, Australia
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥18yo and ≤65yo at the time of signing consent
Have a histologically confirmed diagnosis of one of the following, according to the 2016 WHO classification
DLBCL, NOS or DLBCL arising as a result of transformation of an indolent lymphoma
HGBL, NOS
HGBL with rearrangements of MYC and BCL2 and/or BCL6
For DLBCL, and HGBL, NOS meets one of the following risk criteria
NCCN-IPI of ≥4 or IPI ≥3 (appendix 1 and 3)
Considered fit for 6 cycles of full dose R-CHOP chemotherapy, as per the Investigator
ECOG performance status (appendix 5) of
0-2 inclusive or 3 if directly attributable to lymphoma for patients entering the trial prior to cycle 1 of R-CHOP
0-1 inclusive for patients entering the trial at cycle 2
Patients must be treatment-naïve or have received a maximum of one cycle of full-dose
Able to provide an archival pre-treatment biopsy
R-CHOP chemotherapy (with or without a steroid pre-phase)
Have measurable disease on a pre-chemotherapy PET/CT, defined as at least one bi-dimensionally measurable nodal lesion of >1.5cm in longest dimension, or at least one bi-dimensionally measurable extranodal lesion of >1.0cm in longest dimension
Adequate haematological function
Life expectancy (in the opinion of the Investigator) of ≥ 18 weeks
Adequate renal function
Adequate hepatic function
Negative serologic or PCR test results for active acute or chronic HBV infection
Negative test results for HCV and HIV
Non-haematological AEs from prior anti-cancer therapy must have resolved to Grade ≤1 (with the exception of alopecia and inclusion criteria 10-12)

Exclusion Criteria

Inability to comply with protocol mandated hospitalisations and restrictions
Prior systemic treatment of an underlying indolent lymphoma with an anthracycline-containing regimen
Richter's syndrome
Patients with known CNS involvement by lymphoma
With the exception of rituximab, any prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune/cytokines, and monoclonal antibodies within 4 weeks or five half-lives of the drug, whichever is shorter, before the first dose of study drug
With the exception of CHOP used as a first cycle of lymphoma treatment, any chemotherapeutic agent, or treatment with any other investigational agent within 4 weeks prior to study treatment
Prior solid organ transplantation
Prior autologous or allogeneic stem cell transplantation
A history of treatment-emergent immune related AEs associated with prior immunotherapeutic agents
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Note: patients with a history of stroke who have not experienced a stroke or transient ischaemic attack in the past 2 years are allowed
Note: patients with a history of epilepsy who have not experienced a seizure in the past 2 years are allowed, so long as continuation of any ongoing established pharmacologic treatment is not contraindicated
Past history of confirmed progressive multifocal leukoencephalopathy
Past history of chronic active EBV or HLH
Major surgery or significant traumatic injury <28 days prior to study treatment or anticipation of the need for major surgery during study treatment
Significant cardiovascular disease, defined as
A left ventricular ejection fraction (as determined by nuclear gated blood pool scan or echocardiogram) <50%
Myocardial infarction or unstable angina within the past 6 months
Unstable arrhythmia
Any other cardiac illness that, in the opinion of the Investigator or CPI, makes the patient unsuitable for anthracycline containing therapy
Current grade >1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
Significant pulmonary disease, including but not limited to clinically significant
Known clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
obstructive pulmonary disease or history of bronchospasm
Administration of a live, attenuated vaccine within 4 weeks before study treatment note: influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccine at any time during the study treatment period
History of other active malignancy within 5 years prior to registration, with the exception of
FL or MZL, previously untreated, or treated with no more than one line of therapy which must not have contained an anthracycline
Basal or squamous cell carcinoma or Stage 1 melanoma of the skin or in situ carcinoma of the cervix
Note: Patients with latent tuberculosis are excluded
Prior malignancy treated with a curative intent that has remained in remission without treatment for ≥2 years prior to registration
Patients with known active bacterial, viral, fungal, mycobacterial, parasitic, or
Major contraindication to any of the individual components of the chemotherapy backbone (R, C, H, O, Polatuzumab vedotin, prednisolone)
other infection (excluding fungal infections of the nail beds) at registration
Patients who are pregnant or breastfeeding
Other protocol-defined inclusion and exclusion criteria may apply
Other significant life-threatening illness or medical condition which, in the
Investigator's opinion, could compromise the patient's safety, interfere with
absorption or metabolism of study drug, affect compliance with the protocol or
interpretation of results, or put the study outcomes at undue risk
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