Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000586314p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
4/03/2026
Date registered
Help: Date registered
11/05/2026
Date last updated
Help: Date last updated
11/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
11/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
ALLG NHL44: A Phase 2, Multicenter, Single-Arm Study to Evaluate Polatuzumab vedotin-Rituximab with/without Radiotherapy as a Bridging Therapy in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Prior to CD19 CAR-T Cell Therapy
Scientific title
An ALLG Phase 2, Multicenter, Single-Arm Study to Evaluate Polatuzumab vedotin-Rituximab with/without Radiotherapy as a Bridging Therapy in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Prior to CD19 CAR-T Cell Therapy
Additional trial identifiers [1] 316579 0
NHL44
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Diffuse Large B-cell Lymphoma 340755 0
Condition category
Condition code
Cancer 336936 336936 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will receive bridging therapy prior to Tisa-cell CAR-T cell treatment with:
• Polatuzumab vedotin (1.8mg/kg) administered intravenous (IV) on Day 1 before Rituximab administration.
• Rituximab (375mg/m^2) administered IV on Day 1.
• Both medicines will be administered 3 weeks prior to Tisa-cell CAR-T cell treatment. A second dose of both medicines may be administered on Day 21 at physician's discretion. 2 doses is the maximum number in bridging therapy.
• Radiotherapy may be added at physician's discretion from Day 1 of bridging therapy and completed 7-10 days before chemotherapy lymphodepletion of Tisa-cell CAR-T cell treatment.

All treatment will be administered by the study team (i.e., registered nurse, the lead physician, physicians listed on the trial to assist the lead physician). Drug accountability will be performed by the administering institutions to assess compliance through pharmacy dispensing logs, dose administration records, and verifying patient diaries.
Intervention code [1] 333371 0
Treatment: Drugs
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 344610 0
Complete Remission (CR) at 3 months
Timepoint [1] 344610 0
3 months after Chimeric Antigen Receptor T cell therapy (CAR-T).
Secondary outcome [1] 458590 0
Evaluate response to bridging therapy with Polatuzumab vedotin + Rituximab (PV-R) with or without radiotherapy (+/- RT).
Timepoint [1] 458590 0
End of treatment, 28 days from intervention treatment administration.
Secondary outcome [2] 458591 0
Cytoreduction in tumour volume
Timepoint [2] 458591 0
At screen and 1, 3, 6, 9, 12 and 24 months after CAR-T.
Secondary outcome [3] 458592 0
Complete Remission (CR) at 6 months
Timepoint [3] 458592 0
6 months after Chimeric Antigen Receptor T cell therapy (CAR-T)
Secondary outcome [4] 458597 0
Overall response rate (ORR)
Timepoint [4] 458597 0
At screening and 1, 3, 6, 9, 12 and 24 months after CAR-T.
Secondary outcome [5] 458598 0
Duration of response
Timepoint [5] 458598 0
At screening and 1, 3, 6, 9, 12 and 24 months after CAR-T.
Secondary outcome [6] 458599 0
Progression Free survival
Timepoint [6] 458599 0
At screening, 1 and 2 years post CAR-T treatment
Secondary outcome [7] 458601 0
Overall survival (OS)
Timepoint [7] 458601 0
1 and 2 years post CAR-T.
Secondary outcome [8] 458603 0
Quality of life - cancer treatment.
Timepoint [8] 458603 0
Baseline, start of bridging treatment, end of bridging treatment, CAR-T administration; 1, 3, 6, 9, 12, and 24 months post CAR-T.
Secondary outcome [9] 459152 0
Quality of life - general
Timepoint [9] 459152 0
Baseline, start of bridging treatment, end of bridging treatment, CAR-T administration; 1, 3, 6, 9, 12, and 24 months post CAR-T.

Eligibility
Key inclusion criteria
All of the following criteria must be satisfied for enrolment in the study.

1. Aged greater or equal to18 years at the time of signing the informed consent form.
2. Histologically confirmed Diffuse Large B Cell Lymphoma (DLBCL) (including transformed follicular lymphoma, transformed marginal zone lymphoma, or high-grade B-cell lymphoma with specified rearrangements of myc and bcl-2).
3. Relapsed or refractory disease after two or more prior lines of systemic therapy.
4. Planned treatment with commercial Tisa-cel, and is scheduled for leukapheresis (trial registration will require patient to have had leukapheresis performed) .
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at Screening
6. Adequate bone marrow function defined as:
a. Absolute neutrophil count (ANC) greater or equal to1.0×10^9/L.
b. Platelet count greater or equal to 75×10^9/L (or greater or equal to 50×10^9/L in the presence of bone marrow involvement).
c. Hemoglobin greater or equal to 8.0 g/dL (may be maintained by transfusion).
7. Adequate organ function defined as:
a. Total bilirubin level less or equal to 2× upper limit of normal (ULN) (unless due to Gilbert's syndrome or lymphoma involvement).
b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less or equal to 5× ULN (or less or equal to 5× ULN if due to hepatic involvement of disease).
c. Creatinine clearance greater or equal to 40 mL/min, by estimated Glomerular Filtration Rate (eGFR) of Cockcroft-Gault formula.
d. Left ventricular ejection fraction greater or equal to40% determined by Echocardiogram or MUGA and no clinically significant abnormal electrocardiogram (ECG) findings.
e. Baseline oxygen saturation greater than 91% on room air.
8. At least 1 measurable lesion according to the Lugano Response Criteria for Malignant Lymphoma.
9. Toxicities due to prior therapy must be stable and recovered to Grade less or equal to 1 or baseline (except for clinically nonsignificant toxicities such as alopecia).
10. Females of childbearing potential must use an effective method of contraception or practice absolute abstinence for 4 weeks prior to therapy, during treatment and at least 6 months after treatment discontinuation.
11. Male patients must use contraception measures 1 week prior to commenced of study drug, during treatment with study drug and at least 6 months after discontinuation of treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Presence of any of the following criteria will exclude the subject from enrolment in the study.

1. Patients with primary refractory Diffuse Large B Cell Lymphoma (DLBCL).
2. Not eligible for Standard-of-care Tisa-cel therapy
3. Any contraindications to polatuzumab vedotin.
4. Known history of severe allergic or anaphylactic reactions to any component of polatuzumab vedotin, Rituximab, lymphodepletion chemotherapy (cyclophosphamide or fludarabine), or prior intolerance to the planned radiotherapy
5. Known active bacterial, viral, fungal, mycobacterial, or other infection History of Human Immunodeficiency Virus (HIV) infection or acute or chronic active hepatitis B or C infection. Subjects with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing.
6. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g.: cervical, bladder, breast) unless disease free for at least 3 years or considered to be at low risk of progression in the subsequent 5 years.
7. Prior CD19-targeted antibody unless lymphoma biopsy is shown to express CD19 at the time of screening.
8. History or presence of a clinically significant central nervous system (CNS) disorder, such as cerebrovascularischemia/hemorrhage, dementia, or any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema with confirmed structural defects by appropriate imaging.
9. Patients with seizure disorders requiring active anticonvulsive medication. Note: Prior or active CNS involvement by lymphoma is not an exclusion criterion, unless uncontrolled
10. History of stroke or transient ischemic attack within 12 months before screening
11. History of unstable angina, myocardial infarction, congestive heart failure, New York Heart Association (NYHA) Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 12 months of screening.
12. Active autoimmune disease requiring immunosuppression within 2 years prior to screening.
13. Rapidly progressive lymphoma kinetics – patient likely to have uncontrolled/rapidly progressing disease for the duration of manufacturing.
14. Live vaccine of less or equal to 6 weeks before planned start of lymphodepletion therapy
15. Active, uncontrolled graft-versus-host disease grade 2 or above, or with ongoing need for Graft vs Host Disease (GVHD) therapy.
16. Pregnant or breastfeeding females, or subjects (male or female) of childbearing potential who are unwilling to use a highly effective method of contraception for the duration of the study and for at least 12 months after the last dose of study drug.
17. Concurrent treatment with another CD19-targeting investigational drug or participation in another lymphoma drug or regime or therapeutic clinical study within 30 days or 5 half-lives of the drug (s) (whichever is longer) prior to commencement of bridging therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
28/02/2028
Actual
Date of last data collection
Anticipated
29/03/2030
Actual
Sample size
Target
47
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment outside Australia
Country [1] 27873 0
Korea, Democratic People's Republic Of
State/province [1] 27873 0
Country [2] 27874 0
Hong Kong
State/province [2] 27874 0
Country [3] 27875 0
Taiwan, Province Of China
State/province [3] 27875 0

Funding & Sponsors
Funding source category [1] 321197 0
Other Collaborative groups
Name [1] 321197 0
Australasian Leukaemia and Lymphoma Group
Country [1] 321197 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Country
Australia
Secondary sponsor category [1] 323900 0
None
Name [1] 323900 0
Address [1] 323900 0
Country [1] 323900 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 319727 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 319727 0
Ethics committee country [1] 319727 0
Australia
Date submitted for ethics approval [1] 319727 0
15/06/2026
Approval date [1] 319727 0
Ethics approval number [1] 319727 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148198 0
Prof Joy Ho
Address 148198 0
Royal Prince Alfred Hospital. Missenden Road. Sydney, New South Wales, 2050
Country 148198 0
Australia
Phone 148198 0
+61 2 95158031
Fax 148198 0
Email 148198 0
[email protected]
Contact person for public queries
Name 148199 0
Delaine Smith
Address 148199 0
ALLG. 35 Elizabeth St. Richmond, VIC 3121
Country 148199 0
Australia
Phone 148199 0
+61 03 83739701
Fax 148199 0
Email 148199 0
[email protected]
Contact person for scientific queries
Name 148200 0
Delaine Smith
Address 148200 0
ALLG. 35 Elizabeth St. Richmond, VIC 3121
Country 148200 0
Australia
Phone 148200 0
+61 03 83739701
Fax 148200 0
Email 148200 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
3 months after publication

To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data sharing request system: Health Data Australia catalogue (e.g. https://researchdata.edu.au/health/)

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected] Access can be requested via the Health Data Austra... [More Details]


Results publications and other study-related documents

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Documents added automatically
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