NCT04479267

Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma

Active, enrolled Phase 2 Last updated 29 September 2025

What this trial tests

Phase 2 trial testing Prednisone in Diffuse Large B-Cell Lymphoma in 8 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 August 2020

Primary endpoint
19 June 2025

19 July 2026

Quick facts

Lead sponsor	Barbara Ann Karmanos Cancer Institute
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	21 August 2020
Primary completion	19 June 2025
Estimated completion	19 July 2026
Sites	1 location across United States

Drugs / interventions tested

• Prednisone (prednisone) — full drug profile →
• Prednisolone — full drug profile →
• Methylprednisolone (methylprednisolone) — full drug profile →
• Rituximab
• Polatuzumab Vedotin
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Doxorubicin Hydrochloride — full drug profile →

Conditions studied

• Diffuse Large B-Cell Lymphoma — all drugs for Diffuse Large B-Cell Lymphoma →
• High Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 Rearrangements — all drugs for High Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 Rearrangements →
• High Grade B-Cell Lymphoma w/MYC, BCL2 & BCL6 Rearrangements — all drugs for High Grade B-Cell Lymphoma w/MYC, BCL2 & BCL6 Rearrangements →
• Double Expressor Lymphoma — all drugs for Double Expressor Lymphoma →

Sponsor

Barbara Ann Karmanos Cancer Institute

Who can join

18 and older, any sex, with Diffuse Large B-Cell Lymphoma or High Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 Rearrangements. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well polatuzumab vedotin and combination chemotherapy work in treating patients with previously untreated double, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell Lymphoma. Polatuzumab vedotin is a monoclonal antibody that works by binding with cancer cells and releasing another chemotherapy drug, called monomethyl auristatin E, into the cell causing the cancer cells to die or stop growing. Chemotherapy drugs, such as rituximab, cyclophosphamide, doxorubicin, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving polatuzumab vedotin with combination chemotherapy may work better in treating patients with double or triple hit lymphoma compared to combination chemotherapy alone.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibody-Drug Conjugates for Cancer Therapy.
   Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764
2. Antibody-drug conjugates for the treatment of lymphoma: clinical advances and latest progress.
   Chu Y, Zhou X, Wang X. · · 2021 · cited 48× · PMID 34090506 · DOI 10.1186/s13045-021-01097-z
3. Altered pathways and targeted therapy in double hit lymphoma.
   Zhuang Y, Che J, Wu M, Guo Y, et al · · 2022 · cited 26× · PMID 35303910 · DOI 10.1186/s13045-022-01249-9
4. Monoclonal Antibodies in the Treatment of Diffuse Large B-Cell Lymphoma: Moving beyond Rituximab.
   Papageorgiou SG, Thomopoulos TP, Liaskas A, Vassilakopoulos TP. · · 2022 · cited 19× · PMID 35454825 · DOI 10.3390/cancers14081917
5. Advancements in antibody-drug conjugates as cancer therapeutics.
   Fong JY, Phuna Z, Chong DY, Heryanto CM, et al · · 2025 · cited 11× · PMID 40814440 · DOI 10.1016/j.jncc.2025.01.007
6. Changing Trends in B-Cell Non-Hodgkin Lymphoma Treatment: The Role of Novel Monoclonal Antibodies in Clinical Practice.
   Tavarozzi R, Zacchi G, Pietrasanta D, Catania G, et al · · 2023 · cited 7× · PMID 38001657 · DOI 10.3390/cancers15225397
7. Redefining Precision Management of r/r Large B-Cell Lymphoma: Novel Antibodies Take on CART and BMT in the Quest for Future Treatment Strategies.
   Dada R. · · 2023 · cited 7× · PMID 37508523 · DOI 10.3390/cells12141858
8. Novel biologic therapies in relapsed or refractory diffuse large B cell lymphoma: CAR-T is not the only answer.
   Paillassa J, Safa F. · · 2022 · cited 1× · PMID 35024331 · DOI 10.1016/j.lrr.2021.100282