New Trials in Leukemia and Lymphoma Enrolling Now

Several clinical trials in leukemia and lymphoma have opened recently. Perhaps one of your patients could benefit from taking part?

High-risk large B-cell lymphoma. Adult patients with this type of lymphoma who have received only one cycle of rituximab plus chemotherapy are eligible for a randomized, open-label, phase 3 study assessing the CAR T-cell therapy axicabtagene ciloleucel (Yescarta) in the first-line setting vs physician's choice of standard of care therapy. The US Food and Drug Administration (FDA) approved axicabtagene ciloleucel last year for people who relapsed after, or were refractory to, first-line chemoimmunotherapy. Like all CAR T-cell treatments, this agent contains the patient's own T cells engineered to express receptors matched to the patient's tumor antigen-mutation profile.

For 3 days, one group of participants will receive daily intravenous (IV) infusions of cyclophosphamide plus fludarabine (Fludara), followed by a single IV infusion of axicabtagene ciloleucal. The other group will receive physician's choice of standard of care for up to 18 weeks. Event-free survival is the primary endpoint. Overall survival and quality of life (QoL) are secondary measures. Sites in Colorado, New York, South Dakota, Tennessee, Washington, Texas, and Australia started recruitment for 300 participants in February 2023. Sites in California and Massachusetts are also planned. More details at clinicaltrials.gov.

Chronic myelomonocytic leukemia (CMML) or myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts. Adult patients in one of these clinical situations can join an open label, randomized, National Cancer Institute phase 2 study looking at whether decitabine plus cedazuridine (ASTX727, Inqovi) works better when venetoclax (Venclexta, Venclyxto) is added.

Decitabine is a hypomethylation agent that, among other effects, may permit re-expression of silenced tumor-suppressor genes. Cedazuridine enhances the bioavailability of decitadine. Venetoclax blocks Bcl-2, a protein that prolongs the cells' survival and is found in high levels in cancer cells.

All participants will take tablets of ASTX727 for 5 days every 4 weeks until disease progression or unacceptable toxicity. People on the combination therapy will also take daily tablets of venetoclax for 2 weeks out of every 4. Sites in Kansas and Virginia opened their doors in April 2023 seeking 132 participants. Complete response is the primary outcome. Overall survival is a secondary outcome and QoL is not tracked. More details at clinicaltrials.gov.

Newly diagnosed, untreated, early stage classic Hodgkin lymphoma. Individuals aged 5 to 60 years old with this type of lymphoma are eligible for a National Cancer Institute, open-label, randomized, phase 3 trial to see whether adding immunotherapy to standard treatment (chemotherapy with or without radiation) can increase survival with fewer side effects than the usual approach. All participants will undergo two, 21-day cycles of a standard chemotherapy regimen. One group will also receive four, thrice-weekly IV infusions of brentuximab vedotin (Adcetris) and nivolumab (Opdivo). A third group will be treated with involved site radiation therapy after chemotherapy. Centers across 21 states, including Hawaii, started recruiting for the trial's 1875 participants in April 2023. The primary outcome is PFS. Overall survival and QoL are secondary endpoints. More details at clinicaltrials.gov.

Relapsed/refractory diffuse large B-cell lymphoma, grade 3b follicular lymphoma, or primary mediastinal large B-cell lymphoma. Adults facing one of these clinical scenarios can join a National Cancer Institute, open-label, phase 2 trial examining the effectiveness of the monoclonal antibodies mosunetuzumab (Lunsumio) and polatuzumab vedotin (Polivy) as "consolidation" therapy after CAR T-cell therapy. Consolidation is a short-term treatment the patient takes to enhance a previously obtained response.

All participants will receive lymphodepleting chemotherapy followed by a single IV infusion of one of three commercially approved CAR T-cell therapies: tisagenlecleucel (Kymriah), axicabtagene ciloleucel, or lisocabtagene maraleucel (Breyanzi). To test the effectiveness of consolidation therapy, outcomes will be compared among patients who receive consolidation therapy vs those who do not. One group will receive IV mosunetuzumab, a second group will receive IV polatuzumab, a third group will receive both drugs, and a fourth group will simply be observed following CAR T therapy but can move to a treatment group if their cancers progress. The Medical University of South Carolina, Charleston, began recruiting the planned 396 trial participants in June 2023. The primary outcome is PFS. Overall survival is a secondary outcome and QoL is not measured. More details at clinicaltrials.gov.

CD20+ large B-cell lymphoma. Adults aged over 75 who are newly diagnosed with this cancer and can't tolerate anthracycline therapy may wish to consider a randomized, open-label, phase 2 trial testing epcoritamab (Epkinly) with or without lenalidomide (Revlimid). Epcoritamab is a bispecific CD20-directed CD3 T-cell engager that targets both the immune system and tumor cells. It received FDA accelerated approval in May 2023 for second-line treatment of large B-cell lymphoma.

For approximately 1 year, all people in the study will receive subcutaneous injections of epcoritamab, starting with once-weekly injections that eventually taper to one every 4 weeks. One group of participants will also take daily capsules of lenalidomide for 3 out of 4 weeks. The study opened in March 2023 in Europe looking for 180 participants, and a site in Wisconsin is gearing up to start enrollment. The primary outcome measure is complete response rate. Overall survival and symptom-related QoL are secondary outcomes. More details at clinicaltrials.gov.

High-risk hematological malignancies. Adults aged 21 to 65 years with acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), MDS, chronic myelogenous leukemia (CML), myoproliferative disorder, or non-Hodgkin lymphoma may be eligible to participate in a Memorial Sloan Kettering Cancer Center, open-label, phase 2 study testing the strengths and weaknesses of its protocol for cord-blood transplant. Cord blood grafts are standard in adults with blood cancers, but every center takes a slightly different approach. All participants will receive conditioning chemotherapy followed by the cord-blood transplant. Seven Memorial Sloan Kettering sites across New Jersey and New York started recruiting 54 participants in May 2023. The primary outcome is overall survival over 1 year. QoL will not be recorded. More details at clinicaltrials.gov.

All trial information is from the National Institutes of Health US National Library of Medicine (online at clinicaltrials.gov).

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Cite this: New Trials in Leukemia and Lymphoma Enrolling Now - Medscape - Jul 18, 2023.