ONO-4685 for Lymphoma
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Ono Pharmaceutical Co. Ltd
Must not be taking: Anti-PD-1, Anti-PD-L1
Disqualifiers: CNS involvement, ATLL, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial will test a new drug called ONO-4685 in patients whose T cell Lymphoma has come back or did not respond to previous treatments. Researchers aim to see if the drug is safe, how it moves through the body, and if it helps reduce the cancer.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
Adults over 18 with relapsed or refractory T cell lymphoma, who've had at least two prior treatments and have measurable disease, can join this trial. They must not be pregnant, have a central nervous system involvement, HIV, hepatitis B or C infections, recent tuberculosis infection, severe allergies to monoclonal antibodies or corticosteroids.Inclusion Criteria
Life expectancy of at least 3 months
I have PTCL with at least one tumor that can be measured.
My diagnosis is a specific type of T-cell lymphoma.
+6 more
Exclusion Criteria
I do not have an active infection like HIV or hepatitis B/C.
I have a cancer type other than T-cell lymphoma.
I still have side effects from previous cancer treatments that haven't improved.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive ONO-4685 monotherapy to assess safety, tolerability, and preliminary efficacy
3 weeks
Weekly visits for dose escalation and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
48 weeks
Regular visits for pharmacokinetics and immunogenicity assessments
Long-term follow-up
Participants are monitored for long-term safety and antitumor activity
Up to 1 year
Participant Groups
The trial is testing ONO-4685's safety and effectiveness for patients with specific types of T cell lymphoma that haven't responded well to previous treatments. It will look at how the body processes the drug and its preliminary success in treating the cancer.
1Treatment groups
Experimental Treatment
Group I: ONO-4685 monotherapyExperimental Treatment1 Intervention
Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Oregon Health & Science UniversityPortland, OR
City of HopeDuarte, CA
Stanford Cancer InstitutePalo Alto, CA
Yale Cancer CenterNew Haven, CT
More Trial Locations
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Who Is Running the Clinical Trial?
Ono Pharmaceutical Co. LtdLead Sponsor
References
[Therapy of high-grade non-Hodgkin's lymphoma]. [2015]Complete remission can be achieved in 50 to 80% of adult patients with high-grade non-Hodgkin's lymphoma [2, 33]. The average disease-free survival is 40 to 50% at 3 years and 30 to 35% at 5 years [2, 6]. The diagnosis of non-Hodgkin's lymphoma should still be based on the histopathological and immunohistochemical evaluation of a surgical biopsy specimen. Initial staging involves radiological evaluation of tumor mass and lymph-node involvement, bone marrow biopsy, conventional laboratory investigations including LDH and beta 2-microglobulin, as well as chromosome analysis and molecular biology. These methods are also used for monitoring of patients during and after therapy. Established negative risk factors include age over 60 years, clinical stage III or IV, involvement of more than 1 extranodal site, a WHO performance status of 2 or more, and an elevation of the LDH. CHOP remains the standard chemotherapy. Aggressive regimens of the second and third generations, as well as dose-intensification have failed to prove a superior effect on overall survival [7]. Full-dose treatment on schedule can be facilitated by supportive therapy with cytokines such as G-CSF or GM-CSG. High-risk patients may have a favorable outcome after myeloablative chemotherapy and radiation followed by autologous or allogeneic bone marrow transplantation. Co-ordinated planning between conventional centers and transplant units should lead to a risk adjusted treatment of the individual patient.
Non-Hodgkin's lymphomas--current status of therapy and future perspectives. [2019]Non-Hodgkin's lymphomas (NHL) are a heterogeneous group of disorders which can either be classified according to their biology, represented by corresponding counterparts of normal lymphocyte development as in the Kiel classification, or according to their clinical course, used in the Working Formulation. The recently proposed Revised European-American Lymphoma (R.E.A.L.) classification may unify both aspects and facilitate the comparability of international studies. Besides histology, the extent of disease still comprises the major determinant of therapy. In high-grade lymphomas combination chemotherapy with cyclophosphamide, hydroxydaunorubin, vincristine and prednisone (CHOP) represents the treatment of first choice, and may be restricted to 3-4 cycles in patients with limited stages of the disease when followed by involved field radiotherapy. In more extended, bulky stage II to IV disease, treatment must be extended to six courses of CHOP and, potentially, additional irradiation. Even in advanced states of the disease, long-term remission and potential cure are achieved in 30-50% of cases. In low-grade lymphomas, most patients present with advanced stages III and IV for which chemotherapy can be applied with palliative intention only. Hence, a watch-and-wait approach still seems appropriate outside clinical investigations until the disease requires a therapeutic intervention. This consists preferentially of chemotherapy of moderate intensity such as cyclophosphamide, vincristine and prednisone (COP) or prednimustine and mitoxantrone (PmM). In responding patients, maintenance therapy with interferon-alpha is currently being explored and may result in prolongation of disease-free and, possibly also, overall survival. In both high- and low-grade lymphomas, intensification of therapy by myeloablative chemotherapy or combined chemoradiotherapy followed by autologous bone marrow transplantation (ABMT) or peripheral stem cell transplantation provides a promising and potentially curative prospective. In addition, new cytostatic agents such as the purine analogues--fludarabine, chlorodeoxyadenosine and deoxycoformycin--enlarge the therapeutic spectrum. More experimental approaches consist of the application of immunotoxins or radioisotypes, coupled to monoclonal antibodies directed against lymphoma-specific antigens. Overall, the substantial advances that have been achieved in the understanding of the biology and pathogenesis of malignant lymphomas, as well as the current achievements of therapy and the new promising perspectives, justify the hope that curative therapy can soon be offered to an increasing proportion of patients with NHL.
A randomized controlled trial of the effect of prednisone omission from a multidrug chemotherapy protocol on treatment outcome in dogs with peripheral nodal lymphomas. [2017]OBJECTIVE To determine the effect of prednisone omission from a multidrug chemotherapy protocol on outcome in dogs with peripheral nodal lymphomas. DESIGN Single-center, nonblinded, parallel-group, randomized, controlled trial. ANIMALS 40 client-owned dogs with a histopathologically confirmed diagnosis of peripheral nodal lymphoma and an expected survival time of > 4 weeks with treatment. PROCEDURES Treatment consisted of a combination of L-asparaginase, cyclophosphamide, doxorubicin, vincristine, and prednisone (L-CHOP) or an identical protocol except for the omission of prednisone (L-CHO). The primary outcome of interest was progression-free survival time. Veterinary caregivers and assessors of outcome were not blinded to treatment assignment. Treatment assignment was concealed from the owners of study dogs prior to enrollment, but was revealed after written informed consent was provided. RESULTS The trial was terminated early because of slow enrollment. The 40 dogs successfully enrolled in the study were randomly assigned to the L-CHOP (n = 18) or L-CHO (22) group; results for all 40 dogs were analyzed with respect to the primary outcome. Median progression-free survival time was 142.5 days for dogs receiving L-CHO and 292 days for dogs receiving L-CHOP (hazard ratio, 1.79; 95% confidence interval, 0.85 to 3.75). Serious adverse events were more common among dogs receiving L-CHO. However, this difference was not significant. CONCLUSIONS AND CLINICAL RELEVANCE The exclusion of prednisone from the L-CHOP protocol did not appear to result in improved progression-free survival time for dogs with peripheral nodal lymphomas. However, the present trial was likely underpowered to detect a clinically meaningful difference in progression-free survival time between groups.
[New antitumor drugs for non-Hodgkin's lymphoma]. [2018]We summarize in this article the antitumor activity of newly developed drugs against non-Hodgkin's lymphoma. The Taxans (paclitaxel and docetaxel), complex polycyclic organic chemicals isolated from the yew tree, have a broad antitumor spectrum with impressive activity in solid tumors. In the SWOG Phase II study on relapsed non-Hodgkin's lymphomas, paclitaxel (Taxol), showed 30% CR and 14% PR. In the CALGB study on docetaxel, a 14.5% response rate (12.5% for low-grade lymphoma and 16.1% for intermediate-high grade lymphoma) was found. In the Japanese phase II study of docetaxel, the response rate was 29.4% for all patients (14.3% for low-grade lymphoma and 40.0% for intermediate-high grade lymphoma). Rituximab is a chimeric monoclonal antibody directed against the B-cell specific antigen CD20. A phase II trial was conducted with four weekly infusions of 375 mg/m2 in patients with relapsed low-grade or follicular lymphoma. The response rate was 46%. A clinical trial combining Rituximab with 6 cycles of CHOP chemotherapy in newly diagnosed patients has recently been completed. Early evaluation of this experience suggests that this combination resulted in a PR or CR in all patients. New purine nucleoside analogs (fludarabine, cladribine, pentostatin) are active against common and generally incurable low-grade lymphoproliferative disorders. These new drugs combined with other chemotherapeutic reagents are expected to overcome refractory or incurable non-Hodgkin's lymphoma.
Randomised trial evaluating chemotherapy alone or chemotherapy and a novel monoclonal antibody for canine T-cell lymphoma: A multicentre US study. [2022]Canine peripheral nodal T-cell lymphoma is considered chemotherapy resistant and carries a relatively poor prognosis. Prospective evaluations reporting the impact of chemotherapy on progression-free survival (PFS) and overall survival time for dogs with T-cell lymphoma are lacking. This study examined the impact of L-CHOP (L-asparaginase, doxorubicin, cyclophosphamide, vincristine, prednisone) chemotherapy or L-CHOP in combination with AT-005, a US Department of Agriculture-licensed caninised monoclonal antibody, on PFS and response rates in dogs with clinical intermediate- and high-grade peripheral nodal T-cell lymphoma.