PET Adapted Therapy for Non-Hodgkin's Lymphoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Rochester
Disqualifiers: Pregnancy, Bulky disease, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug combination used in PET Adapted Therapy for Non-Hodgkin's Lymphoma?
Research shows that adding rituximab to chemotherapy regimens like CODOX-M/IVAC can improve survival rates in certain types of lymphoma, including non-Hodgkin's lymphoma. Additionally, the combination of drugs like cyclophosphamide, doxorubicin, vincristine, and prednisone has been effective in treating aggressive forms of lymphoma.12345
Is PET Adapted Therapy for Non-Hodgkin's Lymphoma safe for humans?
The combination of rituximab with CODOX-M/IVAC chemotherapy, which includes drugs like cyclophosphamide, doxorubicin, and vincristine, has been studied in patients with non-Hodgkin's lymphoma and found to have a safety profile comparable to existing treatments, with no treatment-related deaths reported. Some patients experienced side effects like neutropenia (low white blood cell count), but these were manageable. Overall, the treatment was generally well tolerated in studies.23567
What makes the PET Adapted Therapy for Non-Hodgkin's Lymphoma unique?
Eligibility Criteria
This trial is for adults over 18 with early stage, non-bulky Diffuse Large B-Cell Lymphoma (DLBCL) who haven't been treated before. Participants need measurable disease visible on PET scans and available tumor biopsies. They must have good heart, kidney, liver function, stable blood counts, and no uncontrolled health issues or pregnancy.Inclusion Criteria
All my other health conditions are under control.
My liver functions are within normal limits, or slightly elevated if I have Gilbert's disease.
My cancer can be seen and measured on a PET scan.
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Exclusion Criteria
My cancer is larger than 10 cm in size.
Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive standard chemoimmunotherapy and radiation based on the SWOG S1001 study
6-8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of ctDNA at pre-defined time points
12 weeks
Treatment Details
Interventions
- Cyclophosphamide (Alkylating agents)
- Doxorubicin (Anti-tumor antibiotic)
- Prednisone (Corticosteroid)
- Rituximab (Monoclonal Antibodies)
- Vincristine (Vinca alkaloids)
Trial OverviewThe study tests how well patients respond to a combination of drugs: Vincristine, Prednisone, Rituximab Prednisone, Cyclophosphamide, Doxorubicin. It also monitors circulating tumor DNA levels in the body to potentially adapt treatment based on response.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Baseline PETExperimental Treatment5 Interventions
R-CHOP
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Cytoxan for:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
🇪🇺 Approved in European Union as Endoxan for:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
🇨🇦 Approved in Canada as Neosar for:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
🇯🇵 Approved in Japan as Endoxan for:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of RochesterRochester, NY
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Who Is Running the Clinical Trial?
University of RochesterLead Sponsor
References
Is there any role for transplantation in the rituximab era for diffuse large B-cell lymphoma? [2022]Salvage chemotherapy followed by high-dose therapy and autologous stem cell transplantation is the standard of treatment for chemosensitive relapses in diffuse large B-cell lymphoma. The addition of rituximab to chemotherapy has improved the response rate and failure-free survival after first-line treatment and relapses. Fewer relapses are expected, although there is no consensus on the best salvage regimen. The intergroup Collaborative Trial in Relapsed Aggressive Lymphoma (CORAL) set the limits for this standard of treatment after first comparing 2 salvage regimens: rituximab, ifosfamide, etoposide, and carboplatin (R-ICE) and rituximab, dexamethasone, aracytine, and cisplatin (R-DHAP). There was no difference in response rates or survivals between these salvage regimens. Several factors affected survival: prior treatment with rituximab, early relapse (
Rituximab in combination with CODOX-M/IVAC: a retrospective analysis of 23 cases of non-HIV related B-cell non-Hodgkin lymphoma with proliferation index >95%. [2015]The safety and efficacy of rituximab with CODOX-M/IVAC (cyclophosphamide, doxorubicin, vincristine, methotrexate/ifosfamide, etoposide, high dose cytarabine) was retrospectively analysed in 23 patients with non-human immunodeficiency virus-related B-cell non-Hodgkin lymphoma with proliferation index >95% [14 with classical Burkitt lymphoma (BL), five with B-cell lymphoma unclassifiable, with features intermediate between diffuse large B cell lymphoma (DLBCL) and BL, and four with DLBCL]. Six (26%) low-risk (LR) patients received three cycles of CODOX-M and 17 (74%) high-risk (HR) cases were assigned to four cycles of alternating CODOX-M/IVAC. Rituximab 375 mg/m² was infused on days 1 and 10 of each cycle. Toxicity was comparable to that reported with CODOX-M/IVAC, with no treatment-related death. Two patients developed grade 3 rituximab-induced delayed neutropenia, with no adverse outcome. After completing treatment, 83% LR patients and 71% HR patients achieved CR by positron emission tomography-computerized tomography (PET-CT). Three (13%) patients received salvage treatment. At a median follow-up of 34 months (range = 18-75), 19 (83%) patients (100% LR and 74% HR) were alive, including one case undergoing salvage for late relapse. Four HR patients (17%) had died, three from primary progressive disease and one from treatment-refractory relapse 2 months after achieving CR. These results with R-CODOX-M/R-IVAC compare favourably with existing data using CODOX-M/IVAC and warrant further prospective studies. The potential pitfalls of PET-CT to assess response are highlighted.
Adding rituximab to CODOX-M/IVAC chemotherapy in the treatment of HIV-associated Burkitt lymphoma is safe when used with concurrent combination antiretroviral therapy. [2022]CODOX-M/IVAC (cyclophosphamide, vincristine, doxorubicin-methatrexate/ifusamide, etoposide, cytarabine) chemotherapy is commonly used to treat Burkitt lymphoma and in the HIV-negative population. Rituximab is often added with suggested survival benefits. Concerns over increased toxicity in an already immunocompromized population have prevented its routine addition in people living with HIV (PLWH). This study evaluated the effect on treatment-related toxicity and efficacy of adding rituximab to CODOX-M/IVAC chemotherapy in PLWH.
Efficacy and toxicity of PACEBOM chemotherapy in relapsed/refractory aggressive lymphoma in the rituximab era. [2018]Relapsed/refractory (R/R) aggressive lymphoma outcomes are poor. There is no standard treatment. PACEBOM (prednisolone, doxorubicin, cyclophosphamide, etoposide, bleomycin, vincristine and methotrexate) has shown efficacy for several lymphoma subtypes in published reports. We evaluate PACEBOM+/-rituximab for R/R aggressive lymphomas in this millennium.
Pilot study of modified version of CHOP plus radiotherapy for early-stage aggressive non-Hodgkin's lymphoma of the head and neck. [2015]To evaluate the safety and efficacy of a modified version of cyclophosphamide, doxorubicin, vincristine, prednisone (pirarubicin, cyclophosphamide, vincristine, and prednisone [THP-COP]) plus radiotherapy for early-stage aggressive non-Hodgkin's lymphoma of the head and neck.
Phase II study of a salvage regimen using cyclophosphamide, high-dose cytarabine, dexamethasone, etoposide, and rituximab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. [2022]The management of relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) remains challenging. We investigated the efficacy and safety of salvage chemoimmunotherapy (CHASER) in patients with relapsed or refractory B-NHL who had radiographically measurable disease and adequate major organ function. The CHASER treatment consisted of: rituximab 375 mg/m(2), day 1; cyclophosphamide 1200 mg/m(2), day 3; cytarabine 2 g/m(2), days 4 and 5; etoposide 100 mg/m(2), days 3-5; and dexamethasone 40 mg, days 3-5. The treatment was repeated every 3 weeks up to a total of four courses in the absence of disease progression. Thirty-two patients were enrolled and received a median of four courses of treatment (range 1-4 courses) per patient. Twenty patients (63%) were previously treated with rituximab-containing regimens. The median age was 54 years (range 28-67 years). The treatment was generally well tolerated, with major toxicities being grade 4 neutropenia (n = 32), thrombocytopenia requiring transfusion (n = 28), and grade 3 transaminase elevation (n = 2). Overall response rates in the entire group, and in patients with indolent (n = 17) and aggressive (n = 15) diseases were 84%, 100% and 67%, respectively. Responses were observed similarly in patients with (n = 20) and without (n = 12) previous rituximab exposure (85% and 83%, respectively). Stem cell harvest was successful in 19 of 22 patients. The median time to treatment failure for the entire group was 24.5 months. This promising result of high activity and favorable toxicity profile warrants further investigation in large-scale multicenter trials.
Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. [2022]To determine the safety and efficacy of the combination of the chimeric anti-CD20 antibody, Rituxan (Rituximab, IDEC-C2B8; IDEC Pharmaceuticals Corporation, San Diego, CA), and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy.
Current therapeutic paradigm for the treatment of non-Hodgkin's lymphoma. [2006]Patients with indolent non-Hodgkin's lymphoma may be treated with various approaches ranging from deferred initial therapy (watch and wait) to single-agent alkylating agents, radiation therapy, or combination chemotherapy. None of these approaches have produced curative results. Clearly, innovative treatment strategies are needed. The use of interferon, monoclonal antibodies with or without radioisotopes, purine analogues, and even high-dose therapy with stem-cell rescue are under investigation. Based on the fact that fewer than 40% of advanced-stage, aggressive non-Hodgkin's lymphoma patients are cured with cyclophosphamide/doxorubicin/vincristine/prednisone chemotherapy, the best approach for any patient is an experimental one. Examples include: (1) increasing the dose intensity of drugs used in standard regimens; (2) preventing the development of drug resistance; (3) combining monoclonal antibodies with chemotherapy; or (4) autologous stem-cell transplantation as a rescue from marrow-ablative chemotherapy. If a patient is not eligible or does not wish to participate in a clinical trial, cyclophosphamide/doxorubicin/vincristine/prednisone, as inadequate as it is, remains the gold standard.
The effect of common antineoplastic agents on induction of apoptosis in canine lymphoma and leukemia cell lines. [2014]Lymphoma, the most common hematopoietic cancer in dogs is sensitive to chemotherapy which is the dominant treatment method. The aim of the present study was to evaluate the concentration-dependent cytotoxicity and ability to induce apoptosis of the anti-neoplastic agents cyclophosphamide (CYC), chlorambucil (CBL), cytosine arabinoside (ARA), dexamethasone (DEX), doxorubicin (DOX), etoposide (ETO), lomustine (LOM), prednisone (PRED) and vincristine (VINK) against GL-1, CL-1, CLBL-1 and Jurkat cell lines.
Treatment of canine lymphoma by veterinarians in first opinion practice in England. [2019]A survey of canine lymphoma treatment strategies by veterinarians in first opinion practice was undertaken by sending questionnaires to 1000 randomly selected, first opinion small animal veterinary practices throughout England. Completed replies were received from 382 veterinarians. Ninety-five per cent of respondents had diagnosed canine lymphoma in the preceding 12 months. Eighty-seven per cent of respondents treated at least 50 per cent of the cases of canine lymphoma they diagnosed. A multidrug combination of vincristine, cyclophosphamide and prednisolone (COP) was the treatment protocol most commonly used. A doxorubicin-based treatment protocol was used by 2 per cent of respondents to treat canine lymphoma initially. The study suggests that, despite several reports of improved survival times with doxorubicin-based protocols, most veterinarians in first opinion practice in England treat canine lymphoma with COP.
Chemotherapy alone compared with chemotherapy plus radiotherapy for localized intermediate- and high-grade non-Hodgkin's lymphoma. [2022]Patients with clinically localized, intermediate- or high-grade non-Hodgkin's lymphoma usually receive initial treatment with a doxorubicin-containing regimen such as cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Pilot studies suggest that eight cycles of CHOP alone or three cycles of CHOP followed by involved-field radiotherapy are effective in such patients.