40 Participants Needed

PET Adapted Therapy for Non-Hodgkin's Lymphoma

RB
Overseen ByRobin Boerman
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

This treatment is unique because it uses PET scans to adapt the therapy based on the patient's response, combining drugs like rituximab with a chemotherapy regimen (cyclophosphamide, doxorubicin, vincristine, prednisone) to potentially improve outcomes compared to standard treatments.2891011

Research Team

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Carla Casulo, MD

Principal Investigator

University of Rochester

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

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
  • Doxorubicin
  • Prednisone
  • Rituximab
  • Vincristine
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:

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Approved in United States as Cytoxan for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma
  • Rheumatoid arthritis
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Approved in European Union as Endoxan for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma
  • Rheumatoid arthritis
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Approved in Canada as Neosar for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma
  • Rheumatoid arthritis
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Approved in Japan as Endoxan for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

Findings from Research

Salvage chemotherapy followed by high-dose therapy and autologous stem cell transplantation is the standard treatment for relapsed diffuse large B-cell lymphoma, but the addition of rituximab has improved outcomes after first-line treatment and relapses.
The CORAL trial found no significant difference in response rates between two salvage regimens (R-ICE and R-DHAP), and identified that factors like early relapse and certain genetic markers significantly affect survival, indicating that over 70% of patients may not benefit from standard salvage therapy.
Is there any role for transplantation in the rituximab era for diffuse large B-cell lymphoma?Gisselbrecht, C.[2022]
In a study of 23 patients with aggressive B-cell non-Hodgkin lymphoma, the combination of rituximab with CODOX-M/IVAC showed promising efficacy, with 83% of low-risk and 71% of high-risk patients achieving complete remission after treatment.
The safety profile was acceptable, with no treatment-related deaths and manageable toxicity, including only two cases of grade 3 neutropenia, suggesting that this treatment combination is both effective and safe for patients.
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%.Mohamedbhai, SG., Sibson, K., Marafioti, T., et al.[2015]
In a study of 91 people living with HIV and Burkitt lymphoma, adding rituximab to CODOX-M/IVAC chemotherapy did not increase severe treatment-related toxicities, indicating it is a safe option for this population.
The addition of rituximab significantly improved both overall survival (72% vs. 55%) and progression-free survival (81% vs. 55%) compared to chemotherapy alone, suggesting it enhances treatment efficacy without added risks.
Adding rituximab to CODOX-M/IVAC chemotherapy in the treatment of HIV-associated Burkitt lymphoma is safe when used with concurrent combination antiretroviral therapy.Alwan, F., He, A., Montoto, S., et al.[2022]

References

Is there any role for transplantation in the rituximab era for diffuse large B-cell lymphoma? [2022]
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]
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]
Efficacy and toxicity of PACEBOM chemotherapy in relapsed/refractory aggressive lymphoma in the rituximab era. [2018]
Pilot study of modified version of CHOP plus radiotherapy for early-stage aggressive non-Hodgkin's lymphoma of the head and neck. [2015]
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]
Treatment of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. [2022]
Current therapeutic paradigm for the treatment of non-Hodgkin's lymphoma. [2006]
The effect of common antineoplastic agents on induction of apoptosis in canine lymphoma and leukemia cell lines. [2014]
Treatment of canine lymphoma by veterinarians in first opinion practice in England. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Chemotherapy alone compared with chemotherapy plus radiotherapy for localized intermediate- and high-grade non-Hodgkin's lymphoma. [2022]