10 Participants Needed

Radiation Therapy for B-Cell Lymphoma

(HyDEF Trial)

SL
Overseen ByStephanie Ladd
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the feasibility and safety of a novel method for comparing the effectiveness of hypofractionated versus hyperfractionated radiation therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) undergoing T-cell redirection therapies (CAR T-cell therapy or bispecific antibodies).

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is Hyperfractionated Dual Equivalent Fractionated Radiation Therapy safe for humans?

In a study of hyperfractionated radiation therapy for primary cerebral lymphoma, all patients achieved complete remission, but some experienced neurological deterioration and radiation brain injury, leading to the study's closure due to treatment toxicity. However, other reports suggest this regimen is generally free from significant harm.12345

How is Hyperfractionated Dual Equivalent Fractionated Radiation Therapy different from other treatments for B-Cell Lymphoma?

Hyperfractionated Dual Equivalent Fractionated Radiation Therapy is unique because it involves giving smaller doses of radiation more frequently, which allows for higher total doses without exceeding the tolerance of the central nervous system. This approach aims to improve outcomes by reducing the risk of local relapse compared to conventional radiation therapy.16789

What data supports the effectiveness of the treatment Hyperfractionated Dual Equivalent Fractionated Radiation Therapy for B-Cell Lymphoma?

Research on hyperfractionated radiation therapy, a component of the treatment, shows it can improve outcomes by allowing higher doses without increasing side effects, as seen in studies on head and neck cancer and primary cerebral lymphoma. These studies suggest that hyperfractionation may enhance local control and survival rates compared to conventional radiation therapy.110111213

Who Is on the Research Team?

TJ

Timothy J Robinson, MD PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for people with relapsed/refractory diffuse large B-cell lymphoma who are undergoing T-cell redirection therapies. Participants should meet specific health criteria to be eligible.

Inclusion Criteria

I can care for myself but may not be fully active.
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
See 3 more

Exclusion Criteria

I am not a candidate for intensive radiotherapy due to my condition or doctor's advice.
Participants who are pregnant or currently breastfeeding
Participants with history of prior radiation exposure for research purposes within the past year, such that participation in this study would place them over the FDA limits for annual radiation exposure
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive dual fractionated radiation therapy as a bridge to T-cell directed therapy, with one area receiving once daily and the other twice daily radiation

Approximately 1 year

Follow-up

Participants are monitored for safety and effectiveness after radiation therapy

Approximately 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Hyperfractionated Dual Equivalent Fractionated Radiation Therapy
Trial Overview The study is testing a new radiation therapy method, comparing hypofractionated (fewer, larger doses) versus hyperfractionated (more, smaller doses) approaches in patients awaiting CAR T-cell therapy or bispecific antibodies.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Dual Hyperfractionated Radiation TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

American Cancer Society, Inc.

Collaborator

Trials
237
Recruited
110,000+

Published Research Related to This Trial

The UK-FAST trial showed that a once weekly hypofractionated radiotherapy regimen (5 fractions of 5.7 Gy) for whole breast irradiation had similar toxicity levels compared to the conventional regimen (50 Gy in 25 fractions) over a 10-year follow-up, indicating it is a safe alternative.
The FAST-Forward trial demonstrated that a 5-fraction regimen (5.2 Gy per fraction) over one week is non-inferior in local control compared to the standard 40 Gy in 15 fractions over three weeks, supporting the efficacy of extreme hypofractionation in breast cancer treatment.
[Extreme hypofractionation: New indications for breast cancer radiotherapy].Bockel, S., Louvel, G., Brion, T., et al.[2021]
In a phase II trial involving 107 patients with high-risk, relapsed or refractory B-cell non-Hodgkin lymphoma, high-dose radioimmunotherapy (I-131-tositumomab) combined with chemotherapy before autologous stem-cell transplant showed promising long-term outcomes, with 10-year progression-free survival rates ranging from 43% to 64%.
The treatment was found to be feasible and safe, with a low non-relapse mortality rate of 2.8% at 100 days and similar toxicity profiles to standard regimens, suggesting that high-dose RIT could be a viable option alongside newer therapies for this patient population.
A phase II trial evaluating the efficacy of high-dose Radioiodinated Tositumomab (Anti-CD20) antibody, etoposide and cyclophosphamide followed by autologous transplantation, for high-risk relapsed or refractory non-hodgkin lymphoma.Chow, VA., Rajendran, JG., Fisher, DR., et al.[2021]

Citations

Altered fractionation in radiation therapy for squamous-cell carcinoma of the head and neck. [2019]
Phase I study of hyperfractionated whole brain irradiation (HWBI) in the treatment of primary cerebral lymphoma. [2019]
Hyperfractionated radiotherapy of human tumors: overview of the randomized clinical trials. [2019]
Altered fractionation in definitive irradiation of squamous cell carcinoma of the head and neck. [2019]
Altered fractionation schedules in radiation treatment: a review. [2022]
Relation between Hypofractionated Radiotherapy, Toxicity and Outcome in Early Breast Cancer. [2018]
Ultrahypofractionated versus hypofractionated and conventionally fractionated radiation therapy for localized prostate cancer: A systematic review and meta-analysis of phase III randomized trials. [2022]
[Extreme hypofractionation: New indications for breast cancer radiotherapy]. [2021]
Acute skin toxicity of conventional fractionated versus hypofractionated radiotherapy in breast cancer patients receiving regional node irradiation: the real-life prospective multicenter HYPOBREAST cohort. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
A phase II trial evaluating the efficacy of high-dose Radioiodinated Tositumomab (Anti-CD20) antibody, etoposide and cyclophosphamide followed by autologous transplantation, for high-risk relapsed or refractory non-hodgkin lymphoma. [2021]
The effects of ultrafractionated X-ray therapy in malignant lymphomas. [2007]
Importance of PET/CT scan use in planning radiation therapy for lymphoma. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Response to hyperfractionated accelerated radiotherapy in chemotherapy-refractory non-Hodgkin lymphoma. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity