Low Dose Radiation Therapy for Mantle Cell Lymphoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This phase II trial studies how well ultra low dose radiation works before or after chemotherapy-free targeted therapy in treating patients with mantle cell lymphoma that has come back or does not respond to treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Ultra low dose radiation is generally associated with a lower risk of side effects which may allow patients to be able to receive low-dose radiation therapy more often than high-dose radiation therapy. This trial may help doctors learn if giving ultra low dose radiation helps control mantle cell lymphoma and improves response to chemotherapy free targeted therapy.
Is low dose radiation therapy a promising treatment for mantle cell lymphoma?Yes, low dose radiation therapy is a promising treatment for mantle cell lymphoma. It is effective in controlling the disease, even in patients who have not responded well to other treatments. It can help achieve remission and is safe to use with minimal side effects. This makes it a valuable option for managing the disease and improving patient outcomes.23568
What safety data exists for low dose radiation therapy in mantle cell lymphoma?The safety data for low dose radiation therapy (LDRT) in low-grade lymphomas, including mantle cell lymphoma, indicates minimal toxicity. Studies show that LDRT, often administered as 2 x 2 Gy, is effective with high response rates and minimal adverse effects, typically not exceeding grade 1 toxicity. This suggests that LDRT is a safe treatment option for patients with low-grade lymphomas, providing effective palliation with low toxicity.24789
What data supports the idea that Low Dose Radiation Therapy for Mantle Cell Lymphoma is an effective treatment?The available research shows that Low Dose Radiation Therapy (LDRT) is effective for treating Mantle Cell Lymphoma (MCL), especially in patients who have not responded well to other treatments. In one study, 81% of patients with relapsed MCL achieved a complete response after receiving LDRT, even when other treatments had failed. Additionally, 90% of these patients survived for at least one year after starting LDRT. This suggests that LDRT can help control the disease and improve survival rates. Compared to chemotherapy alone, combining LDRT with chemotherapy can lead to better outcomes, as it helps achieve remission and manage the disease more effectively.12358
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, since the trial involves radiation therapy, it's best to discuss your current medications with the trial doctors to ensure there are no interactions or safety concerns.
Eligibility Criteria
This trial is for patients with mantle cell lymphoma that has returned or isn't responding to treatment. They must have had at least two prior therapies, be in a stable condition (ECOG performance status of 2 or less), and have measurable disease. Women must not be pregnant and agree to birth control measures; men also need to use contraception if with a partner who can bear children.Inclusion Criteria
My cancer has worsened after treatment with ibrutinib, shown by PET/CT scans.
I have been diagnosed with mantle cell lymphoma confirmed by a tissue biopsy.
I can do most of my daily activities on my own.
My kidneys are functioning well enough to clear waste.
My white blood cell count is above 1000 and my platelet count is above 25,000.
Exclusion Criteria
I've had radiation before where they now want to target, and more is unsafe.
My brain lymphoma needs treatment before any other cancer treatments.
Participant Groups
The study is testing ultra low dose radiation therapy before or after targeted therapy without chemotherapy in patients with relapsed/refractory mantle cell lymphoma. The goal is to see if this approach helps control the cancer better and improves responses compared to standard treatments.
1Treatment groups
Experimental Treatment
Group I: Treatment (ultra low dose radiation therapy)Experimental Treatment1 Intervention
Patients undergo ultra low dose radiation for 1-2 days before chemotherapy free-targeted therapy. Patients may receive a second, longer course of radiation if the lesion treated does not respond.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
[The radiation and chemoradiation treatments of generalized low-grade non-Hodgkin's lymphomas. 2. The late results]. [2007]Late outcomes of radiation and chemoradiation treatments and chemotherapy were analysed in 255 patients with low-grade generalized non-Hodgkin's lymphomas (NHL). In terms of total and relapse-free survival, chemoradiation treatment regimen yields the best results, as compared to chemotherapy. There is a general trend to improve the late outcomes when each of two components of the chemoradiation regimen is intensified. Chemoradiation treatment improves late outcomes not only in primary patients, but in patients with relapses after radiation or chemical therapy. Complete remissions are one of the most important predictors of total and relapse-free survival. There is a small group of patients with a diffuse lymphocytic type of NHL (about 10-15%). which is characterized by extremely slow disease progression and enlargement of individual lymph organs (tonsils, lymph nodes, spleen) in whom long-term total and relapse-free survival can be achieved by local radiation therapy.
Value of low-dose 2 x 2 Gy palliative radiotherapy in advanced low-grade non-Hodgkin's lymphoma. [2018]Low-dose radiotherapy over the last decade has been reported to provide effective palliation for patients with low-grade non-Hodgkin's lymphoma. In this retrospective case series of 10 patients, we report our early experience using low-dose radiotherapy (usually 2 x 2 Gy) for patients with advanced-stage follicular, mucosal associated lymphoid tissue, mantle cell and small lymphocytic lymphomas. Median follow up was 27 weeks. Response rates were high (complete response, 70%; partial response, 20%), the response durable and the toxicity was minimal (no toxicity greater than grade 1). Low-dose irradiation is an effective treatment option for patients with low-grade lymphomas with local symptoms.
Radiation therapy is an effective modality in the treatment of mantle cell lymphoma, even in heavily pretreated patients. [2022]Mantle cell lymphoma has an aggressive clinical course and continuous relapse pattern with a median survival of 3 to 7 years. Multiple courses of chemotherapy are the basis of treatment. Radiotherapy is underutilized in this disease. We undertook this study to assess the role of radiation therapy.
Response rates and recurrence patterns after low-dose radiotherapy with 4 Gy in patients with low-grade lymphomas. [2019]Retrospective study of effectiveness, toxicity, and relapse patterns after low-dose radiotherapy (LDRT) in patients with low-grade lymphomas.
Low-dose radiation (4 Gy) with/without concurrent chemotherapy is highly effective for relapsed, refractory mantle cell lymphoma. [2020]Mantle cell lymphoma (MCL) generally exhibits an aggressive disease course with poor outcomes. Despite inherent radiosensitivity, radiation therapy (RT) is not commonly used for MCL. This study assesses the role of low-dose RT (LDRT) with concurrent chemotherapy in relapsed, multiply refractory MCL. From 2014 through 2018, 19 patients with relapsed, refractory MCL had 98 sites treated with 4 Gy. Median follow-up from initial LDRT was 15.4 months. Patients had received a median 7 courses of chemotherapy since diagnosis, and 58% were ibrutinib-refractory. Of the 98 sites, 76% were refractory to ongoing chemotherapy, and LDRT was delivered with concurrent chemotherapy for 76%. The complete response (CR) rate was 81% at a median 2.7 months post-LDRT. There were no differences in CR despite ibrutinib-refractory disease, prior chemotherapy courses (>5), or tumor size (>3 cm). There were no RT-related toxicities. Overall survival at 1 year following initial LDRT was 90%, and 1-year progression-free survival following last course was 55%. In summary, LDRT is effective for relapsed, multiply refractory MCL, and may be safely delivered with chemotherapy, to multiple sites, and repeatedly without issue. By treating active sites of disease, LDRT can provide durable local control, help achieve remission, and potentially bridge patients to subsequent novel therapies.
Radiotherapy in mantle cell lymphoma: A literature review. [2020]Mantle cell lymphoma (MCL) is a B-cell malignancy, comprising between 3% and 10% of all adult-onset non-Hodgkin lymphomas. MCL is considered incurable with current treatment modalities and most patients require multiple lines of treatment during their lifetime. MCL is very sensitive to radiotherapy (RT), even when delivered in low doses. In limited-stage MCL, RT can enable the de-escalation of systemic therapy. RT monotherapy is a valid option for frail patients. In advanced-stage disease, RT is very potent mode of palliation, even in heavily pretreated and chemo-resistant patients. Furthermore, it can provide a respite during which systemic treatment is unnecessary. In general, RT has a favorable toxicity profile and can be repeated as necessary for local relapse or distant disease. This effective, safe, and relatively inexpensive modality of therapy has been underutilized for patients with MCL. In this review, we will outline the use of RT for limited and advanced-stage disease and its potential application in combination with novel drugs.
Adverse Events and Economic Burden Among Patients Receiving Systemic Treatment for Mantle Cell Lymphoma: A Real-World Retrospective Cohort Study. [2021]Limited published real-world data describe adverse events (AEs) among patients treated for mantle-cell lymphoma (MCL). The aim of this retrospective study was to describe treatment patterns, AEs, and associated healthcare costs.
Ultra-low dose radiotherapy in the management of low-grade orbital lymphomas. [2022]Ultra-low dose radiotherapy (ULDRT) (2 × 2 Gy) has been used for symptomatic control of low-grade lymphomas with surprising local control rates, suggesting that these entities could respond to lower doses. These are particularly desirable for the treatment of orbital sites and some publications refer to high rates of complete responses. In this paper, we present our experience with the use of ULDRT for indolent orbital lymphomas.
High local control and low ocular toxicity using ultra-low-dose "boom-boom" radiotherapy for indolent orbital lymphoma. [2023]The first line definitive treatment for early-stage indolent B-cell lymphoma is radiation therapy (RT). Due to the sensitivity of orbital structures to radiation, ultra-low-dose RT (4 Gy in 2 fractions, "boom-boom") has and been utilized as an attractive option for orbital lymphoma. In this retrospective study, we evaluated the outcome and toxicity of "boom-boom" RT for indolent orbital lymphoma with an emphasis on ophthalmologic toxicity.