Radiation Therapy for Leukemia

Overseen By Bouthaina S Dabaja

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Unwilling to participate, Unwilling biopsy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the immune system responds to leukemia tumors after low-dose radiation, a standard care component. The goal is to determine if this approach can enhance the effectiveness of future immunotherapy treatments. Researchers will collect biopsies and blood samples to monitor changes before and after radiation. Individuals diagnosed with new or recurring myeloid leukemia who can undergo a simple biopsy are suitable candidates. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants an opportunity to contribute to groundbreaking advancements in leukemia care.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that low dose radiation is safe for leukemia patients?

Research has shown mixed results regarding the safety of low-dose radiation, such as that used in this study, for treating leukemia. Some studies suggest that low doses (less than 300 rads) do not significantly increase the risk of other health issues. However, other research indicates a possible risk of cancer even with low doses of radiation. While some studies have found no unexpected side effects, this trial remains in its early stages, so limited safety information is available. Participants should consider these findings and discuss them with their healthcare providers for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for leukemia, which usually involve chemotherapy or bone marrow transplants, this approach uses low-dose radiation therapy. Researchers are excited about this treatment because it targets cancer cells with precision while minimizing damage to healthy cells. This method could potentially reduce side effects and improve patients' quality of life. Additionally, the use of biopsies and blood samples before and after treatment provides valuable insights into how the body responds, allowing for more personalized care.

What evidence suggests that low dose radiation might be an effective treatment for leukemia?

Research has shown that low-dose radiation therapy may help treat leukemia, particularly in cases like leukemia cutis. One study found that patients with acute myeloid leukemia (AML) experienced better outcomes after receiving radiation, with leukemia being controlled for an average of 40 months. This suggests that radiation can effectively manage certain types of leukemia. Additionally, animal studies have linked low-dose radiation to reduced stickiness of white blood cells, which might help lower inflammation and slow tumor growth. While more research is needed specifically for leukemia, these findings offer hope that low-dose radiation could be an effective treatment. Participants in this trial will undergo low-dose radiation therapy, with biopsies and blood samples collected to further evaluate its effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Bouthaina S. Dabaja

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with new or recurrent myeloid leukemia who can undergo a biopsy and have an ECOG performance status <4. Women must be non-pregnant, not of childbearing potential, or use contraception; men also need to agree to use contraception until the last radiation treatment.

Inclusion Criteria

I am not able to have children, or I will use birth control during and after the study.

I have been diagnosed with new or recurrent myeloid leukemia.

I can understand and have signed the consent form.

Exclusion Criteria

I am not willing to have a biopsy before or after radiotherapy.

I am willing to participate in the clinical trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo local radiotherapy to extramedullary sites and biopsies are collected before and after therapy

1-2 weeks

Biopsy before and 7-14 days after radiation

Follow-up

Participants are monitored for changes in immune responses and overall response rate, with blood samples collected and photographs taken

4-6 weeks

Blood samples 1 and 7 days post-radiation, photographs at 4-6 weeks

Long-term follow-up

Participants' medical records are reviewed for up to 2 years to assess long-term outcomes

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Low Dose Radiation

Trial Overview The study is looking at how the immune system reacts to leukemia tumors after they've been treated with low dose radiation. It involves procedures like biopsies, collecting biological samples, reviewing electronic health records, and taking photographs of tumors.

How Is the Trial Designed?

Group I: Treatment (biopsy, biospecimen collection) Experimental Treatment 4 Interventions

Patients undergo biopsy prior to radiation therapy and 7-14 days after radiation therapy. Patients also undergo blood sample collection prior to therapy (within 7 days of starting radiation therapy), 1 and 7 days post completion of radiation therapy. Patients' photographs of the biopsy site are taken before and at 4-6 weeks post completion of radiation, and their medical records are reviewed for up to 2 years.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Radiation therapy remains crucial in treating blood cancers, serving various roles such as primary treatment, post-chemotherapy consolidation, and palliative care.

Recent advancements in radiation techniques, like involved-field irradiation and conformal radiation, aim to minimize long-term side effects associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving role of radiation therapy for hematologic malignancies. Lee, CK.[2006]

In a study involving 19 patients with recurrent non-small-cell lung cancer, combining low-dose radiotherapy (LDR) with pemetrexed resulted in a promising overall response rate of 42%, significantly higher than the 9.1% response rate reported for pemetrexed alone.

The treatment was found to have a similar safety profile to standard chemotherapy, with only one patient experiencing severe neutropenia, suggesting that this combination could be a viable option for patients with advanced lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose radiotherapy as a chemo-potentiator of a chemotherapy regimen with pemetrexed for recurrent non-small-cell lung cancer: a prospective phase II study. Mantini, G., Valentini, V., Meduri, B., et al.[2018]

Radiation therapy plays a crucial role in managing adult leukemias, particularly in acute leukemias where it is used for local treatment and CNS prophylaxis to prevent meningeal involvement.

Recent advancements, such as total body irradiation, have shown promise in achieving remissions in chronic lymphocytic leukemia, leading to prolonged survival and improved quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of radiation therapy in management of adult leukemia. Johnson, RE.[2019]

A study of 4483 women treated with radiation for uterine bleeding revealed that their mortality from leukemia was twice as high as expected, particularly peaking 2 to 5 years post-treatment, indicating a significant long-term risk associated with this therapy.

The average radiation dose to active bone marrow was linked to an increased leukemia risk, with a calculated excess relative risk of 1.9% per cGy, suggesting that even low doses of radiation can lead to a higher incidence of leukemia, especially in older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leukemia following radiotherapy for uterine bleeding. Inskip, PD., Monson, RR., Wagoner, JK., et al.[2013]

Total body irradiation with doses over 100 rads of X-rays or lower doses of neutrons is associated with an increased risk of leukemia, and localized or prolonged irradiations maintain this risk at higher total doses.

The study suggests that while linear extrapolation of radiation effects is acceptable for radioprotection, it is not appropriate for predicting risks from low doses, such as those from radiodiagnostic procedures or environmental exposure near nuclear power plants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Human radiation leukemogenesis]. Tubiana, M.[2006]

Radiation therapy is essential for treating various blood cancers, but the optimal dose and target area must be tailored to individual patient factors such as cancer type, stage, and overall health.

Using advanced radiotherapy techniques can help minimize radiation exposure to healthy organs while still effectively controlling the disease, improving patient safety and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hematologic Malignancies. Tseng, YD., Ng, AK.[2021]

A study involving 138 leukemia patients and matched controls found no significant increase in leukemia risk from low-level radiation exposure (less than 300 rads) to the bone marrow, which is typical in routine medical care.

The research suggests that small doses of radiation administered over long periods do not contribute to the development of leukemia, providing reassurance about the safety of diagnostic and low-level therapeutic radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose radiation and leukemia. Linos, A., Gray, JE., Orvis, AL., et al.[2007]

Localized radiation therapy, particularly directed at the spleen, has been shown to increase survival time in patients with chronic leukemias, highlighting its efficacy in treatment.

Alkylating drugs offer a convenient alternative for achieving a whole-body effect in leukemia treatment, allowing patients to manage their care at home while still being monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy in the management of leukemia. King, D.[2010]

In a study of 255 patients with low-grade non-Hodgkin's lymphomas, chemoradiation treatment showed better total and relapse-free survival rates compared to chemotherapy alone.

Intensifying the components of the chemoradiation regimen further improved late outcomes, and complete remissions were identified as key predictors of survival, while local radiation therapy was effective for a small subset of patients with slow-progressing diffuse lymphocytic NHL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The radiation and chemoradiation treatments of generalized low-grade non-Hodgkin's lymphomas. 2. The late results]. Kharchenko, VP., Sotnikov, VM., Pan'shin, GA., et al.[2007]

In a study of 110,000 women with uterine corpus cancer, radiotherapy was found to significantly increase the risk of developing leukemia (excluding chronic lymphocytic leukemia) with a relative risk of 1.92, indicating a notable association between partial-body radiotherapy and leukemia risk.

The risk of leukemia was similar for both brachytherapy and external-beam therapy, suggesting that even low doses of radiation can carry a risk, but the overall leukemia risk from radiotherapy was small, with only about 14 excess cases per 10,000 women followed for 10 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of leukemia risk to radiation dose following cancer of the uterine corpus. Curtis, RE., Boice, JD., Stovall, M., et al.[2022]

In a study of 22,753 women who survived invasive breast cancer, high-dose radiotherapy (average dose of 530 rad) did not significantly increase the overall risk of developing leukemia, with a relative risk of only 1.16.

The research found no significant increase in the risk of chronic lymphocytic leukemia or other forms of leukemia, suggesting that high radiation doses primarily cause cell death rather than cell transformation, thus indicating a lack of association between radiotherapy and leukemia risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leukemia risk following radiotherapy for breast cancer. Curtis, RE., Boice, JD., Stovall, M., et al.[2017]

Survival rates for leukemia patients have significantly improved due to better understanding of the disease's genetics and advancements in chemotherapy and targeted therapies.

Radiation therapy plays a crucial role in managing extramedullary relapses of leukemia, which can be challenging to treat with standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Radiation in Extramedullary Leukemia/Chloroma: Guidelines From the International Lymphoma Radiation Oncology Group. Bakst, RL., Dabaja, BS., Specht, LK., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11256586/

Low-dose ionizing radiation exposure and risk of leukemia We found a positive relationship between 2-year lagged cumulative red bone marrow dose and risk of leukemia excluding chronic lymphocytic leukemia (CLL) (ERR = ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11819161/

The effectiveness of radiotherapy for leukemia cutis - PMC AML patients had a better long-term outcome than the other patients according to median DOLC (40 months versus 2 months, respectively; P < 0.001) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1507136720300183

Review Low-Dose radiation therapy for benign pathologies Moreover, through mice studies, a decreased adhesion of leucocytes has been showed with 0.3 Gy as lowest effective dose, and it is suggested that anti ...

4. redjournal.org redjournal.org/article/S0360-3016(25)00439-0/fulltext

A Retrospective Single-Institution Analysis of 69 Patients ... Low-dose radiation therapy (LDRT) has emerged as a promising noninvasive treatment for OA, with encouraging results reported in European studies.

5. astro.org astro.org/meetings-and-education/micro-sites/2025/annual-meeting/daily-news/thursday/article-abstract-lymphoma

How Low Can You Go? - Daily News After a median follow-up of 2.1 years, an impressive 94% of patients remained disease free with only four experiencing local recurrences in the entire cohort, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12427289/

Clinical Outcomes and Safety of Ultra-Low-Dose ... Progression-free survival at 2 years ranged from 85% to 100%, while OS exceeded 98%, indicating excellent long-term outcomes. Importantly, ULD- ...

7. ashpublications.org ashpublications.org/ashclinicalnews/news/2301/Exposure-to-Ionizing-Radiation-and-Leukemia-Risk

Exposure to Ionizing Radiation and Leukemia Risk According to the findings, even low accrued doses of radiation (<5 mGy) had an excess risk of leukemia-related mortality, suggesting that the potential ...

8. dceg.cancer.gov dceg.cancer.gov/news-events/news/2020/low-dose-monograph

Low Dose Ionizing Radiation Shown to Cause Cancer in ... The authors found clear evidence of excess cancer risk from low dose ionizing radiation: 17 of 22 studies showed risk for solid cancers and 17 of 20 studies ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e19507

Safety of concurrent use of radiotherapy for second primary ... There were no cases of RT dose modification. Conclusions: Continuing NA CLL therapy during RT did not result in unexpected toxicities. This ...

10. withpower.com withpower.com/trial/radiation-therapy-for-leukemia-20439

Radiation Therapy for Leukemia · Info for Participants The safety data for radiation therapy in leukemia treatment shows mixed results. Low-dose radiation (less than 300 rads) does not significantly increase ...