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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial assesses how the immune system responds to leukemia tumors after low dose radiation delivered as part of standard of care. The information learned in this study may help them know if adding immunotherapy (a type of treatment that uses the immune system to fight cancer) can be helpful in future leukemia patients receiving radiation.

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 data supports the idea that Radiation Therapy for Leukemia is an effective treatment?

The available research shows that radiation therapy can be effective for certain types of leukemia, especially when there are local manifestations of the disease. For example, it is used to manage extramedullary leukemia, which is when the disease spreads outside the blood and bone marrow. Radiation therapy can help control these local issues and improve survival rates. Additionally, in chronic lymphocytic leukemia, total body irradiation has been shown to prolong survival and improve quality of life. Compared to chemotherapy alone, combining radiation with chemotherapy (chemoradiation) has been shown to improve outcomes in similar blood-related cancers, like non-Hodgkin's lymphomas. ^{1 2 3 4 5}

What safety data exists for radiation therapy in leukemia treatment?

The safety data for radiation therapy in leukemia treatment shows mixed results. Low-dose radiation (less than 300 rads) does not significantly increase leukemia risk when administered in small doses over time. However, higher doses, especially when combined with chemotherapy, can increase leukemia risk. Studies on radiotherapy for other conditions, like uterine bleeding and breast cancer, show varying risks, with some increased leukemia incidence at higher doses. Overall, the risk appears to depend on the dose and treatment context. ^{6 7 8 9 10}

Is Low Dose Radiation a promising treatment for leukemia?

Low Dose Radiation can be a promising treatment for leukemia because it helps control the disease and can increase survival time, especially when used in specific areas like the spleen. It is effective in managing certain symptoms and can be combined with other treatments for better results. ^{2 6 7 11 12}

Research Team

Bouthaina S. Dabaja

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of Radiation in Extramedullary Leukemia/Chloroma: Guidelines From the International Lymphoma Radiation Oncology Group. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Hematologic Malignancies. [2021]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The radiation and chemoradiation treatments of generalized low-grade non-Hodgkin's lymphomas. 2. The late results]. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Low-dose radiation and leukemia. [2007]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Human radiation leukemogenesis]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Relationship of leukemia risk to radiation dose following cancer of the uterine corpus. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Leukemia following radiotherapy for uterine bleeding. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Leukemia risk following radiotherapy for breast cancer. [2017]

11. Ireland 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. [2018]

12. Canada pubmed.ncbi.nlm.nih.gov

Radiotherapy in the management of leukemia. [2010]