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Radiation

Radiation Therapy for Leukemia

Phase < 1

Recruiting

Led By Bouthaina S Dabaja

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients diagnosed with new or recurrent myeloid leukemia

Aged >= 18 years old

Must not have

Patients unwilling to undergo the biopsy before or after radiotherapy

Patients who are unwilling to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well the immune system responds to leukemia tumors after low-dose radiation therapy. They want to see if adding immunotherapy could help future patients receiving radiation for leukemia.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for these interventions since they're mostly observational and diagnostic in nature, typical risks may include discomfort from biopsies and exposure to radiation during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with new or recurrent myeloid leukemia.

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I am 18 years old or older.

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My tumor can be biopsied without special imaging.

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I can care for myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am willing to participate in the clinical trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 2 trial • 59 Patients • NCT02150213

Renal Cyst

Adrenal Adenoma

Ovarian cyst

Angiomyolipoma

100%

80%

60%

40%

20%

Study treatment Arm

BGG492

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (biopsy, biospecimen collection)Experimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 3

~2020