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A Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma

Primary Purpose

Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ultra Low Dose 4 Gy Radiation
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients 18 years or older. Because no RT dosing data are currently available on the use of response adapted ultra low dose RT in patients <18 years of age, children are excluded from this study. Patients with stage I-II marginal zone lymphoma. Patients with a pathology report consistent with low grade B cell lymphoma, favor marginal zone lymphoma, are included. Other low grade lymphomas including follicular grade I/II and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible. Patients should not be planned for any systemic therapy before the first follow up evaluation after radiation (intent is to treat with radiation therapy alone). Patients with biopsy-proven disease treated with another modality (such as systemic therapy) prior to radiation must have clinical or radiographic evidence of residual disease before enrollment. Patients with clinical and/or radiographic masses that are measurable will have dimensions noted prior to therapy. If an excisional biopsy is performed, patients should have clinically or radiographically apparent disease after biopsy (this does not apply to gastric MALT lymphoma patients). Prior systemic therapy is allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy. There are no limits on the nature or amount of prior systemic therapy. Prior antibiotics intended to treat marginal zone lymphoma are allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy. Prior topical therapies (e.g. steroid) intended to treat cutaneous lymphoma are allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy. For patients with gastric MALT lymphoma, H. pylori testing by immunohistochemistry on tissue biopsy is required on most recent pathologic specimen prior to protocol enrollment. Secondary testing for H. pylori with stool and/or urea breath tests and/or serum antigen is strongly recommended. Testing for the MALT1 translocation (t11:18) is strongly recommended if tissue for testing is available. Female patients with childbearing potential must have a negative serum or urine pregnancy test (βhCG) within 1 week of RT administration or have a documented pregnancy test refusal. The effects of RT on the developing human fetus are harmful. For this reason and because RT used in this trial is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of RT administration. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of RT administration, and 4 months after completion of RT administration. Ability to understand and the willingness to sign a written informed consent document. Patients with bulky tumors (>7.5 cm) are allowed. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Exclusion Criteria: Patients with psychiatric illness/social situations that would limit compliance with study requirements. Pregnant women are excluded from this study because RT is an agent with the potential for teratogenic or abortifacient effects. Patients with other lymphoma diagnoses other than marginal zone lymphoma. Patients with a history of radiation to the treated site, if re-treatment would exceed known gastric or surrounding critical structure (e.g., bowel, spinal cord) tolerance. Patients with active scleroderma under treatment are ineligible as prior studies have shown excessive toxicity in scleroderma patients treated with RT.

Sites / Locations

  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultra Low Dose 4 Gy Radiation

Arm Description

Participants will receive the ultra-low doses of radiation therapy over 1-2 days

Outcomes

Primary Outcome Measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Secondary Outcome Measures

Full Information

First Posted
June 26, 2023
Last Updated
September 7, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05929612
Brief Title
A Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma
Official Title
A Phase II Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To learn if response-adapted, ultra-low dose radiation therapy can help to control MZL. This means participates first receive lower does of radiation therapy and then, based on how the disease responds, may receive higher doses after that.
Detailed Description
Primary Objectives: --To evaluate the efficacy of response adapted ultra low dose therapy (4 Gy with additional 12 Gy if needed) as a complete response after completion of the program Secondary Objectives: To evaluate distant recurrence of marginal zone lymphoma at 24 months To evaluate in field relapse at 24 months for all patients To evaluate the efficacy of response adapted ultra low dose therapy (4 Gy with additional 12 Gy if needed) as overall response rate (ORR) after completion of the program To evaluate overall survival of patients included in the study Exploratory Objectives: To determine if microbiome assessment can predict response to ultra low dose radiation therapy and evaluate the differences in patient microbiome for patients who respond well and poorly to low dose radiation. To encourage optional co-enrollment on study PA18-0644 to facilitate collection and archiving of blood-based biomarkers and microbiome samples for patients receiving ultra low dose radiation therapy. To evaluate PETCT-based features for any patients receive PETCT for initial and follow up assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultra Low Dose 4 Gy Radiation
Arm Type
Experimental
Arm Description
Participants will receive the ultra-low doses of radiation therapy over 1-2 days
Intervention Type
Radiation
Intervention Name(s)
Ultra Low Dose 4 Gy Radiation
Intervention Description
4 Gy in 2 fractions
Primary Outcome Measure Information:
Title
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time Frame
through study completion; an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years or older. Because no RT dosing data are currently available on the use of response adapted ultra low dose RT in patients <18 years of age, children are excluded from this study. Patients with stage I-II marginal zone lymphoma. Patients with a pathology report consistent with low grade B cell lymphoma, favor marginal zone lymphoma, are included. Other low grade lymphomas including follicular grade I/II and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible. Patients should not be planned for any systemic therapy before the first follow up evaluation after radiation (intent is to treat with radiation therapy alone). Patients with biopsy-proven disease treated with another modality (such as systemic therapy) prior to radiation must have clinical or radiographic evidence of residual disease before enrollment. Patients with clinical and/or radiographic masses that are measurable will have dimensions noted prior to therapy. If an excisional biopsy is performed, patients should have clinically or radiographically apparent disease after biopsy (this does not apply to gastric MALT lymphoma patients). Prior systemic therapy is allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy. There are no limits on the nature or amount of prior systemic therapy. Prior antibiotics intended to treat marginal zone lymphoma are allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy. Prior topical therapies (e.g. steroid) intended to treat cutaneous lymphoma are allowed, as long as administration is prior to most recent disease assessment by imaging, clinical exam, or endoscopy. For patients with gastric MALT lymphoma, H. pylori testing by immunohistochemistry on tissue biopsy is required on most recent pathologic specimen prior to protocol enrollment. Secondary testing for H. pylori with stool and/or urea breath tests and/or serum antigen is strongly recommended. Testing for the MALT1 translocation (t11:18) is strongly recommended if tissue for testing is available. Female patients with childbearing potential must have a negative serum or urine pregnancy test (βhCG) within 1 week of RT administration or have a documented pregnancy test refusal. The effects of RT on the developing human fetus are harmful. For this reason and because RT used in this trial is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of RT administration. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of RT administration, and 4 months after completion of RT administration. Ability to understand and the willingness to sign a written informed consent document. Patients with bulky tumors (>7.5 cm) are allowed. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Exclusion Criteria: Patients with psychiatric illness/social situations that would limit compliance with study requirements. Pregnant women are excluded from this study because RT is an agent with the potential for teratogenic or abortifacient effects. Patients with other lymphoma diagnoses other than marginal zone lymphoma. Patients with a history of radiation to the treated site, if re-treatment would exceed known gastric or surrounding critical structure (e.g., bowel, spinal cord) tolerance. Patients with active scleroderma under treatment are ineligible as prior studies have shown excessive toxicity in scleroderma patients treated with RT.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jillian Gunther, MD
Phone
(832) 710-7864
Email
jgunther@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jillian Gunther, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jillian Gunther, MD,PHD
Phone
832-710-7864
Email
jgunther@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Jillian Gunther, MD,PHD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

A Study of Response Adapted Ultra Low Dose 4 Gy Radiation for Definitive Therapy of Marginal Zone Lymphoma

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