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Ann Arbor Stage I B-Cell Non-Hodgkin LymphomaPhase 2NCT02494700

Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma

A Phase 2 study testing External Beam Radiation Therapy and Orbital Radiation in people with Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma and Ann Arbor Stage I Grade 1 Follicular Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This phase II trial studies how well ultra low dose orbital radiation therapy works in treating patients with stage I-IV low grade (indolent) B-cell lymphoma or mantle cell lymphoma involving the orbit of the eye (space enclosed by the borders of the eye socket). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
External Beam Radiation Therapy and Orbital Radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
6 Jul 2015to 30 Jun 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18 years or older with stage I-IV indolent B cell lymphoma, including MALT and follicular grade I/II. Patients with mantle cell lymphoma will also be included in this study, as mantle cell lymphoma is also radiosensitive, despite it not being an indolent B cell lymphoma. Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible.
  • Patients must have measurable disease within the orbit, either clinically and/or radiographically after biopsy confirmation of B cell lymphoma.
  • Bilateral ocular adnexal involvement is permitted, if biopsy confirms unilateral disease and there is high clinical suspicion for bilateral disease, biopsy of the contralateral ocular adnexa can be waived.
  • Female patients of childbearing potential must have a negative serum pregnancy test (βhCG) within 2 weeks of protocol entry.
  • Planned systemic therapy after orbital radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of adjuvant systemic therapy.
  • Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
  • Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post-menopausal (free from menses > two years or surgically sterilized).
  • Patients must have the ability to give informed consent.

Who cannot join

  • Patients treated with chemotherapy for lymphoma within 4 weeks of protocol enrollment (including Rituxan).
  • Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma.
  • Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
  • Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance.
  • Patients with pre-existing retinopathy.
  • Patients who are pregnant.
  • Patients with active lupus or scleroderma are ineligible

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma

This phase II trial studies how well ultra low dose orbital radiation therapy works in treating patients with stage I-IV low grade (indolent) B-cell lymphoma or mantle cell lymphoma involving the orbit of the eye (space enclosed by the borders of the eye socket). Orbital radiation therapy uses external beam radiation to destroy cancer cells. Using ultra low dose orbital radiation therapy may be effective in treating indolent B-cell lymphoma or mantle cell lymphoma involving the eye and may have fewer side effects.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the efficacy of ultra low dose 4 Gray (Gy) orbital radiation, measured as local orbital control (i.e. local control within the radiation field), in patients with limited and advanced stage low grade B lymphocyte (B cell) lymphoma and mantle cell lymphoma involving the ocular adnexa.

II. To evaluate the efficacy of ultra low dose 4 Gy orbital radiation, measured as complete response, in patients with limited and advanced stage low grade B cell lymphoma and mantle cell lymphoma involving the ocular adnexa.

III. To evaluate the acute and chronic toxicity of radiation to the orbit.

SECONDARY OBJECTIVE:

  1. To determine if dynamic contrast enhanced magnetic resonance imaging can predict response to ultra low dose radiation therapy.

OUTLINE:

Patients undergo low dose orbital external beam radiation therapy (EBRT) on 2 consecutive days. Patients experiencing stable or progressive disease after 12-16 weeks of EBRT undergo additional low dose orbital EBRT over 10 fractions. Patients experiencing partial response or minimal response 1 year after EBRT also undergo low dose orbital EBRT over 10 fractions.

After completion of study treatment, patients are followed up every 3-4 months for 6-8 months, every 6-12 months for up to 2 years, and then periodically thereafter.

Being tested
External Beam Radiation Therapy, Orbital Radiation
Medical subject headings
Orbital lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External Beam Radiation TherapyRadiation

    Also called Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RT

    Undergo orbital EBRT

  • Orbital RadiationDrug

    Also called XRT

    Participants receive radiation to entire involved orbit for a total dose of 4 Gy in 2 fractions over two consecutive days with external beam radiotherapy. If there is stable disease or progressive disease, an additional 20 Gy administered to involved site. If there are two consecutive evaluations with no change in disease burden then an additional 20 Gy administered. At one year if there is persistent disease, an additional 20 Gy administered to involved site.

Study groups in NCT02494700
Study groupRoleWhat they receive
Treatment (low dose orbital EBRT)ExperimentalPatients undergo two fractions of low dose orbital EBRT on 2 consecutive days. Patients experiencing stable or progressive disease after 12-16 weeks of EBRT undergo additional low dose orbital EBRT over 10 fractions. Patients experiencing partial response or minimal response 1 year after EBRT also undergo low dose orbital EBRT over 10 fractions.
Receives: Radiation: External Beam Radiation Therapy; Drug: Orbital Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local orbital control (i.e. local control within the radiation field)

    Local orbital event will be estimated using the Kaplan-Meier method.

    Measured: Up to 2 years post-radiation

Secondary outcomes (5)

  1. Complete response rate

    Response rate will be estimated along with 95% confidence intervals.

    Measured: Up to 2 years

  2. Local regional control (i.e. local control within the ipsilateral orbit but outside of the radiation field)

    Measured: Up to 2 years post-radiation therapy

  3. Overall survival (OS)

    OS will be estimated using the Kaplan-Meier method.

    Measured: Up to 2 years

  4. Freedom from distant relapse rates

    Measured: Up to 2 years

  5. Incidence of acute and chronic ocular toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

    Toxicity data will be summarized by frequency tables.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2015 (estimated)
  2. Study start6 Jul 2015
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02494700
Sponsor's protocol ID
2014-1046
Other IDs
NCI-2015-01203, 2014-1046
Status last verified
Jul 2026
First submitted
8 Jul 2015
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Pinnix CC, Dabaja BS, Gunther JR, Fang PQ, Wu SY, Nastoupil LJ, Strati P, Nair R, Ahmed S, Steiner R, Westin J, Neelapu S, Rodriguez MA, Lee HJ, Wang M, Flowers C, Feng L, Esmaeli B. Response-Adapted Ultralow-Dose Radiation Therapy for Orbital Indolent B-Cell Lymphoma: A Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. 2024 Sep 1;10(9):1195-1203. doi: 10.1001/jamaoncol.2024.2112.

    PubMed 38990564

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