NCT02494700

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

Active, enrolled Phase 2 Last updated 7 January 2026

What this trial tests

Phase 2 trial testing External Beam Radiation Therapy in Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 July 2015

Primary endpoint
30 June 2027

30 June 2027

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	6 July 2015
Primary completion	30 June 2027
Estimated completion	30 June 2027
Sites	1 location across United States

Drugs / interventions tested

• External Beam Radiation Therapy
• Orbital Radiation — full drug profile →

Conditions studied

• Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma — all drugs for Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma →
• Ann Arbor Stage I Grade 1 Follicular Lymphoma — all drugs for Ann Arbor Stage I Grade 1 Follicular Lymphoma →
• Ann Arbor Stage I Grade 2 Follicular Lymphoma — all drugs for Ann Arbor Stage I Grade 2 Follicular Lymphoma →
• Ann Arbor Stage I Indolent Adult Non-Hodgkin Lymphoma — all drugs for Ann Arbor Stage I Indolent Adult Non-Hodgkin Lymphoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma or Ann Arbor Stage I Grade 1 Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ultra-low-dose radiotherapy for definitive management of ocular adnexal B-cell lymphoma.
   Pinnix CC, Dabaja BS, Milgrom SA, Smith GL, et al · · 2017 · cited 68× · PMID 28370694 · DOI 10.1002/hed.24717
2. Response-Adapted Ultralow-Dose Radiation Therapy for Orbital Indolent B-Cell Lymphoma: A Phase 2 Nonrandomized Controlled Trial.
   Pinnix CC, Dabaja BS, Gunther JR, Fang PQ, et al · · 2024 · cited 12× · PMID 38990564 · DOI 10.1001/jamaoncol.2024.2112
3. Efficacy of low-dose radiotherapy (2 Gy × 2) in the treatment of marginal zone and mucosa-associated lymphoid tissue lymphomas.
   Cerrato M, Orlandi E, Vella A, Bartoncini S, et al · · 2021 · cited 11× · PMID 34111959 · DOI 10.1259/bjr.20210012
4. A Prospective Trial of Radiation Therapy Efficacy and Toxicity for Localized Mucosa-associated Lymphoid Tissue (MALT) Lymphoma.
   Fang P, Gunther JR, Pinnix CC, Dong W, et al · · 2021 · cited 11× · PMID 33309978 · DOI 10.1016/j.ijrobp.2020.11.070
5. Ultra-low dose radiotherapy in the management of low-grade orbital lymphomas.
   de Castro B, Peixeiro RP, Mariz JM, Oliveira Â. · · 2022 · cited 5× · PMID 36186691 · DOI 10.5603/rpor.a2022.0044
6. Two rare cases of bronchus-associated lymphoid tissue lymphoma successfully treated with rituximab-bendamustine.
   Panitz N, Gerhardt K, Becker C, Schleife H, et al · · 2021 · cited 2× · PMID 34401153 · DOI 10.1002/ccr3.4557