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Primary Indolent Cutaneous B-cell LymphomaLDRTNCT07310745

Low Dose Radiotherapy in Primary Indolent Cutaneous B-cell Lymphoma

An observational study of Primary Indolent Cutaneous B-cell Lymphoma, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

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

Primary indolent cutaneous B cell lymphomas (PCBCL) are rare: although data on outcomes and treatment are limited, traditionally they have been treated with radiation doses in excess of 24 Gy. Read more about this study

Who is it for?
Ages 18 years and older
How many people
52 participants
Where
1 siteItaly
Study dates
18 Dec 2025to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: The study involves adult patients with early-stage (I-II) primary cutaneous indolent B-cell lymphoma (PCBCL) treated with low-dose radiotherapy (4 Gy in two sessions). Patients with a confirmed histological diagnosis of indolent B-cell lymphoma (follicular, marginal, NOS) and adequate follow-up are included. Patients with aggressive lymphomas, advanced stages, extracutaneous localisations or radiotherapy doses greater than 4 Gy are excluded.

Who may be able to join

  • Age greater than or equal to 18 years
  • Histological diagnosis of indolent B-cell lymphoma (follicular, marginal, NOS)
  • Primary cutaneous location
  • Early stage (I-II)
  • First diagnosis or recurrence
  • Low-dose radiotherapy treatment (4 Gy/2 sessions)

Who cannot join

  • Aggressive histology lymphomas
  • Advanced stages
  • Extracutaneous localisation
  • Radiotherapy dose administered > 4 Gy
  • Patients without histological typing
  • Patients without follow-up

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda USL IRCCS di Reggio Emilia - Sc Radioterapia

    Reggio Emilia

Other trials in Italy

About this study

Primary indolent cutaneous B cell lymphomas (PCBCL) are rare: although data on outcomes and treatment are limited, traditionally they have been treated with radiation doses in excess of 24 Gy. Recently, some trials that patients with primary cutaneous indolent lymphoma managed with very low dose (4 Gy) RT (LDRT) have shown that high response rates and durable remission can be achieved; unfortunately, given the retrospective nature of these studies, the role of LDRT in indolent PMCL remains undefined. The objective of this retrospective multicentric trial is to investigate the efficacy of low-dose involved-field radiation therapy in patients with primary indolent cutaneous B-cell Lymphoma.

Read the detailed description

Primary cutaneous B-cell lymphomas (PCBCL) represent approximately 20% of all primary cutaneous lymphoma and are defined by a restricted disease spread to the skin without evidence of extracutaneous involvement at diagnosis. They encompass three main types: primary cutaneous marginal zone lymphoma (PCMZL), primary cutaneous follicle center lymphoma (PCFCL) and primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL, LT), of which the first two entities are indolent. Radiotherapy (RT) is part of the therapeutic mosaic for PCBCL and recommended by both national and international guidelines for a localized disease pattern, conferring high local control rates with a conservative approach . Curative doses cover a range of 18-54 Gy and complete remission is common regardless of which treatment is used. There is accumulating evidence for a possible de-escalation of RT dose while maintaining high response rates and thereby opening a role for low-dose RT (LDRT), which has been successfully shown for other indolent non-Hodgkin lymphoma. However, the rarity of indolent PCBCL and retrospective nature of studies make a definitive dose recommendation troublesome.

Keywords
Primary indolent cutaneous B-cell Lymphoma, Low dose RT, Primary cutaneous marginal zone lymphoma

What is being measured

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

  1. Local Progression-Free Interval in Irradiated Field

    Time from the start of low dose radiotherapy (LDRT) to tumor progression within the irradiated field

    Measured: 12 months

Secondary outcomes (6)

  1. Acute toxicity

    The occurence and severity of acute adverse events (toxicities)

    Measured: 4 weeks

  2. Late toxicity

    The occurrence and severity of late adverse events (toxicities)

    Measured: 12 weeks

  3. Tumor response in irradated area

    The response of the tumor in the irradiated area will be evaluated based on radiological imaging and/or clinical examination

    Measured: 12 weeks

  4. Overall response rate (ORR)

    The overall response rate is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) in the irradiated sites, as assessed by the investigator using the Lugano classification criteria.

    Measured: 12 weeks

  5. Overall survival (OS)

    Overall Survival (OS) is defined as the time from the start of LDRT to the date of death from any cause.

    Measured: 24 months

  6. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) is defined as the time from the start of Low Dose Radiotherapy (LDRT) to the first observation of disease progression or relapse, or the date of the last follow-up if no progression is observed

    Measured: 24 months

Timeline

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

  1. First posted30 Dec 2025
  2. Study start18 Dec 2025
  3. Primary completion18 Dec 2025
  4. Study completionDec 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07310745
Sponsor's protocol ID
263/2022/OSS/IRCCSRE
Acronym
LDRT
Status last verified
Dec 2025
First submitted
16 Dec 2025
Last updated
23 Apr 2026
Results posted
No

Publications

  • Christensen L, Cooper K, Honda K, Mansur D. Relapse rates in patients with unilesional primary cutaneous B-cell lymphoma treated with radiation therapy: a single-institution experience. Br J Dermatol. 2018 Nov;179(5):1172-1173. doi: 10.1111/bjd.16783. Epub 2018 Jul 27. No abstract available.

    PubMed 29761874

  • Senff NJ, Noordijk EM, Kim YH, Bagot M, Berti E, Cerroni L, Dummer R, Duvic M, Hoppe RT, Pimpinelli N, Rosen ST, Vermeer MH, Whittaker S, Willemze R; European Organization for Research and Treatment of Cancer; International Society for Cutaneous Lymphoma. European Organization for Research and Treatment of Cancer and International Society for Cutaneous Lymphoma consensus recommendations for the management of cutaneous B-cell lymphomas. Blood. 2008 Sep 1;112(5):1600-9. doi: 10.1182/blood-2008-04-152850. Epub 2008 Jun 20.

    PubMed 18567836

  • Willemze R, Cerroni L, Kempf W, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714. Blood. 2019 Sep 26;134(13):1112. doi: 10.1182/blood.2019002852. No abstract available.

    PubMed 31558559

  • Willemze R, Hodak E, Zinzani PL, Specht L, Ladetto M; ESMO Guidelines Committee. Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv30-iv40. doi: 10.1093/annonc/mdy133. No abstract available.

    PubMed 29878045

  • Nicolay JP, Wobser M. Cutaneous B-cell lymphomas - pathogenesis, diagnostic workup, and therapy. J Dtsch Dermatol Ges. 2016 Dec;14(12):1207-1224. doi: 10.1111/ddg.13164.

    PubMed 27992127

  • Dippel E, Assaf C, Becker JC, von Bergwelt-Baildon M, Beyer M, Cozzio A, Eich HT, Follmann M, Grabbe S, Hillen U, Klapper W, Klemke CD, Lamos C, Loquai C, Meiss F, Mestel D, Nashan D, Nicolay JP, Oschlies I, Schlaak M, Stoll C, Vag T, Weichenthal M, Wobser M, Stadler R. S2k Guidelines - Cutaneous Lymphomas Update 2016 - Part 1: Classification and Diagnosis (ICD10 C82 - C86). J Dtsch Dermatol Ges. 2017 Dec;15(12):1266-1273. doi: 10.1111/ddg.13372. Epub 2017 Nov 28. No abstract available.

    PubMed 29193659

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Indolent Cutaneous B-cell Lymphoma, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Progression-Free Interval in Irradiated Field (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07310745, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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