Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissuePhase 2NCT04465162
Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
A Phase 2 study testing Radiation Therapy in people with Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue and Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies the side effects of radiation therapy used alone, and if it can achieve a high cure rate in the treatment of patients with MALT lymphoma. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors. This treatment may improve the patient's lymphoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Extranodal Marginal Zone Lymphoma
- What is being tested?
- Radiation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2000to 15 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with newly diagnosed stage 1 and 2 MALT lymphoma are eligible for this study
- Patients with Helicobacter (H.) pylori positive gastric MALT lymphoma are recommended to have treatments with antibiotics prior to enrollment to this protocol
- Patients who failed other treatment modalities (e.g. chemotherapy, antibiotics therapy etc) are also eligible as far as they never had stage 3 or 4 disease during the course of the disease or disease progression to the opposite side of the diaphragm (as the time course of the response to antibiotic therapy can be very variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic therapy can be very variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic treatment will be defined as no response or progression of the disease documented by endoscopy and biopsy)
- Patients who have had stage 4 diseases due to bilateral parotid gland or ocular/ocular adnexal involvement or due to multiple sites within Waldeyer's ring will still be eligible
Who cannot join
- Patients who had previous radiation dose to the site of the current primary disease which would lead to violation of known radiation tolerance limit of that particular site if treated again
- Patients with MALT lymphoma of the skin whose lesions are separated by more than 5 cm will be ineligible
- Previous or concurrent malignancy in any form would not be an exclusion criterion. However, patients who receive chemotherapy for concurrent malignancy will be excluded from statistical analysis
- Low blood cell counts would not be exclusion criteria as far as the patient is willing to accept supportive measures such as transfusions, filgrastim and epoetin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiation Therapy Alone for Stage 1 and 2 MALT (Mucosa-Associated Lymphoid Tissue) Lymphoma
This trial studies the side effects of radiation therapy used alone, and if it can achieve a high cure rate in the treatment of patients with MALT lymphoma. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors. This treatment may improve the patient's lymphoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy and toxicity of radiation therapy alone in treating stage 1 and 2 MALT lymphoma for newly diagnosed patients and for the patients who failed other treatment modalities.
OUTLINE:
Patients undergo radiation therapy once daily (QD) 5 times weekly over 3.5-5 weeks.
After completion of study treatment, patients are followed up at 6-8 weeks, and then every 3-4 months for year 1, every 4-6 months for year 2, every 6 months for years 3 and 4, and once yearly thereafter.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyOther
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (radiation therapy) | Experimental | Patients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. Receives: Other: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free Survival (RFS)
RFS was defined as the time in months from the date of study entry until the last follow-up or death, with all deaths censored. Kaplan-Meier curves were estimated for the survival distributions.
Measured: Through study completion, up to 10 years
Secondary outcomes (3)
Median Progression Free Survival (PFS)
PFS is defined as the time from randomization to progression or death. Kaplan-Meier curves were estimated for the survival distributions.
Measured: 17.5 years
Progression Free Survival (PFS) at 10 Years
PFS events is the time in months and defined as any lymphoma relapse ( lymphoma that comes back after successful treatment and a period of remission) or death from any cause. Kaplan-Meier curves were estimated for the survival distributions.
Measured: Through study completion, up to 10 years
10 Year Overall Survival (OS)
Overall Survival is the time in months from start of study treatment to date of death due to any cause. Overall survival rates are estimated by the Kaplan-Meier method.
Measured: Through study completion, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start7 Jun 2000
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissueStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bouthaina S Dabaja, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465162
- Sponsor's protocol ID
- ID99-384
- Other IDs
- NCI-2020-02549, ID99-384
- Status last verified
- Feb 2022
- First submitted
- 6 May 2020
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fang P, Gunther JR, Pinnix CC, Dong W, Strati P, Nastoupil LJ, Steiner RE, Ahmed S, Damron EP, Fowler N, Nair R, Westin JR, Neelapu S, Ha CS, Dabaja BS. A Prospective Trial of Radiation Therapy Efficacy and Toxicity for Localized Mucosa-associated Lymphoid Tissue (MALT) Lymphoma. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1414-1420. doi: 10.1016/j.ijrobp.2020.11.070. Epub 2020 Dec 10.
PubMed 33309978
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy Alone for Stage 1 and 2 MALT (Mucosa-Associated Lymphoid Tissue) Lymphoma
- ClinicalTrials.gov ID
- NCT04465162
- Acronym / sponsor ID
- ID99-384
- Conditions
- Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Extranodal Marginal Zone Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jun 2000 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies the side effects of radiation therapy used alone, and if it can achieve a high cure rate in the treatment of patients with MALT lymphoma. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors. This treatment may improve the patient's lymphoma.
Detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy and toxicity of radiation therapy alone in treating stage 1 and 2 MALT lymphoma for newly diagnosed patients and for the patients who failed other treatment modalities.
OUTLINE:
Patients undergo radiation therapy once daily (QD) 5 times weekly over 3.5-5 weeks.
After completion of study treatment, patients are followed up at 6-8 weeks, and then every 3-4 months for year 1, every 4-6 months for year 2, every 6 months for years 3 and 4, and once yearly thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (radiation therapy) | Experimental | Other: Radiation TherapyPatients undergo radiation therapy QD 5 times weekly over 3.5-5 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with newly diagnosed stage 1 and 2 MALT lymphoma are eligible for this study
- Patients with Helicobacter (H.) pylori positive gastric MALT lymphoma are recommended to have treatments with antibiotics prior to enrollment to this protocol
- Patients who failed other treatment modalities (e.g. chemotherapy, antibiotics therapy etc) are also eligible as far as they never had stage 3 or 4 disease during the course of the disease or disease progression to the opposite side of the diaphragm (as the time course of the response to antibiotic therapy can be very variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic therapy can be very variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic treatment will be defined as no response or progression of the disease documented by endoscopy and biopsy)
- Patients who have had stage 4 diseases due to bilateral parotid gland or ocular/ocular adnexal involvement or due to multiple sites within Waldeyer's ring will still be eligible
Key exclusion criteria (4 listed)
- Patients who had previous radiation dose to the site of the current primary disease which would lead to violation of known radiation tolerance limit of that particular site if treated again
- Patients with MALT lymphoma of the skin whose lesions are separated by more than 5 cm will be ineligible
- Previous or concurrent malignancy in any form would not be an exclusion criterion. However, patients who receive chemotherapy for concurrent malignancy will be excluded from statistical analysis
- Low blood cell counts would not be exclusion criteria as far as the patient is willing to accept supportive measures such as transfusions, filgrastim and epoetin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, IrradiationUndergo radiation therapy | Other | Treatment (radiation therapy) |
Primary outcome
Relapse-free Survival (RFS)
Time frame: Through study completion, up to 10 years
RFS was defined as the time in months from the date of study entry until the last follow-up or death, with all deaths censored. Kaplan-Meier curves were estimated for the survival distributions.
3 secondary outcomes
Median Progression Free Survival (PFS)
Time frame: 17.5 years
Progression Free Survival (PFS) at 10 Years
Time frame: Through study completion, up to 10 years
10 Year Overall Survival (OS)
Time frame: Through study completion, up to 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33309978Fang P, Gunther JR, Pinnix CC, Dong W, Strati P, Nastoupil LJ, Steiner RE, Ahmed S, Damron EP, Fowler N, Nair R, Westin JR, Neelapu S, Ha CS, Dabaja BS. A Prospective Trial of Radiation Therapy Efficacy and Toxicity for Localized Mucosa-associated Lymphoid Tissue (MALT) Lymphoma. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1414-1420. doi: 10.1016/j.ijrobp.2020.11.070. Epub 2020 Dec 10.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bouthaina S Dabaja principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation Therapy in people with Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue and Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, run by M.D. Anderson Cancer Center at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 2 Mar 2022. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Relapse-free Survival (RFS) (time frame: Through study completion, up to 10 years). 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 NCT04465162, which also lists 1 linked publication.
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 2 Mar 2022.