LymphomaPhase 3NCT00154440
Helicobacter - Lymphoma - Radiation Part I: Eradication, Part II: Radiation
A Phase 3 study testing proton pump inhibitor, clarithromycin and amoxicillin in people with Lymphoma and Lymphoma, Non-Hodgkin, run by Technische Universität Dresden at 3 sites in Germany.
Trial summary
The first objective of this study is to confirm the results of complete remission of low-grade gastric MALT lymphoma stage IE \& II1E after H. pylori eradication on a larger number of patients (HELYX Part I). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma, Lymphoma, Non-Hodgkin
- What is being tested?
- proton pump inhibitor, clarithromycin and amoxicillin
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 3 sitesGermany
- Study dates
- Nov 2001to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically diagnosed, primary gastric low-grade B-cell MALT lymphoma stages IE or II1E, Helicobacter pylori-positive (in histology, urease test , and serology) for inclusion into HELYX part I
- histologically diagnosed, primary gastric low-grade B-cell MALT lymphoma stages IE or II1E, Helicobacter pylori-negative (in histology, urease test, and serology) for inclusion into HELYX part II
- patients who achieved a study end point of HELYX I: partial remission or no change 12 months after successful antibiotic therapy for inclusion into HELYX part II,
- age > 18 and < 75 years
- Karnofsky-Index > 60%
- sufficient liver function, defined as bilirubin < 34µmol/l
Show all 9Show fewer
- sufficient renal function, defined as creatinine < 133µmol/l
- written informed consent
- complete clinical tumor staging
Who cannot join
- primary gastric low-grade MALT lymphoma, stages >II1E or gastric high-grade lymphoma or other lymphoma entities of the stomach e.g. lymphoblastic lymphoma or Burkitt's lymphoma
- age < 18 and > 75 years
- Karnofsky-Index < 60%
- insufficient liver and renal function (see above)
- HIV-infection
- pregnancy or nursing
Trial locations and contacts
3 sites in 1 country.
Andrea Morgner-Miehlke, MD, PhD contact
Germany3 sites, 3 recruiting
- Recruiting
Institute for Pathology
Bayreuth, Bavaria, 95445
Manfred Stolte, MD, PhD, +49921400 ext. 5600, pathologie.klinikum@bnbt.de
Michael Vieth, MD, PhD, +49921400 ext. 5602, Vieth.LKPathol@uni-bayreuth.de
- Recruiting
Med. Dept. I, Gastroenterology
Dresden, Saxony, 01307
Gerhard Ehninger, MD, PhD, +49251458 ext. 4190, gerhard.ehninger@uniklinikum-dresden.de
Stephan Miehlke, MD, PhD, +49351458 ext. 5645, stephan.miehlke@uniklinikum-dresden.de
- Recruiting
Dept. for Radiation Therapy & Radiooncology, University Hospital
Germany, Saxony, 01307
Thomas Herrmann, MD, PhD, +49351458 ext. 3373, thomas.herrmann@uniklinikum-dresden.de
Monique Dawel, MD, +49351458 ext. 3373, monique.dawel@uniklinikum-dresden.de
About this study
Official title: Treatment of Low-Grade Gastric Non-Hodgkin's Lymphoma of Mucosa-Associated Lymphoid Tissue (MALT) Type Stages IE & II1E (HELYX-Study)
The first objective of this study is to confirm the results of complete remission of low-grade gastric MALT lymphoma stage IE \& II1E after H. pylori eradication on a larger number of patients (HELYX Part I). If there is no response to the antibiotic therapy, the role of radiotherapy on the course of gastric MALT lymphoma will be investigated as a consecutive therapeutic option for patients that are H. pylori- negative, t(11;18)-positive or failure candidates after eradication therapy. Furthermore, the method of radiation, and the radiation dose will be investigated and standardized. HELYX PART II is therefore a randomized equivalent study comparing the standard dose of 36Gy vs. a reduced dose of 25.2Gy locoregional. Additional molecular genetic analysis will be performed to try to understand pathogenetic mechanisms of lymphomagenesis.
Read the detailed description
Experimental data have extended the knowledge of the mere association of gastric MALT lymphoma and infection with Helicobacter pylori. If we summarise the reports to date on the results of treatment of gastric low-grade MALT lymphoma in an early clinical stage (EI) by H. pylori eradication we find a complete remission figure of 77% in more than 200 patients.
As a therapy with less side effects than radiation, surgery or chemotherapy and as a stomach-conserving treatment, eradication of H. pylori in patients with low-grade gastric MALT lymphoma in stages IE \& II1E should be the treatment of the choice within clinical trials since there are no long-term results available thus far. Besides, pretreatment patient selection and careful follow-up with endoscopy, biopsies and clinical staging including endoscopic ultrasonography is necessary. However, a five to ten year-follow-up will be necessary before the definitive value of Helicobacter pylori eradication can be established. Furthermore, since not all patients respond to this therapy research into the pathogenetic mechanisms of lymphomagenesis is inevitable.
Approximately 20% of patients with antigen-positive, primary gastric low-grade MALT lymphoma in stage I will not respond to eradication therapy. Hence, a consecutive salvage therapy other than surgery is much needed. The aim of the second part of this study is to establish radiation therapy as a salvage therapy. Furthermore, the effect of a reduced radiation dose (25.2Gy) compared to the standard dose (36Gy) will be investigated with the aim of non-inferiority of both doses.
- Conditions
- Lymphoma, Lymphoma, Non-Hodgkin
- Being tested
- proton pump inhibitor, clarithromycin, amoxicillin, metronidazole, radiation therapy
- Keywords
- primary gastric MALT lymphoma, Helicobacter pylori, eradication therapy, radiation, marginal zone B-cell lymphoma, Mucosa-associated Lymphoid Tissue, B-cell Non-Hodgkin's Lymphoma of the stomach, primary gastric lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Marginal Zone, Familial primary gastric lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton pump inhibitorDrug
clarithromycinDrug
amoxicillinDrug
metronidazoleDrug
radiation therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
remission status after eradication therapy 3-monthly
continuous complete remission (CCR) during follow-up
remission status after radiation therapy (36 Gy vs 25.2 Gy)
continuous complete remission after radiation therapy during follow-up
Secondary outcomes (4)
endoscopic controls every 3 months during the first year
endoscopic controls twice yearly in the second year after CR
complete tumor staging once yearly
relapse after therapy after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2001
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Andrea Morgner-Miehlke, MD, PhD, Principal investigator, Med. Dept. I, University Hospital, Technical University Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154440
- Sponsor's protocol ID
- HELYX Study
- Status last verified
- Mar 2007
- First submitted
- 8 Sep 2005
- Last updated
- 26 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Akagi T, Motegi M, Tamura A, Suzuki R, Hosokawa Y, Suzuki H, Ota H, Nakamura S, Morishima Y, Taniwaki M, Seto M. A novel gene, MALT1 at 18q21, is involved in t(11;18) (q21;q21) found in low-grade B-cell lymphoma of mucosa-associated lymphoid tissue. Oncogene. 1999 Oct 14;18(42):5785-94. doi: 10.1038/sj.onc.1203018.
PubMed 10523859Alpen B, Neubauer A, Dierlamm J, Marynen P, Thiede C, Bayerdorfer E, Stolte M. Translocation t(11;18) absent in early gastric marginal zone B-cell lymphoma of MALT type responding to eradication of Helicobacter pylori infection. Blood. 2000 Jun 15;95(12):4014-5. No abstract available.
PubMed 10939796Bayerdorffer E, Neubauer A, Rudolph B, Thiede C, Lehn N, Eidt S, Stolte M. Regression of primary gastric lymphoma of mucosa-associated lymphoid tissue type after cure of Helicobacter pylori infection. MALT Lymphoma Study Group. Lancet. 1995 Jun 24;345(8965):1591-4. doi: 10.1016/s0140-6736(95)90113-2.
PubMed 7783535Hussell T, Isaacson PG, Crabtree JE, Spencer J. The response of cells from low-grade B-cell gastric lymphomas of mucosa-associated lymphoid tissue to Helicobacter pylori. Lancet. 1993 Sep 4;342(8871):571-4. doi: 10.1016/0140-6736(93)91408-e.
PubMed 8102718Liu H, Ruskon-Fourmestraux A, Lavergne-Slove A, Ye H, Molina T, Bouhnik Y, Hamoudi RA, Diss TC, Dogan A, Megraud F, Rambaud JC, Du MQ, Isaacson PG. Resistance of t(11;18) positive gastric mucosa-associated lymphoid tissue lymphoma to Helicobacter pylori eradication therapy. Lancet. 2001 Jan 6;357(9249):39-40. doi: 10.1016/S0140-6736(00)03571-6.
PubMed 11197361Neubauer A, Thiede C, Morgner A, Alpen B, Ritter M, Neubauer B, Wundisch T, Ehninger G, Stolte M, Bayerdorffer E. Cure of Helicobacter pylori infection and duration of remission of low-grade gastric mucosa-associated lymphoid tissue lymphoma. J Natl Cancer Inst. 1997 Sep 17;89(18):1350-5. doi: 10.1093/jnci/89.18.1350.
PubMed 9308704Schechter NR, Portlock CS, Yahalom J. Treatment of mucosa-associated lymphoid tissue lymphoma of the stomach with radiation alone. J Clin Oncol. 1998 May;16(5):1916-21. doi: 10.1200/JCO.1998.16.5.1916.
PubMed 9586910Thiede C, Morgner A, Alpen B, Wundisch T, Herrmann J, Ritter M, Ehninger G, Stolte M, Bayerdorffer E, Neubauer A. What role does Helicobacter pylori eradication play in gastric MALT and gastric MALT lymphoma? Gastroenterology. 1997 Dec;113(6 Suppl):S61-4. doi: 10.1016/s0016-5085(97)80014-5.
PubMed 9394762Ruskone-Fourmestraux A, Dragosics B, Morgner A, Wotherspoon A, De Jong D. Paris staging system for primary gastrointestinal lymphomas. Gut. 2003 Jun;52(6):912-3. doi: 10.1136/gut.52.6.912. No abstract available.
PubMed 12740354Schmelz R, Miehlke S, Thiede C, Brueckner S, Dawel M, Kuhn M, Ruskone-Formestraux A, Stolte M, Jentsch C, Hampe J, Morgner A. Sequential H. pylori eradication and radiation therapy with reduced dose compared to standard dose for gastric MALT lymphoma stages IE & II1E: a prospective randomized trial. J Gastroenterol. 2019 May;54(5):388-395. doi: 10.1007/s00535-018-1517-4. Epub 2018 Oct 16.
PubMed 30327875
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Low-Grade Gastric Non-Hodgkin's Lymphoma of Mucosa-Associated Lymphoid Tissue (MALT) Type Stages IE & II1E (HELYX-Study)
- ClinicalTrials.gov ID
- NCT00154440
- Acronym / sponsor ID
- HELYX Study
- Conditions
- Lymphoma, Lymphoma, Non-Hodgkin
- Keywords
- primary gastric MALT lymphoma, Helicobacter pylori, eradication therapy, radiation, marginal zone B-cell lymphoma, Mucosa-associated Lymphoid Tissue, B-cell Non-Hodgkin's Lymphoma of the stomach, primary gastric lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Nov 2001
- Study completion
- Oct 2013 (estimated)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first objective of this study is to confirm the results of complete remission of low-grade gastric MALT lymphoma stage IE \& II1E after H. pylori eradication on a larger number of patients (HELYX Part I). If there is no response to the antibiotic therapy, the role of radiotherapy on the course of gastric MALT lymphoma will be investigated as a consecutive therapeutic option for patients that are H. pylori- negative, t(11;18)-positive or failure candidates after eradication therapy. Furthermore, the method of radiation, and the radiation dose will be investigated and standardized. HELYX PART II is therefore a randomized equivalent study comparing the standard dose of 36Gy vs. a reduced dose of 25.2Gy locoregional. Additional molecular genetic analysis will be performed to try to understand pathogenetic mechanisms of lymphomagenesis.
Detailed description
Experimental data have extended the knowledge of the mere association of gastric MALT lymphoma and infection with Helicobacter pylori. If we summarise the reports to date on the results of treatment of gastric low-grade MALT lymphoma in an early clinical stage (EI) by H. pylori eradication we find a complete remission figure of 77% in more than 200 patients.
As a therapy with less side effects than radiation, surgery or chemotherapy and as a stomach-conserving treatment, eradication of H. pylori in patients with low-grade gastric MALT lymphoma in stages IE \& II1E should be the treatment of the choice within clinical trials since there are no long-term results available thus far. Besides, pretreatment patient selection and careful follow-up with endoscopy, biopsies and clinical staging including endoscopic ultrasonography is necessary. However, a five to ten year-follow-up will be necessary before the definitive value of Helicobacter pylori eradication can be established. Furthermore, since not all patients respond to this therapy research into the pathogenetic mechanisms of lymphomagenesis is inevitable.
Approximately 20% of patients with antigen-positive, primary gastric low-grade MALT lymphoma in stage I will not respond to eradication therapy. Hence, a consecutive salvage therapy other than surgery is much needed. The aim of the second part of this study is to establish radiation therapy as a salvage therapy. Furthermore, the effect of a reduced radiation dose (25.2Gy) compared to the standard dose (36Gy) will be investigated with the aim of non-inferiority of both doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically diagnosed, primary gastric low-grade B-cell MALT lymphoma stages IE or II1E, Helicobacter pylori-positive (in histology, urease test , and serology) for inclusion into HELYX part I
- histologically diagnosed, primary gastric low-grade B-cell MALT lymphoma stages IE or II1E, Helicobacter pylori-negative (in histology, urease test, and serology) for inclusion into HELYX part II
- patients who achieved a study end point of HELYX I: partial remission or no change 12 months after successful antibiotic therapy for inclusion into HELYX part II,
- age > 18 and < 75 years
- Karnofsky-Index > 60%
Key exclusion criteria (6 listed)
- primary gastric low-grade MALT lymphoma, stages >II1E or gastric high-grade lymphoma or other lymphoma entities of the stomach e.g. lymphoblastic lymphoma or Burkitt's lymphoma
- age < 18 and > 75 years
- Karnofsky-Index < 60%
- insufficient liver and renal function (see above)
- HIV-infection
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 |
|---|---|---|
| proton pump inhibitor | Drug | – |
| clarithromycin | Drug | – |
| amoxicillin | Drug | – |
| metronidazole | Drug | – |
| radiation therapy | Procedure or surgery | – |
Primary outcome
remission status after eradication therapy 3-monthly
continuous complete remission (CCR) during follow-up
remission status after radiation therapy (36 Gy vs 25.2 Gy)
continuous complete remission after radiation therapy during follow-up
4 secondary outcomes
endoscopic controls every 3 months during the first year
endoscopic controls twice yearly in the second year after CR
complete tumor staging once yearly
relapse after therapy after each intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2007.
- Background: PubMed 10523859Akagi T, Motegi M, Tamura A, Suzuki R, Hosokawa Y, Suzuki H, Ota H, Nakamura S, Morishima Y, Taniwaki M, Seto M. A novel gene, MALT1 at 18q21, is involved in t(11;18) (q21;q21) found in low-grade B-cell lymphoma of mucosa-associated lymphoid tissue. Oncogene. 1999 Oct 14;18(42):5785-94. doi: 10.1038/sj.onc.1203018.
- Background: PubMed 10939796Alpen B, Neubauer A, Dierlamm J, Marynen P, Thiede C, Bayerdorfer E, Stolte M. Translocation t(11;18) absent in early gastric marginal zone B-cell lymphoma of MALT type responding to eradication of Helicobacter pylori infection. Blood. 2000 Jun 15;95(12):4014-5. No abstract available.
- Background: PubMed 7783535Bayerdorffer E, Neubauer A, Rudolph B, Thiede C, Lehn N, Eidt S, Stolte M. Regression of primary gastric lymphoma of mucosa-associated lymphoid tissue type after cure of Helicobacter pylori infection. MALT Lymphoma Study Group. Lancet. 1995 Jun 24;345(8965):1591-4. doi: 10.1016/s0140-6736(95)90113-2.
- Background: PubMed 8102718Hussell T, Isaacson PG, Crabtree JE, Spencer J. The response of cells from low-grade B-cell gastric lymphomas of mucosa-associated lymphoid tissue to Helicobacter pylori. Lancet. 1993 Sep 4;342(8871):571-4. doi: 10.1016/0140-6736(93)91408-e.
- Background: PubMed 11197361Liu H, Ruskon-Fourmestraux A, Lavergne-Slove A, Ye H, Molina T, Bouhnik Y, Hamoudi RA, Diss TC, Dogan A, Megraud F, Rambaud JC, Du MQ, Isaacson PG. Resistance of t(11;18) positive gastric mucosa-associated lymphoid tissue lymphoma to Helicobacter pylori eradication therapy. Lancet. 2001 Jan 6;357(9249):39-40. doi: 10.1016/S0140-6736(00)03571-6.
- Background: PubMed 9308704Neubauer A, Thiede C, Morgner A, Alpen B, Ritter M, Neubauer B, Wundisch T, Ehninger G, Stolte M, Bayerdorffer E. Cure of Helicobacter pylori infection and duration of remission of low-grade gastric mucosa-associated lymphoid tissue lymphoma. J Natl Cancer Inst. 1997 Sep 17;89(18):1350-5. doi: 10.1093/jnci/89.18.1350.
- Background: PubMed 9586910Schechter NR, Portlock CS, Yahalom J. Treatment of mucosa-associated lymphoid tissue lymphoma of the stomach with radiation alone. J Clin Oncol. 1998 May;16(5):1916-21. doi: 10.1200/JCO.1998.16.5.1916.
- Background: PubMed 9394762Thiede C, Morgner A, Alpen B, Wundisch T, Herrmann J, Ritter M, Ehninger G, Stolte M, Bayerdorffer E, Neubauer A. What role does Helicobacter pylori eradication play in gastric MALT and gastric MALT lymphoma? Gastroenterology. 1997 Dec;113(6 Suppl):S61-4. doi: 10.1016/s0016-5085(97)80014-5.
- Background: PubMed 12740354Ruskone-Fourmestraux A, Dragosics B, Morgner A, Wotherspoon A, De Jong D. Paris staging system for primary gastrointestinal lymphomas. Gut. 2003 Jun;52(6):912-3. doi: 10.1136/gut.52.6.912. No abstract available.
- Derived from this study: PubMed 30327875Schmelz R, Miehlke S, Thiede C, Brueckner S, Dawel M, Kuhn M, Ruskone-Formestraux A, Stolte M, Jentsch C, Hampe J, Morgner A. Sequential H. pylori eradication and radiation therapy with reduced dose compared to standard dose for gastric MALT lymphoma stages IE & II1E: a prospective randomized trial. J Gastroenterol. 2019 May;54(5):388-395. doi: 10.1007/s00535-018-1517-4. Epub 2018 Oct 16.
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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.
Andrea Morgner-Miehlke, MD, PhD contact
Andrea Morgner-Miehlke, MD, PhD principal investigator
Med. Dept. I, University Hospital, Technical University Dresden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing proton pump inhibitor, clarithromycin and amoxicillin in people with Lymphoma and Lymphoma, Non-Hodgkin, run by Technische Universität Dresden at 3 sites in Germany.
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 9 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: status not confirmed, as of the sponsor's last update on 26 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Morgner-Miehlke, MD, PhD (+49351458 ext. 2986, andrea.morgner-miehlke@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission status after eradication therapy 3-monthly. The study lists 4 primary outcomes in all. 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 NCT00154440, which also lists 10 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 26 Mar 2007.