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Treatment of Low-Grade Gastric Non-Hodgkin‘s Lymphoma of Mucosa-Associated Lymphoid Tissue (MALT) Type Stages IE & II1E (HELYX-Study)


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Lymphoma, Lymphoma, Non-Hodgkin

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Trial Information

Treatment of Low-Grade Gastric Non-Hodgkin‘s Lymphoma of Mucosa-Associated Lymphoid Tissue (MALT) Type Stages IE & II1E (HELYX-Study)


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.


Inclusion Criteria:



- 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

- sufficient renal function, defined as creatinine < 133µmol/l

- written informed consent

- complete clinical tumor staging

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

remission status after eradication therapy 3-monthly

Principal Investigator

Andrea Morgner-Miehlke, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Med. Dept. I, University Hospital, Technical University Dresden

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

HELYX Study

NCT ID:

NCT00154440

Start Date:

November 2001

Completion Date:

October 2013

Related Keywords:

  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell, Marginal Zone

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