A scientific study on the cellular and genetic effect of the treatment used for malignant lymphomas.

Preclinical phase 0 micro dose study to evaluate the effekt of R-CHOP chemotherapy on cellular gene-expression. - Establisment of a preclinical model for in vivo evaluation of molecular biological efects. - R-CHOP phase 0

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002677-30-DK

Enrollment

Registered

2011-08-09

Start date

2011-08-29

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma, Mantlecell Lymphoma, Follicular Lymphoma, Primary Mediastinal Lymphoma, B-CLL if Rituximab is used as part of treatment. MedDRA version: 18.0 Level: LLT Classification code 10012820 Term: Diffuse large B-cell lymphoma NOS System Organ Class: 100000004864 MedDRA version: 18.0 Level: LLT Classification code 10036712 Term: Primary mediastinal large B-cell lymphoma NOS System Organ Class: 100000004864 MedDRA version: 18.0 Level: LLT Classification code 10008976 Term

Interventions

Trade Name: MabThera (Rituximab) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Any patient who have 1) planned treatment with R-CHOP or different R-chemotherapy for a haematologic disease in accordance with current guidelines at Aalborg Hospital. 2) age above 18 yrs. 3) ability to undestand and will to sign the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42

Exclusion criteria

Exclusion criteria: Any patient who 1) due to adverse reactions have their regular treatment cancelled.

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish a clinical method for phase 0 studies with the combination chemotherapy R-CHOP as focal-point. ;Secondary Objective: To identify a genetic profile of genes that are up- or down regulated during R-CHOP treatment, and through these data identify specific pathways for each drug individually and and for the entire combinationtherapy. On a long term, to verify results from this with other studies and identify genetic biomarkers-index, whic can be used to predict how an individual patient reponds to R-CHOP. ;Primary end point(s): Establish a clinical method for a phase 0 trial with tha combination therapy R-CHOP as the focal-point.;Timepoint(s) of evaluation of this end point: Before 01.12.2016.	—

Measure

Time frame

Main Objective: To establish a clinical method for phase 0 studies with the combination chemotherapy R-CHOP as focal-point. ;Secondary Objective: To identify a genetic profile of genes that are up- or down regulated during R-CHOP treatment, and through these data identify specific pathways for each drug individually and and for the entire combinationtherapy. On a long term, to verify results from this with other studies and identify genetic biomarkers-index, whic can be used to predict how an individual patient reponds to R-CHOP. ;Primary end point(s): Establish a clinical method for a phase 0 trial with tha combination therapy R-CHOP as the focal-point.;Timepoint(s) of evaluation of this end point: Before 01.12.2016.

—

Secondary

Measure	Time frame
Secondary end point(s): To identify a genetic profile of genes that are up- or down regulated during R-CHOP treatment, and through these data identify specific pathways for each drug individually and and for the entire combinationtherapy. Further, to identify genetic markers that can predict how an individual patient reponds to R-CHOP. ;Timepoint(s) of evaluation of this end point: Before 01.12.2016.	—

Measure

Time frame

Secondary end point(s): To identify a genetic profile of genes that are up- or down regulated during R-CHOP treatment, and through these data identify specific pathways for each drug individually and and for the entire combinationtherapy. Further, to identify genetic markers that can predict how an individual patient reponds to R-CHOP. ;Timepoint(s) of evaluation of this end point: Before 01.12.2016.

—

Countries

Denmark

Contacts

Public ContactHæmatologisk Forskningsafsnit

Professor Hans Erik Johnsen, MD, DMSc, Department of Haematology, Aalborg Hospital

lit@rn.dk4597663869

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026