Know Cancer

or
forgot password

Prospective, Open-label, Multicentric, ph. II Study of R-GemOx and Dexametasone in Patients With Agressive Lymphomas Refractory or Relapsed to Previous Treatment and Non Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplanted


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Aggressive Lymphoma, Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma

Thank you

Trial Information

Prospective, Open-label, Multicentric, ph. II Study of R-GemOx and Dexametasone in Patients With Agressive Lymphomas Refractory or Relapsed to Previous Treatment and Non Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplanted


The purpose of this study is to determine efficacy (overall response rate (ORR) and complete
response) tolerance and toxicity of rituximab, gemcitabine, oxaliplatin and dexametasone
(R-GemOx) chemotherapy schedule.


Inclusion Criteria:



1. Age ≥ 18 years.

2. DLBCL and MCL diagnosed patients in primary resistance or relapsed not eligible for
intensification chemotherapy followed by Autologous stem cell transplantation (ASCT)
for age, comorbidity or previous ASCT.

3. Any IPI or ECOG, capable of understanding the nature of the trial.

4. Writtern Informed Consent.

Exclusion Criteria:

1. Nursing pregnant or lactation period women, or fertile age adults not using
effective contraceptive method.

2. CNS lymphoma patients.

3. Patients with severa renal (creatinine> 2,5 UNL) or hepatic (Bilirrubin or ALT/AST>
2,5 UNL) impairement not provided by the same disease

4. HIV positive patients.

5. Serious psychiatric diseases patients that could interfere with their skill to
understand the study (including alcoholism or drug addiction).

6. Murine proteins or any other component of the medicines of the study hypersensitivity
patients.

7. Patients who have received more than 2 therapeutic previous lines. (for previous ASCT
patients, induction and conditioning for the TAPH treatment is considered a single
line therapy).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary endpoint is to evaluate Overall response rate (ORR)

Outcome Description:

The primary endpoint is to evaluate the number of patients with complete remission, unconfirmed complete remission and partial response according to International Workshop to Standardize Response Criteria for NHL, of R-GEMOX combination administered every 14 days

Outcome Time Frame:

3 years and 2 months

Safety Issue:

No

Principal Investigator

Andrés López Hernández, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Vall d´Hebrón

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEL-TAMO/R-GemOx-08-04/v2

NCT ID:

NCT01562977

Start Date:

April 2011

Completion Date:

April 2017

Related Keywords:

  • Aggressive Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Mantle Cell Lymphoma
  • Aggression
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell

Name

Location