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Phase II Study Evaluating the Combination Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy Containing High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.


Phase 2
18 Years
N/A
Not Enrolling
Both
Cerebral Lymphoma B Cell Refractory

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Trial Information

Phase II Study Evaluating the Combination Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy Containing High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.


Inclusion Criteria:



- Patient with cerebral lymphoma B cell refractory or relapsed within 12 months after
first-line chemotherapy with high-dose methotrexate (1.5 g / m²) and high dose
cytarabine (2g / m²) and / or radiotherapy or autologous, or patient with an
indication against these treatments.

Refractory disease is defined by the absence of objective response to treatment or relapse
within 3 months of it. A relapse is defined as disease progression after obtaining a
complete or partial response.

- Age greater than or equal to 18 years

- Performance Index less than 4

- Illness measured by CT or MRI

- Hematologic adequate: neutrophils> 1.5 x 106 / L, platelets> 100x106 / L

- Adequate hepatic function: ALT / AST and bilirubin less than the upper limit of the
normal laboratory

- Adequate renal function: creatinine clearance greater than 60 ml / min

- adequate cardiac function measured by ejection fraction of the left ventricle> 50% by
echocardiography

- Informed consent signed

- Negative pregnancy test for women of childbearing age

- Able to understand the arrangements for monitoring the study and to comply

- Corticosteroids are only accepted during the first cycle

Exclusion Criteria:

- Patients with immunosuppression from any cause (HIV, history of transplantation,
immunosuppressive treatments ...)

- Prior treatment MYOCET ® or other anthracycline

- Active infection

- Surgery large (more than 3 days hospitalization) within 28 days before enrollment in
the study, except for a diagnostic neurosurgical

- Hypersensitivity to any component of the treatment

- Contraindications to the administration of MYOCET ® and / or dexamethasone
Participation in a clinical trial within 4 weeks prior to study entry

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Answer at treatment

Outcome Description:

Answer, whether complete or partial, according to the International Primary CNS Lymphoma Collaborative Group (IPCG) (ASH 2004) after two cycles of treatment (4 infusions MYOCET ®).

Outcome Time Frame:

after 2 cycles of treatment (84 days)

Safety Issue:

Yes

Principal Investigator

Adrian TEMPESCUL, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

University hospital of Brest

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

RB 12.032 - MYLY

NCT ID:

NCT01848652

Start Date:

May 2013

Completion Date:

January 2017

Related Keywords:

  • Cerebral Lymphoma B Cell Refractory
  • cerebral lymphoma B cell refractory
  • Myocet
  • efficacy
  • safety
  • Lymphoma
  • Lymphoma, B-Cell

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