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

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ClinicalTrials.gov Identifier: NCT01848652
Recruitment Status : Terminated (The laboratory's partner on this study decides to terminate the contract with the CHRU Brest, because of the difficulty of the recruitment.)
First Posted : May 7, 2013
Last Update Posted : July 14, 2015
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding strict eye lymphomas.

This is a Phase II, open, prospective, multicenter, non-comparative with direct individual benefit.


Condition or disease Intervention/treatment Phase
Cerebral Lymphoma B Cell Refractory Drug: infusion of MYOCET Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: MYOCET Drug: infusion of MYOCET



Primary Outcome Measures :
  1. Answer at treatment [ Time Frame: after 2 cycles of treatment (84 days) ]
    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 ®).


Secondary Outcome Measures :
  1. Tolerance at treatment [ Time Frame: after each cycle and until the end of follow ]
    Tolerance, assessed according to the criteria of the National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) version (version 4.03) after administration of each cycle, overall survival, progression-free and disease-free event for complete responses.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848652


Locations
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France
CHRU de Brest
Brest, France, 29609
Hôpital Pitié Salpêtrière
Paris, France, 75651
CHU de Rennes Hôpital Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
University Hospital, Brest
Teva Pharmaceuticals USA
Investigators
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Principal Investigator: Adrian TEMPESCUL, Dr University hospital of Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01848652     History of Changes
Other Study ID Numbers: RB 12.032 - MYLY
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015

Keywords provided by University Hospital, Brest:
cerebral lymphoma B cell refractory
Myocet
efficacy
safety

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cytarabine
Dexamethasone
Doxorubicin
Liposomal doxorubicin
Methotrexate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors