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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)

Primary Purpose

Cerebral Lymphoma B Cell Refractory

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
infusion of MYOCET
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Lymphoma B Cell Refractory focused on measuring cerebral lymphoma B cell refractory, Myocet, efficacy, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de Brest
  • Hôpital Pitié Salpêtrière
  • CHU de Rennes Hôpital Pontchaillou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MYOCET

Arm Description

Outcomes

Primary Outcome Measures

Answer at treatment
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

Tolerance at treatment
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.

Full Information

First Posted
May 3, 2013
Last Updated
July 13, 2015
Sponsor
University Hospital, Brest
Collaborators
Teva Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT01848652
Brief Title
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.
Acronym
MYLY
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
The laboratory's partner on this study decides to terminate the contract with the CHRU Brest, because of the difficulty of the recruitment.
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Teva Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Lymphoma B Cell Refractory
Keywords
cerebral lymphoma B cell refractory, Myocet, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MYOCET
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
infusion of MYOCET
Primary Outcome Measure Information:
Title
Answer at treatment
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 ®).
Time Frame
after 2 cycles of treatment (84 days)
Secondary Outcome Measure Information:
Title
Tolerance at treatment
Description
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.
Time Frame
after each cycle and until the end of follow

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian TEMPESCUL, Dr
Organizational Affiliation
University hospital of Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hôpital Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU de Rennes Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Learn more about this trial

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.

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