Phase II Study Evaluating a Combination of Pegylated Lipo... | NCT01848652

Studies
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.

NCT01848652

Sponsor

University Hospital, Brest

Status

Terminated

Last Update Posted

Jul 14, 2015Estimated

Enrollment

5Actual

Phase

Phase 2

Conditions

Cerebral Lymphoma B Cell Refractory

Interventions

infusion of MYOCET

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

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.

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

May 3, 2013

First Submission Date that Met QC Criteria

May 3, 2013

First Posted Date

May 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2015

Last Update Posted Date

Jul 14, 2015Estimated

Name	Class
Teva Pharmaceuticals USA	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Label	Type	Description	Intervention Names
MYOCET	Experimental		Drug: infusion of MYOCET

Name	Type	Description	Arm Group Labels	Other Names
infusion of MYOCET	Drug		MYOCET

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 ®).	after 2 cycles of treatment (84 days)

Secondary Outcomes

Measure	Description	Time Frame
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.	after each cycle and until the end of follow

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France
Hôpital Pitié Salpêtrière