Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 3, 2013
First Posted Date  ICMJE May 7, 2013
Last Update Posted Date July 14, 2015
Study Start Date  ICMJE October 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
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 ®).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01848652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Lymphoma B Cell Refractory
Intervention  ICMJE Drug: infusion of MYOCET
Study Arms  ICMJE Experimental: MYOCET
Intervention: Drug: infusion of MYOCET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 27, 2015)
5
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2013)
25
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848652
Other Study ID Numbers  ICMJE RB 12.032 - MYLY
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Teva Pharmaceuticals USA
Investigators  ICMJE
Principal Investigator: Adrian TEMPESCUL, Dr University hospital of Brest
PRS Account University Hospital, Brest
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP