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High-dose Chemotherapy and Stem Cell Transplantation for Central Nervous System (CNS) Relapse of Aggressive Lymphomas

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Combined systemic and intrathecal chemotherapy followed by HD-ASCT
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring CNS relapse, aggressive lymphoma, HD-ASCT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • highly-malignant non-Hodgkins-Lymphoma, mantle-cell lymphoma or follicular lymphoma 3°
  • CNS relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations
  • ECOG performance score ≤2
  • no active infection
  • negative HIV-serology
  • adequate renal function (creatinine clearance > 50 ml/min)
  • adequate bone marrow function (granulocytes >1500/μl, platelets > 80000/μl)
  • normal bilirubin, AST < 3 x UNL
  • negative pregnancy test

Exclusion Criteria:

  • newly diagnosed NHL with primary CNS involvement
  • indolent NHL, lymphoblastic NHL or Burkitt lymphoma
  • preceding CNS irradiation
  • pretreatment of CNS relapse other than corticosteroids
  • immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation
  • second cancer other than basalioma or cervical carcinoma in situ within the last 5 years
  • unfit to receive an intensive chemotherapy
  • pregnancy or breastfeeding
  • known intolerance to MTX, ifosfamide, Depocyte, cytarabine, thiotepa, carmustine or etoposide

Sites / Locations

  • Charité UniversitätsmedizinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Systemic and intrathecal chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Time to treatment failure

Secondary Outcome Measures

Overall survival
Remission rate
Toxicity

Full Information

First Posted
June 21, 2010
Last Updated
June 21, 2010
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01148173
Brief Title
High-dose Chemotherapy and Stem Cell Transplantation for Central Nervous System (CNS) Relapse of Aggressive Lymphomas
Official Title
Combined Systemic and Intrathecal Chemotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation for CNS Relapse of Aggressive Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose chemotherapy and autologous stem cell transplantation as a potentially curative approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
CNS relapse, aggressive lymphoma, HD-ASCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Systemic and intrathecal chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Combined systemic and intrathecal chemotherapy followed by HD-ASCT
Other Intervention Name(s)
MTX, Holoxan, Depocyt, Tepadina, BCNU
Intervention Description
Methotrexate Ifosfamide Cytarabine Thiotepa Liposomal cytarabine (intrathecal) Carmustine Etoposide Autologous stem cell transplantation
Primary Outcome Measure Information:
Title
Time to treatment failure
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
Title
Remission rate
Time Frame
3 months
Title
Toxicity
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: highly-malignant non-Hodgkins-Lymphoma, mantle-cell lymphoma or follicular lymphoma 3° CNS relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations ECOG performance score ≤2 no active infection negative HIV-serology adequate renal function (creatinine clearance > 50 ml/min) adequate bone marrow function (granulocytes >1500/μl, platelets > 80000/μl) normal bilirubin, AST < 3 x UNL negative pregnancy test Exclusion Criteria: newly diagnosed NHL with primary CNS involvement indolent NHL, lymphoblastic NHL or Burkitt lymphoma preceding CNS irradiation pretreatment of CNS relapse other than corticosteroids immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation second cancer other than basalioma or cervical carcinoma in situ within the last 5 years unfit to receive an intensive chemotherapy pregnancy or breastfeeding known intolerance to MTX, ifosfamide, Depocyte, cytarabine, thiotepa, carmustine or etoposide
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Fischer, MD
Phone
+ 49 30 8445
Ext
4096
Email
lars.fischer@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Agnieszka Korfel, MD
Phone
+ 49 30 8445
Ext
4096
Email
agnieszka.korfel@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnieszka Korfel, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Fischer, MD
Phone
+49308445
Ext
4096
Email
lars.fischer@charite.de
First Name & Middle Initial & Last Name & Degree
Agnieszka Korfel, MD
Phone
+49308445
Ext
4096
Email
agnieszka.korfel@charite.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
23242601
Citation
Korfel A, Elter T, Thiel E, Hanel M, Mohle R, Schroers R, Reiser M, Dreyling M, Eucker J, Scholz C, Metzner B, Roth A, Birkmann J, Schlegel U, Martus P, Illerhaus G, Fischer L. Phase II study of central nervous system (CNS)-directed chemotherapy including high-dose chemotherapy with autologous stem cell transplantation for CNS relapse of aggressive lymphomas. Haematologica. 2013 Mar;98(3):364-70. doi: 10.3324/haematol.2012.077917. Epub 2012 Dec 14.
Results Reference
derived

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High-dose Chemotherapy and Stem Cell Transplantation for Central Nervous System (CNS) Relapse of Aggressive Lymphomas

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