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

June 21, 2010 updated by: Charite University, Berlin, Germany

Combined Systemic and Intrathecal Chemotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation for CNS Relapse of Aggressive Lymphomas

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Systemic and intrathecal chemotherapy
Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT
Methotrexate Ifosfamide Cytarabine Thiotepa Liposomal cytarabine (intrathecal) Carmustine Etoposide Autologous stem cell transplantation
Other Names:
  • Holoxan
  • Tepadina
  • BCNU
  • MTX
  • Depocyt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to treatment failure
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years
Toxicity
Time Frame: 1 year
1 year
Remission rate
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Agnieszka Korfel, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 21, 2010

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHL-ZNS-Rezidiv

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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