NCT01148173

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

June 22, 2010

Status Verified

November 1, 2007

Enrollment Period

4 years

First QC Date

June 21, 2010

Last Update Submit

June 21, 2010

Conditions

Lymphoma, Non-Hodgkin

Keywords

CNS relapseaggressive lymphomaHD-ASCT

Outcome Measures

Primary Outcomes (1)

  • Time to treatment failure

    2 years

Secondary Outcomes (3)

  • Overall survival

    2 years

  • Remission rate

    3 months

  • Toxicity

    1 year

Study Arms (1)

Systemic and intrathecal chemotherapy

EXPERIMENTAL
Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT

Interventions

Combined systemic and intrathecal chemotherapy followed by HD-ASCTDRUG

Methotrexate Ifosfamide Cytarabine Thiotepa Liposomal cytarabine (intrathecal) Carmustine Etoposide Autologous stem cell transplantation

Also known as: MTX, Holoxan, Depocyt, Tepadina, BCNU
Systemic and intrathecal chemotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin

Berlin, State of Berlin, 12200, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23242601DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

IfosfamideThiotepaCarmustine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTriethylenephosphoramideAziridinesAzirinesNitrosourea CompoundsUreaAmidesNitroso Compounds

Study Officials

  • Agnieszka Korfel, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Fischer, MD

CONTACT

+ 49 30 8445lars.fischer@charite.de

Agnieszka Korfel, MD

CONTACT

+ 49 30 8445agnieszka.korfel@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 22, 2010

Study Start

October 1, 2007

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

June 22, 2010

Record last verified: 2007-11

Locations

DE(1)