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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01148173
• Other study ID #: NHL-ZNS-Rezidiv
• Status: Recruiting
• Phase: Phase 2
• First received: June 21, 2010
• Last updated: June 21, 2010
• Start date: October 2007
• Est. completion date: October 2012

Study information

• Verified date: November 2007
• Source: Charite University, Berlin, Germany
• Contact: Lars Fischer, MD
• Phone: + 49 30 8445
• Email: lars.fischer[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Combined systemic and intrathecal chemotherapy followed by HD-ASCT
Methotrexate Ifosfamide Cytarabine Thiotepa Liposomal cytarabine (intrathecal) Carmustine Etoposide Autologous stem cell transplantation

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment failure		2 years	No
Secondary	Overall survival		2 years	No
Secondary	Remission rate		3 months	No
Secondary	Toxicity		1 year	Yes