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

Phase 2

• Conditions: Lymphoma, Non-Hodgkin
• Interventions: Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT

• Registration Number: NCT01148173
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Status Verified: 2007-11
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Last Update Submitted: 2010-06-21
• Study First Posted: 2010-06-22
• Last Update Posted: 2010-06-22
• Primary Completion: 2011-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Systemic and intrathecal chemotherapy	Combined systemic and intrathecal chemotherapy followed by HD-ASCT	-

Primary Outcome Measures

Name	Time	Method
Time to treatment failure	2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years
Remission rate	3 months
Toxicity	1 year

Trial Locations

Locations (1)

Charité Universitätsmedizin; 🇩🇪 Berlin, Germany