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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01148173

Enrollment

Registered

2010-06-22

Start date

2007-10-31

Completion date

2012-10-31

Last updated

2010-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Non-Hodgkin

Keywords

CNS relapse, aggressive lymphoma, HD-ASCT

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.

Interventions

DRUGCombined systemic and intrathecal chemotherapy followed by HD-ASCT

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Time to treatment failure	2 years

Secondary

Measure	Time frame
Overall survival	2 years
Remission rate	3 months
Toxicity	1 year

Countries

Germany

Contacts

Primary ContactLars Fischer, MD

lars.fischer@charite.de+ 49 30 8445

Backup ContactAgnieszka Korfel, MD

agnieszka.korfel@charite.de+ 49 30 8445

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026