Know Cancer

or
forgot password

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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Lymphoma, Non-Hodgkin

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to treatment failure

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Agnieszka Korfel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charite University, Berlin, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

NHL-ZNS-Rezidiv

NCT ID:

NCT01148173

Start Date:

October 2007

Completion Date:

October 2012

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • CNS relapse
  • aggressive lymphoma
  • HD-ASCT
  • Aggression
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location