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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Unknown status

CT.gov ID

NCT01148173

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin	Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2007

Anticipated Primary Completion Date :

Oct 1, 2011

Anticipated Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systemic and intrathecal chemotherapy	Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT Methotrexate Ifosfamide Cytarabine Thiotepa Liposomal cytarabine (intrathecal) Carmustine Etoposide Autologous stem cell transplantation Other Names: MTX Holoxan Depocyt Tepadina BCNU

Arm

Intervention/Treatment

Experimental: Systemic and intrathecal chemotherapy

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

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

Other Names:

MTX

Holoxan

Depocyt

Tepadina

BCNU

Outcome Measures

Primary Outcome Measures

Time to treatment failure [2 years]

Secondary Outcome Measures

Overall survival [2 years]
Remission rate [3 months]
Toxicity [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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