Freiburg ZNS-NHL Study

Sponsor

University Hospital Freiburg (Other)

Overall Status

Unknown status

CT.gov ID

NCT00647049

Collaborator

University Hospital Tuebingen (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL].

Condition or Disease	Intervention/Treatment	Phase
Primary Non Hodgkin Lymphoma of the Central Nervous System	Drug: methotrexate Drug: Rituximab Drug: Cytarabine Drug: Thiotepa Drug: Carmustin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Freiburg ZNS-NHL Study: Therapy for Patients With Primary Non-Hodgkin Lymphoma of the CNS - Sequential High Dosage Chemotherapy With Autologous Peripheral Blood Stem Cell Plantation

Study Start Date :

Jan 1, 2007

Anticipated Primary Completion Date :

May 1, 2013

Anticipated Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A first diagnosis of PCNSL: combined chemotherapy with methotrexate	Drug: methotrexate 8000mg/m2 i.v., max. 2 cycles Other Names: MTX Drug: Rituximab 375mg/m2, max. 8 times Drug: Cytarabine 3000mg/m2 die i.v., 2 days (max. 2 cycles) Other Names: Arabinoside Drug: Thiotepa 40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days Drug: Carmustin 400mg/m2 i.v. for 1 day Other Names: BCNU Bis-Chlorethyl-Nitrosourea
Experimental: B Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy	Drug: Rituximab 375mg/m2, max. 8 times Drug: Cytarabine 3000mg/m2 die i.v., 2 days (max. 2 cycles) Other Names: Arabinoside Drug: Thiotepa 40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days Drug: Carmustin 400mg/m2 i.v. for 1 day Other Names: BCNU Bis-Chlorethyl-Nitrosourea

Arm

Intervention/Treatment

Experimental: A

first diagnosis of PCNSL: combined chemotherapy with methotrexate

Drug: methotrexate

8000mg/m2 i.v., max. 2 cycles

Other Names:

MTX

Drug: Rituximab

375mg/m2, max. 8 times

Drug: Cytarabine

3000mg/m2 die i.v., 2 days (max. 2 cycles)

Other Names:

Arabinoside

Drug: Thiotepa

40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days

Drug: Carmustin

400mg/m2 i.v. for 1 day

Other Names:

BCNU

Bis-Chlorethyl-Nitrosourea

Experimental: B

Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy

Drug: Rituximab

375mg/m2, max. 8 times

Drug: Cytarabine

3000mg/m2 die i.v., 2 days (max. 2 cycles)

Other Names:

Arabinoside

Drug: Thiotepa

40mg/m2 i.v. (max. 2 cycles) 2 x 5mg/kg/die i.v. for 2 days

Drug: Carmustin

400mg/m2 i.v. for 1 day

Other Names:

BCNU

Bis-Chlorethyl-Nitrosourea

Outcome Measures

Primary Outcome Measures

Complete response rate [30 days after blood stem cell transplantation]

Secondary Outcome Measures

Duration of response [within 5 years]
Overall survival time [within 5 years]
Neuropsychological state according to Mini-Mental State [within 5 years]
Neuropsychological assessment (digit span, Hopkins verbal Learning Test-Revised, Trials 1-3, Brief Test of Attention, Trial Making Test, Grooved Pegboard, 6. HVLT-R , EORTC L C30 , EORTC BN20) [within 5 years]
(Serious) adverse events ([S]AEs) [within 30 days after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

group A: first diagnosis of PCNSL, histologically confirmed
group B: relapse or progression of PCNSL after MTX containing chemotherapy
age 18 - 65 years
not legally incompetent, physically or mentally incapable of giving consent
written signed and dated informed consent of the legal representative and - if possible - of the patient

Exclusion Criteria:

manifestations of further lymphoma outside the CNS
sero-positive for HIV
severe pulmonary, cardiac, hepatic, renal impairment
neutrophil count < 2.000/µl, platelet count < 100.000/µl
pulmonary disease with IVC < 55%, DLCO < 40%
cardiac ejection fraction < 50%, uncontrolled malign arrhythmia
creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
bilirubin > 2mg/dl
ascites or pleural effusion (> 500ml)
pregnancy o r lactation
women with childbearing potential without sufficient contraception
participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
known or current drug or alcohol abuse
known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorin, dexamethasone, neupogen and neulasta.