CHemoImmunotherapy With Early Central Nervous System (CNS) Prophylaxis (CHIC)

Nordic Lymphoma Group

Status and phase

Completed

Phase 2

Conditions

Primary Disease

Treatments

Drug: liposomal cytarabine

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT01325194

NLG-LBC-05

Details and patient eligibility

About

The purpose is to test whether early central nervous system (CNS) prophylaxis given at the beginning of therapy for young high risk diffuse large B-cell lymphoma (DLBCL) patients is feasible and could reduce the risk of CNS relapses. Early CNS prophylaxis with two courses high dose methotrexate (HD-MTX) in combination with rituximab-cyclophosphamide-doxorubicin-vincristine-prednison (R-CHOP) is followed by four courses of R-CHOP14 and etoposide (E) and one course of HD-Ara-C. In addition the patients will receive three courses of liposomal cytarabine intrathecally. The results will be compared to a recent Nordic CRY-04 study. Shifting of CNS prophylaxis to the beginning of the therapy offers a potential to overcome the subclinical disease and thus reduce the risk of early clinical CNS recurrence. As flow cytometry (FCM) can improve the sensitivity for detecting occult leptomeningeal disease over cytology , FCM from cerebrospinal fluid will be incorporated into the staging procedures.

Enrollment

143 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 - < 65 years. Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) based on WHO 2008 Lymphoma Classification
Follicular lymphomas (FLs) grade 3b is allowed

Patients in at least stage II with age adjusted international prognostic score (IPI score) of 2 or 3:

Stage III /IV and elevated LDH
Stage III/IV and WHO performance status 2 - 3
Stage II and elevated LDH and WHO performance status 2 - 3 And/or patients with
More than one extranodal site
Testicular lymphoma, stage IIE and higher
Paranasal sinus and orbital lymphoma with destruction of bone
Large cell infiltration of the bone marrow

Exclusion criteria

Severe cardiac disease: cardiac function grade 3-4
Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule
Pregnancy/lactation
Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment
Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons
Known HIV positivity
Uncontrolled infectious disease, including meningeal infection
Active cancer except basal cell carcinoma and cervical carcinoma in situ during the last five years
Earlier treatment containing anthracyclins
Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol
CNS disease as diagnosed by MRI or cerebrospinal fluid (CSF) cytology. Positive CSF flow cytometry below diagnostic threshold level by cytology is allowed
Pleural or peritoneal fluid that cannot be drained safely
Hypersensitivity to the active substance or any of the other ingredients
Patients participating in other clinical studies, unless followed for survival