CHemoImmunotherapy With Early Central Nervous System (CNS) Prophylaxis (CHIC)
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ClinicalTrials.gov Identifier: NCT01325194 |
Recruitment Status :
Completed
First Posted : March 29, 2011
Last Update Posted : March 3, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Disease | Drug: liposomal cytarabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 143 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Dose Densified Chemoimmunotherapy With Early CNS Prophylaxis in Patients Less Than 65 Years With High Risk (aaIPI≥ 2) Diffuse Large B-Cell Lymphoma |
Actual Study Start Date : | March 2011 |
Actual Primary Completion Date : | November 2018 |
Actual Study Completion Date : | December 31, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: CNS prophylaxis |
Drug: liposomal cytarabine
50 mg intrathecally three times
Other Name: Depocyte |
- Time to treatment failure [ Time Frame: 3 and 5 years ]
- Maximal hematological, gastrointestinal, neuronal and other toxicities [ Time Frame: Treatment period (5 years) ]
- Clinical response rate [ Time Frame: Treatment period (5 years) ]
- Incidence of central nervous system(CNS) relapse in cerebrospinal fluid (CSF )cytology neg/flow cytometry positive cases [ Time Frame: 3 and 5 years ]
- Incidence of CNS relapse in a subgroup of patients with more than one extranodal site and elevated lactate dehydrogenase (LDH) [ Time Frame: 3 and 5 years ]
- Progression free survival [ Time Frame: 3 and 5 years ]
- Overall survival [ Time Frame: 3 and 5 years ]
- Molecular predictors [ Time Frame: 3 years ]
- CNS relapse rate [ Time Frame: 1,5 years ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325194
Denmark | |
Department of Hematology, Århus University Hospital | |
Århus, Denmark | |
Finland | |
Department of Oncology, Helsinki University Central Hospital | |
Helsinki, Finland | |
Norway | |
Department of Oncology, Oslo University Hospital | |
Oslo, Norway | |
Sweden | |
Department of Oncology, Lund University Hospital | |
Lund, Sweden |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Nordic Lymphoma Group |
ClinicalTrials.gov Identifier: | NCT01325194 |
Other Study ID Numbers: |
NLG-LBC-05 |
First Posted: | March 29, 2011 Key Record Dates |
Last Update Posted: | March 3, 2020 |
Last Verified: | March 2020 |
DLBCL FL grade 3B high risk CNS prophylaxis chemoimmunotherapy |
Cytarabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |