Early CNS prophylaxis in younger patients with high risk diffuse large B-cell lymphoma.

Dose densified chemoimmunotherapy with early CNS prophylaxis in patients less than 65 years with high risk (aaIPI=2) Diffuse Large B-Cell Lymphoma. - CHIC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023125-38-FI

Enrollment

130

Registered

2010-11-24

Start date

2011-01-05

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse large B-cell lymphoma (DLBCL) MedDRA version: 14.1 Level: PT Classification code 10012825 Term: Diffuse large B-cell lymphoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10012824 Term: Diffuse large B-cell lymphoma stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code

Interventions

Trade Name: DepoCyte Pharmaceutical Form: Injection INN or Proposed INN: CYTARABINE CAS Number: 147-94-4 Current Sponsor code: not applicable Other descriptive name: not applicable Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 - =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 CSF cytology. Positive CSF flow cytometry below diagnostic threshold level by cytology is allowed Pleural or peritoneal fluid that cannot be drained safely Conditions that may be compatible with impaired cerebrospinal fluid flow Hypersensitity to the active substance or any of the other ingredients Patients participating in other clinical studies, unless followed for survival

Design outcomes

Primary

Measure	Time frame
Main Objective: Time to treatment failure from date of registration. CNS relapse rate at 1,5 years.;Secondary Objective: Toxicity Clinical response rate Incidence of CNS relapse in CSF cytology neg/flow cytometry positive cases Incidence of CNS relapse in a subgroup of patients with more than one extranodal site and elevated LDH Progression free survival (3 years) Overall survival (3 years) Molecular predictors ;Primary end point(s): 1. Time to treatment failure Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. Otherwise, patients will be censored at the last date they were known to be alive. For patients not responding at any time point on study treatment, TTF is defined as 1 day. ;Timepoint(s) of evaluation of this end point: After three cycles, after last cycle and four times per year for the first two years of follow-up. After that twice per year fot another three years of follow-up.	—

Measure

Time frame

Main Objective: Time to treatment failure from date of registration. CNS relapse rate at 1,5 years.;Secondary Objective: Toxicity Clinical response rate Incidence of CNS relapse in CSF cytology neg/flow cytometry positive cases Incidence of CNS relapse in a subgroup of patients with more than one extranodal site and elevated LDH Progression free survival (3 years) Overall survival (3 years) Molecular predictors ;Primary end point(s): 1. Time to treatment failure Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. Otherwise, patients will be censored at the last date they were known to be alive. For patients not responding at any time point on study treatment, TTF is defined as 1 day. ;Timepoint(s) of evaluation of this end point: After three cycles, after last cycle and four times per year for the first two years of follow-up. After that twice per year fot another three years of follow-up.

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Secondary

Measure	Time frame
Secondary end point(s): 2. Overall survival (all causes of death) The time from the registration date to the date of death. Patients still alive or lost to follow-up are censored at the last date they were known to be alive. 3. Disease free survival The time from the first assessment within 2 months of completion of therapy that documents response to the date of disease progression. Otherwise, the patients are censored at the last date of follow up. Patients still alive in a CR or lost to follow-up are censored at the last date they were known to be alive. Patients who die due to causes other than NHL are censored at the date of death. 4. Cause of death During the study and after its completion the cause of death will be registered according to the following cause-of-death criteria: a. Lymphoma b. Treatment toxicity c. Secondary malignancy d. Other disease not related to 1, 2 or 3 e. Other cause;Timepoint(s) of evaluation of this end point: After three cycles, after last cycle and four times per year for the first two years of follow-up. After that twice per year fot another three years of follow-up.	—

Measure

Time frame

Secondary end point(s): 2. Overall survival (all causes of death) The time from the registration date to the date of death. Patients still alive or lost to follow-up are censored at the last date they were known to be alive. 3. Disease free survival The time from the first assessment within 2 months of completion of therapy that documents response to the date of disease progression. Otherwise, the patients are censored at the last date of follow up. Patients still alive in a CR or lost to follow-up are censored at the last date they were known to be alive. Patients who die due to causes other than NHL are censored at the date of death. 4. Cause of death During the study and after its completion the cause of death will be registered according to the following cause-of-death criteria: a. Lymphoma b. Treatment toxicity c. Secondary malignancy d. Other disease not related to 1, 2 or 3 e. Other cause;Timepoint(s) of evaluation of this end point: After three cycles, after last cycle and four times per year for the first two years of follow-up. After that twice per year fot another three years of follow-up.

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Countries

Denmark, Finland, Norway, Sweden

Contacts

Public ContactSirpa Leppä

Nordic Lymphoma Group

sirpa.leppa@helsinki.fi+3589471 73197

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026