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Dose Densified Chemoimmunotherapy With Early CNS Prophylaxis in Patients Less Than 65 Years With High Risk (aaIPI≥ 2) Diffuse Large B-Cell Lymphoma


Phase 2
18 Years
64 Years
Open (Enrolling)
Both
Primary Disease

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Trial Information

Dose Densified Chemoimmunotherapy With Early CNS Prophylaxis in Patients Less Than 65 Years With High Risk (aaIPI≥ 2) Diffuse Large B-Cell Lymphoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to treatment failure

Outcome Time Frame:

3 and 5 years

Safety Issue:

No

Authority:

Finland: Ethics Committee

Study ID:

NLG-LBC-05

NCT ID:

NCT01325194

Start Date:

March 2011

Completion Date:

March 2017

Related Keywords:

  • Primary Disease
  • DLBCL
  • FL grade 3B
  • high risk
  • CNS prophylaxis
  • chemoimmunotherapy
  • Lymphoma, Large B-Cell, Diffuse

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