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Primary DiseasePhase 2CHICNCT01325194

CHemoImmunotherapy With Early Central Nervous System (CNS) Prophylaxis

A Phase 2 study testing liposomal cytarabine in people with Primary Disease, run by Nordic Lymphoma Group at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Primary Disease
What is being tested?
liposomal cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
4 sitesin 4 countries
Study dates
Mar 2011to 31 Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Denmark1 site

  • Department of Hematology, Århus University Hospital

    Aarhus

Other trials in Denmark

Finland1 site

  • Department of Oncology, Helsinki University Central Hospital

    Helsinki

Other trials in Finland

Norway1 site

  • Department of Oncology, Oslo University Hospital

    Oslo

Other trials in Norway

Sweden1 site

  • Department of Oncology, Lund University Hospital

    Lund

Other trials in Sweden

About this study

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

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.

Conditions
Primary Disease
Being tested
liposomal cytarabine
Keywords
DLBCL, FL grade 3B, high risk, CNS prophylaxis, chemoimmunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • liposomal cytarabineDrug

    Also called Depocyte

    50 mg intrathecally three times

Study groups in NCT01325194
Study groupRoleWhat they receive
CNS prophylaxisExperimentalNot described
Receives: Drug: liposomal cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to treatment failure

    Measured: 3 and 5 years

Secondary outcomes (8)

  1. Maximal hematological, gastrointestinal, neuronal and other toxicities

    Measured: Treatment period (5 years)

  2. Clinical response rate

    Measured: Treatment period (5 years)

  3. Incidence of central nervous system(CNS) relapse in cerebrospinal fluid (CSF )cytology neg/flow cytometry positive cases

    Measured: 3 and 5 years

  4. Incidence of CNS relapse in a subgroup of patients with more than one extranodal site and elevated lactate dehydrogenase (LDH)

    Measured: 3 and 5 years

  5. Progression free survival

    Measured: 3 and 5 years

  6. Overall survival

    Measured: 3 and 5 years

  7. Molecular predictors

    Measured: 3 years

  8. CNS relapse rate

    Measured: 1,5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionNov 2018
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01325194
Sponsor's protocol ID
NLG-LBC-05
Acronym
CHIC
Status last verified
Mar 2020
First submitted
14 Mar 2011
Last updated
3 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • Mayerhoefer ME, Kienzle A, Woo S, Vargas HA. Update on Liquid Biopsy. Radiology. 2025 Jun;315(3):e241030. doi: 10.1148/radiol.241030.

    PubMed 40525978

  • Arffman M, Meriranta L, Autio M, Holte H, Jorgensen J, Brown P, Jyrkkio S, Jerkeman M, Drott K, Fluge O, Bjorkholm M, Karjalainen-Lindsberg ML, Beiske K, Pedersen MO, Leivonen SK, Leppa S. Inflammatory and subtype-dependent serum protein signatures predict survival beyond the ctDNA in aggressive B cell lymphomas. Med. 2024 Jun 14;5(6):583-602.e5. doi: 10.1016/j.medj.2024.03.007. Epub 2024 Apr 4.

    PubMed 38579729

  • Vajavaara H, Leivonen SK, Jorgensen J, Holte H, Leppa S. Low lymphocyte-to-monocyte ratio predicts poor outcome in high-risk aggressive large B-cell lymphoma. EJHaem. 2022 Jun 23;3(3):681-687. doi: 10.1002/jha2.409. eCollection 2022 Aug.

    PubMed 36051040

  • Leppa S, Jorgensen J, Tierens A, Meriranta L, Ostlie I, de Nully Brown P, Fagerli UM, Larsen TS, Mannisto S, Munksgaard L, Maisenholder M, Vasala K, Meyer P, Jerkeman M, Bjorkholm M, Fluge O, Jyrkkio S, Liestol K, Ralfkiaer E, Spetalen S, Beiske K, Karjalainen-Lindsberg ML, Holte H. Patients with high-risk DLBCL benefit from dose-dense immunochemotherapy combined with early systemic CNS prophylaxis. Blood Adv. 2020 May 12;4(9):1906-1915. doi: 10.1182/bloodadvances.2020001518.

    PubMed 32380536

  • Autio M, Leivonen SK, Bruck O, Mustjoki S, Meszaros Jorgensen J, Karjalainen-Lindsberg ML, Beiske K, Holte H, Pellinen T, Leppa S. Immune cell constitution in the tumor microenvironment predicts the outcome in diffuse large B-cell lymphoma. Haematologica. 2021 Mar 1;106(3):718-729. doi: 10.3324/haematol.2019.243626.

    PubMed 32079690

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing liposomal cytarabine in people with Primary Disease, run by Nordic Lymphoma Group at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark, Finland, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to treatment failure (time frame: 3 and 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01325194, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.

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