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

March 2, 2020 updated by: Nordic Lymphoma Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Århus, Denmark
        • Department of Hematology, Århus University Hospital
  • Finland
      • Helsinki, Finland
        • Department of Oncology, Helsinki University Central Hospital
  • Norway
      • Oslo, Norway
        • Department of Oncology, Oslo University Hospital
  • Sweden
      • Lund, Sweden
        • Department of Oncology, Lund University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CNS prophylaxis
Drug: liposomal cytarabine
50 mg intrathecally three times
Other Names:
  • Depocyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to treatment failure
Time Frame: 3 and 5 years
3 and 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 3 and 5 years
3 and 5 years
Overall survival
Time Frame: 3 and 5 years
3 and 5 years
Maximal hematological, gastrointestinal, neuronal and other toxicities
Time Frame: Treatment period (5 years)
Treatment period (5 years)
Clinical response rate
Time Frame: Treatment period (5 years)
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
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
3 and 5 years
Molecular predictors
Time Frame: 3 years
3 years
CNS relapse rate
Time Frame: 1,5 years
1,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Lymphoma Group

Collaborators

Mundipharma Pte Ltd.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NLG-LBC-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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