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

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ClinicalTrials.gov Identifier: NCT01325194
Recruitment Status : Active, not recruiting
First Posted : March 29, 2011
Last Update Posted : September 7, 2017
Sponsor:
Collaborators:
Mundipharma Pte Ltd.
Amgen
Information provided by (Responsible Party):
Nordic Lymphoma Group

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Primary Disease Drug: liposomal cytarabine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
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 : December 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Cytarabine

Arms and Interventions
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Arm Intervention/treatment
Experimental: CNS prophylaxis Drug: liposomal cytarabine
50 mg intrathecally three times
Other Name: Depocyte


Outcome Measures
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Primary Outcome Measures :
  1. Time to treatment failure [ Time Frame: 3 and 5 years ]

Secondary Outcome Measures :
  1. Maximal hematological, gastrointestinal, neuronal and other toxicities [ Time Frame: Treatment period (5 years) ]
  2. Clinical response rate [ Time Frame: Treatment period (5 years) ]
  3. Incidence of central nervous system(CNS) relapse in cerebrospinal fluid (CSF )cytology neg/flow cytometry positive cases [ Time Frame: 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) [ Time Frame: 3 and 5 years ]
  5. Progression free survival [ Time Frame: 3 and 5 years ]
  6. Overall survival [ Time Frame: 3 and 5 years ]
  7. Molecular predictors [ Time Frame: 3 years ]
  8. CNS relapse rate [ Time Frame: 1,5 years ]

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

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
Contacts and Locations
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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


Locations
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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
Sponsors and Collaborators
Nordic Lymphoma Group
Mundipharma Pte Ltd.
Amgen
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: Nordic Lymphoma Group
ClinicalTrials.gov Identifier: NCT01325194     History of Changes
Other Study ID Numbers: NLG-LBC-05
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017

Keywords provided by Nordic Lymphoma Group:
DLBCL
FL grade 3B
high risk
CNS prophylaxis
chemoimmunotherapy

Additional relevant MeSH terms:
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Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
 Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs