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Trial of Idelalisib in Patients With Relapsed Diffuse Large B-cell Lymphoma (ILIAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03576443
Recruitment Status : Active, not recruiting
First Posted : July 3, 2018
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Nordic Lymphoma Group

Brief Summary:
Based on the high response rate in heavily pretreated patients with indolent B-cell lymphomas, among which it is likely that many have undetected transformed disease, the investigators hypothesize that idelalisib may also be active in relapsed DLBCL, particularly of the GCB subtype. Possibly, the efficacy may be related to the presence of specific mutations within the B-cell receptor pathway.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Idelalisib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Idelalisib in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Idelalisib

Arm Intervention/treatment
Experimental: Treatment arm
Idelalisib 150 mg x 2 p o, until progression
Drug: Idelalisib
Idelalisib 150 mg x 2 p o




Primary Outcome Measures :
  1. Overall response rate for GCB DLBCL [ Time Frame: at time of progression, up to 112 weeks from start of treatment ]
    Overall response rate (ORR) for GCB DLBCL



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years.
  2. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) , including transformed low grade lymphoma, with either:

    1. Refractory disease: defined as disease progression while receiving their most recent prior cytotoxic chemotherapy (single-agent immunotherapy as maintenance is not considered cytotoxic therapy).
    2. Persistent disease: defined as stable disease or partial response at the completion of their most recent prior cytotoxic chemotherapy.
    3. Relapsed/recurrent disease: defined as complete response at the end of their most recent prior cytotoxic chemotherapy with subsequent relapse or disease recurrence.
  3. Subjects must have received prior rituximab and may have received up to 5 prior regimens containing cytotoxic chemotherapies.
  4. Subjects must not be candidates for high-dose chemotherapy with autologous stem cell support (ASCT), due to one or more of the following factors: relapse after high dose chemotherapy, age, comorbid disease, performance status, or persisting toxicities from prior chemotherapy.
  5. Absolute neutrophil count (ANC) >1.0 x 109/L, unless related to bone marrow infiltration.
  6. At least 1 measurable disease lesion that is >1.0 cm in 2 perpendicular dimensions, with the product diameter >2.25 cm2 by computed tomography (CT) or magnetic resonance imaging (MRI).
  7. Negative serum pregnancy test within 1 week before first treatment if the subject is a woman of childbearing potential. The use of highly-effective contraception methods* are required during the study for women of child-bearing potential. Due to the toxicity of idelalisib, women who will use a hormonal contraceptive must in addition also use a barrier method, since it is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
  8. WHO performance status 0 - 3.
  9. Written informed consent.

Exclusion Criteria:

  1. Prior allogeneic hematopoietic stem cell transplant (HSCT).
  2. Prior treatment with PI3K inhibitors.
  3. Serum total bilirubin ≥ 1.5 x ULN (unless elevated due to Gilbert's syndrome).
  4. Serum ALT and AST ˃ 2.5 x ULN.
  5. Estimated Creatinine Clearance < 10 ml/min.
  6. Known seropositivity for human immunodeficiency virus (HIV).
  7. Known history of drug induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver or portal hypertension.
  8. Known history of drug induced pneumonitis.
  9. On-going inflammatory bowel disease.
  10. Evidence of serious active infection (eg, requiring an intravenous [IV] antibiotic, antiviral, or antifungal agent), or subjects with a recent history of deep tissue infections such as fascitis or osteomyelitis.
  11. Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational drugs/devices <10 days before first dose of investigational product in this study. Subjects receiving high doses of corticosteroids must have been tapered to a stable dose at least 7 days before the first dose of investigational product.
  12. Pregnant or breastfeeding women.
  13. Symptomatic central nervous system (CNS) NHL; a lumbar puncture is not required unless CNS involvement with NHL is clinically suspected.
  14. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition).
  15. Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for >2 years.
  16. Previous myocardial infarction or pulmonary hypertension <6 months before first dose of investigational product.
  17. History of clinically significant ventricular arrhythmia, prolonged QTc interval or unexplained syncope.
  18. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.

Information from the National Library of Medicine

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): NCT03576443


Locations
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Denmark
Aarhus University Hospital
Aarhus C, Denmark, 8000
Odense University Hospital
Odense, Denmark
Sweden
Halmstad County Hospital
Halmstad, Sweden, 30 233
Linkoping University Hospital
Linköping, Sweden, 581 85
Skane University Hospital
Lund, Sweden, 221 85
Karolinska University Hospital
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Nordic Lymphoma Group
Investigators
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Principal Investigator: Mats Jerkeman Department of Oncology Skåne University Hospital
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Responsible Party: Nordic Lymphoma Group
ClinicalTrials.gov Identifier: NCT03576443    
Other Study ID Numbers: NLG-LBC-07
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Idelalisib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action