Phase 1b trial evaluating idelalisib in children and adolescents with relapsed or refractory diffuse large B-cell lymphoma or mediastinal B-cell lymphoma in combination with RICE
- Conditions
- B-cell malignanciesMedDRA version: 20.0Level: PTClassification code 10036714Term: Primary mediastinal large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001468-39-BE
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
1) Male or female subjects 1 to less than 18 years of age
2) Histologically confirmed diagnosis of DLBCL, or MBCL established by the World Health Organization 2008 classification of tumors of hematopoietic and lymphoid tissues
3) Relapsed or refractory DLBCL or MBCL
a) Refractory disease is defined as a < 50% decrease in lesion size with first-line therapy.
b) Relapsed reflects progressive disease or the appearance of new lesions after attainment of complete or partial remission.
c) Subjects who fail first line therapy may be categorized into 3 distinct groups: those who relapsed after complete remission, partial response with persistent disease and refractory.
4) Measurable or evaluable disease based on imaging, bone marrow examination.
5) Karnofsky = 60% for patients > 16 years of age or Lansky = 60 for patients = 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
6) A negative serum pregnancy test is required for female subjects of child bearing potential.
7) Male subjects and female subjects of child bearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 5 of the protocol.
8) Lactating females must agree to discontinue nursing before idelalisib is administered
9) Adequate bone marrow function defined as:
a) For subjects without bone marrow involvement:
o Peripheral absolute neutrophil count (ANC) = 1,000/µL, in the absence of growth factors
o Platelet count = 100,000/µL (transfusion independent)
o Hemoglobin = 8.0 gm/dL (RBC transfusion independent)
b) For subjects with bone marrow involvement (requires BM documentation):
o Platelet count = 20,000/µL (may receive platelet transfusions or thrombopoietic growth factors)
o Hemoglobin = 8.0 gm/dL (may receive RBC transfusions or erythropoietic growth factors)
10) Adequate renal function defined as: Estimated creatinine clearance (CrCL) = 70 mL/min/1.73m2 (using the Schwartz formula; =k x L/sCr) ([k is proportionality constant: for children 1-12 years old or adolescent females = 12 years old, k=0.55, and for adolescent males = 12 years old, k=0.70]; L is height in centimeters [cm]; and sCr is serum creatinine [mg/dL])
11) Parent/legal guardian must provide written informed consent prior to screening evaluations.
Subject will provide assent/consent if applicable.
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1) Prior PI3K inhibitor therapy
2) Prior ICE therapy, with or without an anti-CD20 antibody, or history of hypersensitivity to any components of RICE
3) Disease progression within 6 months from last anti-CD20 therapy
4) Ongoing toxicity from prior cytotoxic therapy (last dose at least 3 weeks prior to study entry)
5) Less than 4 half-lives from the last dose of previous targeted therapy and ongoing acute toxicity of prior targeted therapy
6) Known active central nervous system or leptomeningeal lymphoma or within 4 weeks from the last intrathecal therapy prior to the required diagnostic LP for this study
7) Active infection with HIV, HBV, HCV or CMV based on screening serology and PCR results
8) Evidence of uncontrolled systemic bacterial, fungal, or viral infection at the time of treatment start (Day 1)
9) Ongoing or history of drug-induced pneumonitis
10) Ongoing or history of inflammatory bowel disease
11) Pregnancy or breastfeeding
12) Currently receiving other anti-cancer agents or other investigational drug
13) Prior solid organ transplantation
14) Prior allogeneic stem cell transplantation within 60 days or active acute graft versus host disease (GVHD) grade 3 or higher (see Appendix 6 for GVHD grading)
15) Known hypersensitivity to idelalisib, the metabolites, or formulation excipients
16) Urinary outflow obstruction or inflammation of the urinary bladder (cystitis)
17) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method