Follicular Lymphoma MedDRA version: 9.1 Level: LLT Classification code 10029473 Term: Nodular (follicular) lymphoma
Conditions
Interventions
Product Name: IPH1101 ou Phosphostim 200
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 876060-87-6
Current Sponsor code: IPH1101
Other descriptive name: bromohydrin pyrophosphate (
Sponsors
Innate Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any protocol-specific procedures, 2. Histologicy documented diagnosis of follicular non-Hodgkin’s lymphoma, 3. Follicular lymphoma of grade 1 or 2 (WHO [World Health Organisation] classification), Note: 3a patients will also be allowed, but only if the absence of transformation to high grade lymphoma was documented by a lymph-node biopsy done at Screening. 4. Progression after one, two, three or four previous line(s) of therapy, 5. At least one but not more than two of the prior line(s) of therapy must have been a rituximab-containing treatment, 6. At least 4 weeks from Screening since previous systemic anti-cancer therapy, including steroids, 7. Interval at Screening from last administration of previous systemic therapy for fludarabin-, rituximab- or ibritumomab tiuxetan-containing therapies, or autologous therapy with auto transplantation: - 6 months in case of fludarabine-containing treatment or autologous therapy with auto transplantation, - 6 months in case of rituximab-containing chemotherapy or ibritumomab tiuxetan, - maintenance therapy accepted, with the same 6-month clearance period. 8. Measurable disease evaluable by Cheson et al. 1999 criteria 2 9. At least 2 weeks from Screening since previous surgery, 10. Aged > 18 years and = 75 years, 11. Eastern Cooperative Oncology Group (ECOG) performance status = 1 (i.e. 0, or 1), 12. Adequate bone marrow, hepatic and renal function as follows: - White blood cells (WBC) = 3.5 x 109/L, neutrophils = 1 x109/L, lymphocytes > 1 x 109/L, - Platelets = 60 x 109/L, - Haemoglobin = 8 g/dL or 5.6 mmol/L, - Total bilirubin = 2 x upper limit normal (ULN) and transaminases (alanine amino transferase / serum glutamic pyruvic transaminase [ALT / SGPT]; aspartate amino transferase /serum glutamic oxalo-acetic transaminase [AST / SGOT]) = 3 x ULN, OR if liver metastases, total bilirubin and transaminases = 5 x ULN, - Serum creatinine = 2 x ULN, - Alkaline Phosphatase (ALP) = 3 x ULN, 13. Electrocardiogram (ECG) QTc interval duration 12 weeks. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any mass > 7 cm, 2. Pleural or peritoneal effusion, 3. Non easily measurable disease such as: isolated - mesenteric panniculitis, - bone marrow infiltration, - bone lytic lesion, - epiduritis, - cutaneous follicular lymphoma. 4. LDH > ULN, Note: patients with LDH > ULN from 1.0 to 2.0 ULN will also be allowed, but only if the absence of transformation to high grade lymphoma was documented by a lymph-node biopsy performed at Screening. 5. Transformation to high grade lymphoma (secondary to low grade lymphoma), Note: If the investigator suspects transformation by clinical examination, a repeat lymph-node biopsy will be required prior to enrolment to document the absence of transformation. 6. Pregnant or lactating women, 7. Human immuno-deficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) positive serology at Screening, 8. Concurrent treatment with any other anti-cancer therapy or with other experimental drugs, participation in another clinical study with any investigative drug within 30 days prior to study Screening, 9. Concurrent treatment with: - biphosphonates, - immunosuppressive agents, - anticancer hormonal therapy, - systemic and chronic inhaled steroids, - beta-blockers and calcium channel blockers. 10. Prior history of high-dose chemotherapy followed by allogenic bone marrow or peripheral stem cell support/transplant, or presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to study Screening), 11. Prior history of mini-allogenic bone marrow transplantations, 12. Any known hypersensitivity to one of the study treatments, 13. Current active infection; serious concurrent, uncontrolled medical disorder such as diabetes, autoimmune disease, etc (at investigator’s discretion), 14. Cardiovascular disease: - Stage III or IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure. Note: patients with NYHA stage I or II CHF may be included provided they do not have arrhythmia requiring treatment or fulfil any other exclusion criteria. - Myocardial infarction within the previous 6 months, or - Symptomatic cardiac arrhythmia requiring treatment, 15. Left ventricular ejection fraction < 45% (as assessed by Multiple Gated Acquisition Scan [MUGA scan] or cardiac ultrasonography), 16. History of another malignancy within the past 5 years, except basal cell carcinoma of the skin or in situ cervix carcinoma, 17. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before requesting for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the clinical efficacy of IPH1101 (with low-dose IL 2, as aldesleukin), administered in combination with a standard course of rituximab, in patients with Follicular Lymphoma having relapsed after at least one prior rituximab-containing line.;Secondary Objective: - Evaluate other clinical efficacy parameters, - Evaluate the biological activity of IPH1101 (with low-dose aldesleukin) in this schedule and setting, - Investigate the relationship between biological activity and clinical efficacy, - Determine the safety of IPH1101 (with low dose aldesleukin) in this schedule and setting, - Evaluate the in vitro response to BrHPP stimulation of Vgamma9Vdelta2 human T lymphocytes (gamma delta T cells) from patients progressing after rituximab therapy and to explore its potential relationship with biological activity and clinical efficacy.;Primary end point(s): The primary endpoint will be the overall response rate (ORR), measured during the 24 weeks of study. The primary efficacy analysis will be performed on the population of evaluable patients, and also, among a sub-population of evaluable patients who have a greater than two-fold gamma delta T cells in vivo amplification rate (including patients of the group of the Phase I like period having received the same doses as patients of Period 2). | — |
Countries
Belgium, Germany
Outcome results
None listed