Study to Evaluate Loncastuximab Tesirine Versus Idelalisib in Patients with Relapsed or Refractory Follicular Lymphoma
- Conditions
- Relapsed or Refractory Follicular LymphomaMedDRA version: 21.1Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-003695-40-IT
- Lead Sponsor
- ADC THERAPEUTICS SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
1. Written informed consent must be obtained prior to any study procedures.
2. Male or female patients aged 18 years or older, with pathologic diagnosis of follicular lymphoma (Grade 1, 2, 3A) in the most recent tumor biopsy.
3. Relapsed or refractory disease following two or more treatment regimens, at least one of which must have contained an anti-CD20 therapy.
4.Patients who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19- directed therapy.
5. Measurable disease as defined by the 2014 Lugano Classification as assessed by positron emission tomography-computed tomography (PET CT) or, if not FDG-avid, CT or magnetic resonance imaging (MRI).
6. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available).
Note: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred.
7. ECOG performance status 0 to 2.
8. Adequate organ function as defined by screening laboratory values within the following parameters:
a. Absolute neutrophil count (ANC) =1.0 × 10^3/µL (off growth factors at least 72 hours),
b. Platelet count =75 × 10^3/µL without transfusion in the past 2 weeks,
c. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) =2.5 × the upper limit of normal (ULN),
d. Total bilirubin =1.5 × ULN (patients with known Gilbert's syndrome may have a total bilirubin up to =3×ULN).
e. Calculated creatinine clearance =30 mL/min by the Cockcroft and Gault equation.
Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility
9. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 6 months after the last dose of study treatment. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent until at least 6 months after the patient receives his last dose of study treatment.
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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
1. Previous treatment with loncastuximab tesirine.
2. Previous treatment with idelalisib.
3. Follicular lymphoma which has transformed to diffuse large B-cell
lymphoma (DLBCL) or other aggressive lymphoma.
4. Requires treatment or prophylaxis with a strong cytochrome P450
(CYP) 3A inhibitor, inducer, or sensitive substrate.
5. History of or ongoing drug-induced pneumonitis.
6. History of or ongoing inflammatory bowel disease.
7. Any condition that could interfere with the absorption or metabolism
of idelalisib including malabsorption syndrome, disease significantly
affecting gastrointestinal function, or resection of the stomach or small
bowel.
8. Active second primary malignancy other than non-melanoma skin
cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or
lobular carcinoma in situ of the breast, or other malignancy that the
Sponsor's medical monitor and Investigator agree and document should
not be exclusionary.
9. Autologous transplant within 30 days prior to start of study treatment
(C1D1).
10. Allogenic transplant within 60 days prior to start of study treatment
(C1D1).
11. Active graft-versus-host disease.
12. Post-transplantation lymphoproliferative disorders.
13. Human immunodeficiency virus (HIV) seropositive with any of the
following:
a. CD4+ T-cell counts <350 cells/µL.
b. Acquired immuno-deficiency syndrome (AIDS)-defining opportunistic
infection within 12 months prior to screening.
c. Not on anti-retroviral therapy, or on anti-retroviral therapy for <4
weeks at the time of screening.
d. HIV viral load =400 copies/mL.
14. Serologic evidence of chronic hepatitis B infection and unable or
unwilling to receive standard prophylactic anti-viral therapy or with
detectable hepatitis B virus (HBV) viral load.
15. Serologic evidence of hepatitis C infection without completion of
curative treatment or with detectable hepatitis C virus (HCV) viral load.
16. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
17. Lymphoma with active central nervous system involvement,
including leptomeningeal disease.
18. Clinically significant third space fluid accumulation (i.e., ascites
requiring drainage or pleural effusion that is either requiring drainage or
associated with shortness of breath).
19. Breastfeeding or pregnant.
20. Significant medical comorbidities, including but not limited to,
uncontrolled hypertension (BP =160/100 mm Hg repeatedly), unstable
angina, congestive heart failure (greater than New York Heart
Association class II), electrocardiographic evidence of acute ischemia,
coronary angioplasty or myocardial infarction within 6 months prior to
screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly
controlled diabetes, or severe chronic pulmonary disease.
21. Any Grade =3 active infection which requires IV antibiotics, IV
antiviral, or IV antifungal treatment.
22. Major surgery, radiotherapy, chemotherapy or other anti-neoplastic
therapy within 14 days prior to start of study treatment (C1D1), except
shorter if approved by the Sponsor.
23. Use of any other experimental medication within 30 days prior to
start of study treatment (C1D1).
24. Live vaccine administration within 4 weeks prior to Cycle 1 Day 1.
25. Failure to recover to =Grade 1 (Common Terminology Criteria for
Adverse Events [CTCAE] v5.0) from acute non-hematologic toxicity
(except = Grade 2 neuropathy or alopecia) due to previous therapy prior
to screening.
26. Any other significant medical illness, abnormali
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