Etude : XmAb13676-01 / XmAb 13676-01



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : XmAb13676-01

Nom : XmAb 13676-01

Traitement : Induction

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 24/01/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 in Patients With CD20-Expressing Hematologic Malignancies

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C85 - Lymphome non hodgkinien, de types autres et non précisés

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C91 - Leucémie lymphoïde
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Experimental: Non-CLL B Cell Malignancies (Group NHL)
XmAb13676 administered IV weekly up to 8 weeks
Experimental: CLL/SLL (Group CLL)
XmAb13676 administered IV weekly up to 8 weeks

Phase : I

Stade : NA

Rechute, Réfractaire
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : Able to provide written informed consent
Diagnosis of either Non-CLL B cell malignancy or CLL/SLL
Ineligible for or have exhausted standard therapeutic options
Last dose of anti-CD20 antibody therapy must have been >4 weeks before the first dose of XmAb13676
ECOG performance status 0-2
Not a candidate for or refusing treatment with hematopoietic stem cell transplantation
Fertile patients must agree to use effective contraception during and for 4 weeks after completion of study
Able and willing to complete the entire study

Critères de non-inclusion : Cytotoxic chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or small molecule or investigational agents within 6 elimination half-lives of the first dose of XmAb13676
Prior allogeneic stem cell or solid organ transplantation
Failure to recover from Grade 3 or 4 toxicity from previous treatment
Multiple myeloma/plasma cell leukemia or B cell acute lymphoblastic leukemia
Known intolerance to CD20 monoclonal antibody therapy
History of primary central nervous system lymphoma or neoplastic central nervous system disease
Platelet count < 50 x 10^9/L
Absolute neutrophil count < 1.0 x 10^9/L
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at screening > 3x upper limit of normal (ULN)
Bilirubin > 1.5 mg/dL
Estimated creatinine clearance < 50 mL/min
Active/uncontrolled autoimmune disease
Clinically significant cardiac/cardiovascular disease, or pulmonary compromise
Seizure disorder
History of stroke with the past year
History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion
Evidence of any serious bacterial, viral, parasitic or systemic fungal infections within the 30 days prior to study entry
Positive test for human immunodeficiency virus (HIV) or hepatitis C (HCV) antibodies (unless HCV viral load test by PCR is negative)
Positive test for HbsAg, or positive test for HBcAb (unless serology is positive due to recent intravenous immunoglobulin therapy). HBcAb positivity will be allowed if HBsAb is present.
Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the End of Study visit
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02924402
Promoteur :
Xencor, Inc.
Type de sponsor : Industriel
Monrovia, Californie, États-Unis -
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :
Hervé TILLY

TEC / ARC / IDE :
Justine LORET
justine.loret@
chb.unicancer.fr
02.32.08.30.45

Statut de l'essai : OUVERT

MAJ : 15/11/2019