A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

July 1, 2019

Primary Completion Date

September 21, 2022

Study Completion Date

May 26, 2023

Conditions
LeukemiaPrecursor b-Cell Lymphoblastic Leukemia-LymphomaACUTE LYMPHOBLASTIC LEUKEMIA
Interventions
DRUG

inotuzumab ozogamicin-dose level 2

Inotuzumab ozogamicin (BESPONSA™) is a CD22 targeted antibody drug conjugate (ADC) approved by US FDA for treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). The approved starting dose is 1.8mg/m2/cycle. This treatment arm evaluates a lower starting dose of 1.2mg/m2/cycle.

DRUG

Inotuzumab ozogamicin-dose level 1

Inotuzumab ozogamicin (BESPONSA™) is a CD22 targeted antibody drug conjugate (ADC) approved by US FDA for treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). The approved starting dose of 1.8mg/m2/cycle is administered in this treatment arm.

Trial Locations (45)

500

Changhua Christian Hospital, Changhua

4032

Debreceni Egyetem Klinikai Központ, Orvosi Kepalkotó Klinika, Radiológia, Debrecen

Debreceni Egyetem Klinikai Központ, Pathológiai lntézet, Debrecen

4400

Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia, Nyíregyháza

10002

National Taiwan University Hospital, Taipei

21201

University of Maryland- Greenebaum Comprehensive Cancer Center, Baltimore

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

33011

Hospital Universitario Central de Asturias, Oviedo

34899

Marmara University Pendik Training and Research Hospital Hematology Unit, Istanbul

35100

Ege University Medical Faculty, Izmir

35340

Dokuz Eylul University Medical Faculty, Izmir

35575

Medicalpark Izmir Hospital, Izmir

38039

Erciyes Universitesi Tip Fakultesi Hastaneleri, Kayseri

41013

Hospital General - Semisótano, Seville

Hospital Universitario Virgen del Rocio, Seville

41400

Anadolu Health Center Hospital, Gebze

46010

Hospital Clinico Universitario de Valencia, Valencia

46026

Hospital Universitari i Politecnic La Fe, Valencia

55200

Ondokuz Mayis University Faculty Of Medicine Hospital, Samsun

60612

Rush University Medical Center, Chicago

90033

Keck Hospital of USC, Los Angeles

LAC+USC Medical Center, Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles

98195

University of Washington Medical Center, Seattle

119074

National University Hospital, Singapore

122001

Artemis hospital, Gurugram

188770

Raffles Hospital, Singapore

Raffles Radiology, Singapore

411004

Sahyadri Clinical Research and Development Centre, Pune

Sahyadri Super Speciality Hospital, Pune

411006

Sahyadri Super Speciality Hospital Nagar Road, Pune

Sahyadri Super Speciality Hospital, Pune

632004

Christian Medical College, Vellore

632517

Christian Medical College Vellore- Ranipet Campus, Ranipet - 632517, Tamil Nadu, India

98109-1028

Seattle Cancer Care Alliance, Seattle

80-214

Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne, Gdansk

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

50-367

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we Wroclawiu, Wroclaw

50-556

Apteka Centralna, Wroclaw

08035

Hospital Universitari Vall d'Hebron, Barcelona

06200

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Clinical Research Center, Ankara

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Hematology Department, Ankara

06590

Ankara University Faculty of Medicine Cebeci Hospital Hematology Department, Ankara

07050

Private Medstar Antalya Hosp. Hematology and Stem Cell Transplantation Center, Antalya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY