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A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL

Primary Purpose

ACUTE LYMPHOBLASTIC LEUKEMIA

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Inotuzumab ozogamicin
ALLR3
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACUTE LYMPHOBLASTIC LEUKEMIA focused on measuring ALL, BCP ALL, High risk BCP ALL, Relapse ALL, Leukemia

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female participants between 1 and <18 years of age. Morphologically confirmed diagnosis of first relapse HR BCP ALL; HR first relapse is defined as relapse occurring within 18 to 30 months of original diagnosis of ALL or within 6 months of completion of primary therapy, and lacking any identified very high-risk genetic abnormalities (ie, KMT2A-rearrangements, TCF3-HLF, TCF3-PBX1, hypodiploidy, TP53 alteration) CD22-positive ALL as defined by local institution; Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status). Adequate serum chemistry parameters: An eGFR in participants 1 to <2 years of age, or eCrCl in those 2 to <18 years of age, ≥30 mL/min using the recommended formula in Section 10.10.2. AST and ALT ≤5 × institutional ULN at the time of randomization or pre-cytoreduction/general anesthesia; Total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome; Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines. Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction >50% by MUGA. 5.2. Exclusion Criteria Any history of prior or ongoing hepatic SOS or prior liver failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)]. Prior allo-HSCT or CAR T-cell therapy. Isolated extramedullary leukemia. Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present. Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin). Participants with active, uncontrolled bacterial, fungal, or viral infection.

Sites / Locations

  • UZ Gent
  • UZ Leuven
  • Cliniques Universitaires Saint-Luc
  • Detska nemocnice FN Brno
  • Fakultni nemocnice v Motole
  • Helsinki university hospital
  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
  • CHU Strasbourg-Hautepierre
  • Bordeaux University Hospital - Pellegrin
  • Hôpital Arnaud de Villeneuve - CHU Montpellier
  • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De NantesRecruiting
  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
  • Hôpital Jeanne de Flandre
  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo UniversitaRecruiting
  • Institut d'Hématologie et d'Oncologie Pédiatrique
  • Hôpital Armand Trousseau
  • CHRU De Rennes - Hôpital Sud
  • Universitaetsklinikum Tuebingen
  • Universitaetsklinikum Ulm
  • Universitaetsklinikum Wuerzburg
  • Universitätsklinikum Frankfurt Goethe-Universität
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Essen
  • Universitätsklinikum Münster - Albert Schweitzer Campus
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel
  • Charité Campus Virchow-Klinikum
  • Universitätsklinikum Gießen
  • Universitaetsklinikum Hamburg-Eppendorf
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Jena
  • Aghia Sophia Children's Hospital
  • Pécsi Tudományegyetem Klinikai Központ
  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
  • Semmelweis Egyetem
  • Schneider Children's Medical Center
  • The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric
  • Rambam Health Care Campus
  • Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
  • Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon
  • IRCCS Istituto Giannina Gaslini
  • Ospedale Pediatrico Bambino Gesù IRCCSRecruiting
  • Policlinico "G. Rodolico"
  • IRCCS - AOU di Bologna
  • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
  • Fondazione IRCCS Policlinico San Matteo
  • Ospedale Infantile Burlo Garofolo
  • Prinses Maxima Centrum voor Kinderoncologie
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy
  • Narodny ustav detskych chorob
  • CHUS - Hospital Clinico Universitario
  • Hospital Universitari Vall d'Hebron
  • Hospital Sant Joan de Déu
  • Hospital Infantil Universitario Niño Jesús
  • Hospital Clinico Universitario Virgen de la ArrixacaRecruiting
  • Hospital Universitario La Paz
  • CHUS - Hospital Clinico Universitario
  • Hospital Universitario Virgen Del RocioRecruiting
  • CHUV (centre hospitalier universitaire vaudois)
  • Kinderspital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inotuzumab ozogamicin

ALLR3

Arm Description

Each participant in the InO arm will receive 1 course (3 doses) of InO, as follows: Day 1: 0.8 mg/m2 Days 8 (±1 day) and Day 15 (±1 day): 0.5 mg/m2/dose

Mitoxantrone 10 mg/m2 on Days 1 and 2 Vincristine 1.5 mg/m2 (max single dose 2 mg) administered on Days 3, 10, 17 and 24 Dexamethasone 20 mg/m2/day administered orally (or IV) divided into two daily doses (maximum 40 mg/day) as two 5-day blocks on Days 1-5 and Days 15-19. PEG-asparaginase 1000 units/m2 IV administered on Days 3 and 17

Outcomes

Primary Outcome Measures

Minimum Residual Disease (MRD) Negativity in participants achieving complete response (CR), complete response with incomplete platelet count recovery (CRp), or complete response with incomplete count recovery (CRi)
MRD negativity status is determined based on the minimum MRD percentage between the date of CR/CRp/CRi and end of treatment test as assessed by RQ-PCR, with reflex to FC result if MRD is non-evaluable by RQ-PCR

Secondary Outcome Measures

Event Free Survival (EFS)
EFS will be summarized using Kaplan-Meier methods and displayed graphically by treatment arm.
Duration of Response (DoR) for Participants Who Achieved CR/CRp/CRi
DoR will be summarized using Kaplan-Meier methods.
Rate of hematopoietic stem cell transplantation (HSCT)
HSCT rate will be summarized by descriptive analyses (ie, percentage of participants who underwent HSCT after treatment).
Overall Survival (OS)
OS will be summarized by treatment arm using Kaplan-Meier methods.
Number of participants reporting an Adverse Event (AE)
The number and percentage of participants who experienced any AE, SAE (Serious Adverse Event), treatment related AE, and treatment related SAE will be summarized according to worst toxicity grades.
Pharmacokinetics (PK) parameter: InO Cmax
Descriptive summary statistics will be provided for InO serum concentrations at scheduled visits.
Number of Adverse Events (AE) reported by severity
AEs will be graded by the investigator according to the CTCAE (Common Terminology Criteria for Adverse Events) version 4.03.
Pharmacokinetics (PK) parameter: InO trough levels
Descriptive summary statistics will be provided for InO serum concentrations at scheduled visits.
Rate of Chimeric antigen receptor (CAR) T-cell therapy
CAR T-cell therapy rate will be summarized by descriptive analyses (ie, the number, percent of participants who underwent CAR T-cell therapy after treatment).

Full Information

First Posted
January 20, 2023
Last Updated
October 10, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05748171
Brief Title
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
Official Title
A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
July 11, 2028 (Anticipated)
Study Completion Date
July 11, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.
Detailed Description
This prospective, randomized, multicenter, open-label, Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3, after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with HR first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up for efficacy and safety will continue for up to 5 years from randomization. End of Treatment is defined as occurring upon recovery from 1 cycle of study therapy (Day 28 ± 2 days), or one day before initiation of new anticancer therapy, whichever occurs first. Approximately 100 participants will be randomized (2:1) to receive 1 cycle of either InO monotherapy or ALLR3 (block 1) therapy during induction. After completion of induction therapy (ie, study therapy), it is anticipated that the majority of responding participants will proceed immediately to consolidation therapy. Non-responders are expected to proceed with salvage therapy at the investigator's discretion. Participants responding to induction therapy are expected to proceed to SOC consolidation therapy upon recovery of blood counts, but no sooner than 7 days after last dose of study intervention. All participants (responders and non-responders) will proceed to long-term follow-up for this study. All subsequent anticancer therapy will be determined by the treating physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACUTE LYMPHOBLASTIC LEUKEMIA
Keywords
ALL, BCP ALL, High risk BCP ALL, Relapse ALL, Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized at 2:1 ratio, so that approximately 67 participants will receive InO and 33 participants will receive the comparator treatment regimen, ALLR3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inotuzumab ozogamicin
Arm Type
Experimental
Arm Description
Each participant in the InO arm will receive 1 course (3 doses) of InO, as follows: Day 1: 0.8 mg/m2 Days 8 (±1 day) and Day 15 (±1 day): 0.5 mg/m2/dose
Arm Title
ALLR3
Arm Type
Active Comparator
Arm Description
Mitoxantrone 10 mg/m2 on Days 1 and 2 Vincristine 1.5 mg/m2 (max single dose 2 mg) administered on Days 3, 10, 17 and 24 Dexamethasone 20 mg/m2/day administered orally (or IV) divided into two daily doses (maximum 40 mg/day) as two 5-day blocks on Days 1-5 and Days 15-19. PEG-asparaginase 1000 units/m2 IV administered on Days 3 and 17
Intervention Type
Drug
Intervention Name(s)
Inotuzumab ozogamicin
Other Intervention Name(s)
Besponsa
Intervention Description
Inotuzumab ozogamicin (BESPONSA™) is a CD22 targeted antibody drug conjugate (ADC) approved in several countries for the treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). The approved starting dose is 1.8mg/m2/cycle.
Intervention Type
Drug
Intervention Name(s)
ALLR3
Other Intervention Name(s)
R3
Intervention Description
The ALLR3 chemotherapy regimen (vincristine, mitoxantrone, dexamethasone, and asparaginase) has been adopted by pediatric oncology groups as treatment for pediatric relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL)
Primary Outcome Measure Information:
Title
Minimum Residual Disease (MRD) Negativity in participants achieving complete response (CR), complete response with incomplete platelet count recovery (CRp), or complete response with incomplete count recovery (CRi)
Description
MRD negativity status is determined based on the minimum MRD percentage between the date of CR/CRp/CRi and end of treatment test as assessed by RQ-PCR, with reflex to FC result if MRD is non-evaluable by RQ-PCR
Time Frame
After 1 treatment cycle: Day 28 +/- 2 days
Secondary Outcome Measure Information:
Title
Event Free Survival (EFS)
Description
EFS will be summarized using Kaplan-Meier methods and displayed graphically by treatment arm.
Time Frame
From study start to first event (progression, relapse, failure to achieve CR/CRp/CRi by the end of induction, MRD persistence prior to HSCT [hematopoietic stem cell transplant], second malignancy, or death): up to 5 years from randomization
Title
Duration of Response (DoR) for Participants Who Achieved CR/CRp/CRi
Description
DoR will be summarized using Kaplan-Meier methods.
Time Frame
From date of first response to date of first event (objective progression, relapse as determined by investigator assessment, MRD persistence prior to HSCT, or death due to any cause, whichever occurs first): up to 5 years from End of Treatment
Title
Rate of hematopoietic stem cell transplantation (HSCT)
Description
HSCT rate will be summarized by descriptive analyses (ie, percentage of participants who underwent HSCT after treatment).
Time Frame
Up to 5 years from randomization
Title
Overall Survival (OS)
Description
OS will be summarized by treatment arm using Kaplan-Meier methods.
Time Frame
From start of treatment to date of death due to any cause: up to 5 years from randomization
Title
Number of participants reporting an Adverse Event (AE)
Description
The number and percentage of participants who experienced any AE, SAE (Serious Adverse Event), treatment related AE, and treatment related SAE will be summarized according to worst toxicity grades.
Time Frame
From time of informed consent up to a minimum of 60 calendar days after the last dose of study drug.
Title
Pharmacokinetics (PK) parameter: InO Cmax
Description
Descriptive summary statistics will be provided for InO serum concentrations at scheduled visits.
Time Frame
1 treatment cycle: 28 days
Title
Number of Adverse Events (AE) reported by severity
Description
AEs will be graded by the investigator according to the CTCAE (Common Terminology Criteria for Adverse Events) version 4.03.
Time Frame
From time of informed consent up to a minimum of 60 calendar days after the last dose of study drug.
Title
Pharmacokinetics (PK) parameter: InO trough levels
Description
Descriptive summary statistics will be provided for InO serum concentrations at scheduled visits.
Time Frame
1 treatment cycle: 28 days
Title
Rate of Chimeric antigen receptor (CAR) T-cell therapy
Description
CAR T-cell therapy rate will be summarized by descriptive analyses (ie, the number, percent of participants who underwent CAR T-cell therapy after treatment).
Time Frame
Up to 5 years from randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participants between 1 and <18 years of age. Morphologically confirmed diagnosis of first relapse HR BCP ALL; HR first relapse is defined as relapse occurring within 18 to 30 months of original diagnosis of ALL or within 6 months of completion of primary therapy, and lacking any identified very high-risk genetic abnormalities (ie, KMT2A-rearrangements, TCF3-HLF, TCF3-PBX1, hypodiploidy, TP53 alteration) CD22-positive ALL as defined by local institution; Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status). Adequate serum chemistry parameters: An eGFR in participants 1 to <2 years of age, or eCrCl in those 2 to <18 years of age, ≥30 mL/min using the recommended formula in Section 10.10.2. AST and ALT ≤5 × institutional ULN at the time of randomization or pre-cytoreduction/general anesthesia; Total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome; Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines. Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction >50% by MUGA. 5.2. Exclusion Criteria Any history of prior or ongoing hepatic SOS or prior liver failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)]. Prior allo-HSCT or CAR T-cell therapy. Isolated extramedullary leukemia. Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present. Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin). Participants with active, uncontrolled bacterial, fungal, or viral infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
UZ Gent
City
Gent
State/Province
Oost-vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Detska nemocnice FN Brno
City
Brno
State/Province
Brno-město
ZIP/Postal Code
613 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Fakultni nemocnice v Motole
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Helsinki university hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06202
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU Strasbourg-Hautepierre
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67098
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Bordeaux University Hospital - Pellegrin
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Arnaud de Villeneuve - CHU Montpellier
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34090
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes
City
Nantes
State/Province
Loire-atlantique
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
City
Vandoeuvre lès Nancy
State/Province
Meurthe-et-moselle
ZIP/Postal Code
54511
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Jeanne de Flandre
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
City
Paris Cedex 19
State/Province
Paris
ZIP/Postal Code
75935
Country
France
Individual Site Status
Recruiting
Facility Name
Institut d'Hématologie et d'Oncologie Pédiatrique
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Armand Trousseau
City
Paris
ZIP/Postal Code
75571
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHRU De Rennes - Hôpital Sud
City
Rennes
ZIP/Postal Code
35203
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Tuebingen
City
Tübingen
State/Province
Baden-württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden-württemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Wuerzburg
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Frankfurt Goethe-Universität
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-westfalen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Münster - Albert Schweitzer Campus
City
Münster
State/Province
Nordrhein-westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
State/Province
Schleswig-holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Gießen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Aghia Sophia Children's Hospital
City
Athens
State/Province
Attikí (region)
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7623
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
City
Miskolc
State/Province
Borsod-abaúj-zemplén
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Schneider Children's Medical Center
City
Petah-Tikva
State/Province
Hamerkaz
ZIP/Postal Code
49202
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric
City
Ramat Gan
State/Province
Hamerkaz
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
State/Province
Hatsafon
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
City
Tel Aviv
State/Province
Tell Abīb
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon
City
Napoli
State/Province
Campania
ZIP/Postal Code
80123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Istituto Giannina Gaslini
City
Genova
State/Province
Liguria
ZIP/Postal Code
16147
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale Pediatrico Bambino Gesù IRCCS
City
Rome
State/Province
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico "G. Rodolico"
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS - AOU di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale Infantile Burlo Garofolo
City
Trieste
ZIP/Postal Code
34137
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Prinses Maxima Centrum voor Kinderoncologie
City
Utrecht
ZIP/Postal Code
3584 CS
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-094
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Narodny ustav detskych chorob
City
Bratislava
State/Province
Bratislavský KRAJ
ZIP/Postal Code
833 40
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
A Coruña [LA Coruña]
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Sant Joan de Déu
City
Esplugues de Llobregat
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Infantil Universitario Niño Jesús
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clinico Universitario Virgen de la Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
CHUV (centre hospitalier universitaire vaudois)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Kinderspital Zürich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B1931036
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL

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