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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001557-27 | EudraCT Number |
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This study will explore 2 different doses of inotuzumab ozogamicin including the dose that is approved and a lower dose. The main purpose of this study is to evaluate whether a dose of inotuzumab ozogamicin, lower than the approved dose, could be recommended for adult patient with relapsed or refractory ALL who may be at higher risk for severe liver problems after inotuzumab ozogamicin treatment and stem cell transplant (a potentially curative therapy that can replace cancer cells with healthy cells). Efficacy and safety of the 2 doses will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 2 | Experimental | Inotuzumab ozogamicin at starting dose 1.2 mg/m2/cycle (administered in 3 divided doses). Most patients expected to receive 2 or 3 cycles (cycle length 21 to 28 days) |
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| Dose Level 1 | Active Comparator | Inotuzumab ozogamicin at starting dose 1.8 mg/m2/cycle (administered in 3 divided doses). Most patients expected to receive 2 or 3 cycles (cycle length 21 to 28 days) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inotuzumab ozogamicin-dose level 2 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Veno-occlusive Disease (VOD) | VOD happened when the small blood vessels that lead into the liver and were inside the liver become blocked. VOD is defined as: a. Classical VOD (first 21 days after HSCT): Bilirubin>=2 mg/dL and 2 (or more) of the following criteria must also be present: 1. Painful hepatomegaly; 2. Weight gain >5%; 3. Ascites. b. Late onset VOD (>21 days after HSCT): Classical VOD beyond Day 21; or Histologically proven VOD; or Two or more of the following criteria must be present: 1. Bilirubin >2 mg/dL; 2. Painful hepatomegaly; 3. Weight gain >5%; 4. Ascites. and hemodynamical and/or ultrasound evidence of VOD. | 2 years from randomization |
| Rate of Hematologic Remission (Complete Response [CR] / Complete Response With Incomplete Hematologic Recovery[CRi]) | CR is defined as a disappearance of leukemia as indicated by<5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC)>=1000/µL and platelets>=100000/µL. C1 extramedullary disease status is required. CRi is defined as CR except with ANC <1000/µL and/or platelets <100000/µL. C1 defined as complete disappearance of all measurable and non-measurable extramedullary disease with the exception of lesions with following must be true: For participants with>= 1 measurable lesion, all nodal masses>1.5cm in greatest transverse diameter (GTD) at baseline (last assessment before 1st dose of study treatment) must must have regressed to>=1.5cm in GTD and all nodal masses>=1cm & <=1.5cm in GTD at baseline have regressed to <1cm GTD or must have reduced by 75% in sum of products of greatest diameters. No new lesions. Spleen and other previously enlarged organs must have regressed in size and must not be palpable. | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Adverse event (AE) = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. On-treatment period was defined as the period starting with the 1st dose of study treatment through 63 days after last dose or 1 day before start day of new anticancer therapy, whichever occurred first. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All VOD cases were reported as SAE. Grades of severity were defined by Common terminology criteria for adverse events (CTCAE) v3.0. Grade 3=severe adverse event; Grade 4=life-threatening consequences; urgent intervention indicated. Grade 5=death related to AE. Results were reported as of the data cutoff date on 21 Sep 2022. |
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Inclusion Criteria:
Relapsed or refractory precursor CD22 positive B cell ALL with M2 or M3 marrow (≥5% blasts) and who are eligible for HSCT;
Have 1 or more of the following risk factors for developing VOD:
Ph+ ALL patients must have failed treatment with at least 1 second or third generation tyrosine kinase inhibitor and standard multi agent induction chemotherapy;
Patients in Salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy;
Patients with lymphoblastic lymphoma and bone marrow involvement 5% lymphoblasts by morphologic assessment;
Age 18 years to 75 years;
Eastern Cooperative Oncology Group (ECOG) performance status 0 2;
Adequate liver function, including total serum bilirubin ≤1.5 x ULN unless the patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase (AST and ALT) ≤2.5 x ULN;
Serum creatinine ≤1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of >=40 mL/min;
Male and female patients of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for a minimum of 8 months (females) and 5 months (males) after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the Investigator, he/she is biologically capable of having children and is sexually active. Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study; patients with mental capacity which requires the presence of a legally authorized representative will be excluded from the study;
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
Isolated extramedullary relapse (ie, testicular or central nervous system);
Burkitt's or mixed phenotype acute leukemia based on the WHO 2008 criteria;
Active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS directed local treatment for active disease within the prior 28 days, symptomatic CNS leukemia (ie, cranial nerve palsies or other significant neurologic dysfunction) within 28 days. Prophylactic intrathecal medication is not a reason for exclusion;
Prior chemotherapy within 2 weeks before randomization with the following exceptions:
Patients must have recovered from acute non hematologic toxicity (to Grade 1 or less) of all previous therapy prior to enrollment.
Prior monoclonal antibodies within 6 weeks of randomization, with the exception of rituximab which must be discontinued at least 2 weeks prior to randomization;
Prior inotuzumab ozogamicin treatment or other anti CD22 immunotherapy within 6 months before randomization;
Prior allogeneic hematopoietic stem cell transplant (HSCT) within 90 days before randomization. Patients must have completed immunosuppression therapy for treatment of graft versus host disease (GvHD) prior to enrollment. At randomization, patients must not have Grade 2 or higher acute GvHD, or extensive chronic GvHD;
Peripheral absolute lymphoblast count >=10,000 /L (treatment with hydroxyurea and/or steroids/vincristine is permitted within 2 weeks of randomization to reduce the white blood cell [WBC] count);
Known systemic vasculitides (eg, Wegener's granulomatosis, polyarteritis nodosa, systemic lupus erythematosus), primary or secondary immunodeficiency (such as human immunodeficiency virus [HIV] infection or severe inflammatory disease);
Active hepatitis B infection as evidenced by hepatitis B surface antigen, active hepatitis C infection (must be anti-hepatitis C antibody negative or hepatitis C ribonucleic acid negative), or known seropositivity for HIV. HIV testing may need to be performed in accordance with local regulations or local practice;
Major surgery within 4 weeks before randomization;
Unstable or severe uncontrolled medical condition (eg, unstable cardiac function or unstable pulmonary condition);
Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been definitely treated with radiation or surgery. Patients with previous malignancies are eligible provided that they have been disease free for >=2 years;
Patients with active heart disease or the presence of New York Heart Association (NYHA) stage III or IV congestive heart failure;
QTcF >470 msec (based on the average of 3 consecutive electrocardiogram [ECGs]);
Myocardial infarction within 6 months before randomization;
History of clinically significant ventricular arrhythmia, or unexplained syncope not believed to be vasovagal in nature, or chronic bradycardic states such as sinoatrial block or higher degrees of atrioventricular (AV) block unless a permanent pacemaker has been implanted;
Uncontrolled electrolyte disorders that can compound the effects of a QTc prolonging drug (eg, hypokalemia, hypocalcemia, hypomagnesemia);
Prior confirmed or ongoing hepatic veno occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS), or other serious or current ongoing liver disease such as cirrhosis or nodular regenerative hyperplasia;
Administration of live vaccine within 6 weeks before randomization;
Evidence of uncontrolled current serious active infection (including sepsis, bacteremia, fungemia) or patients with a recent history (within 4 months) of deep tissue infections such as fascitis or osteomyelitis;
Patients who have had a severe allergic reaction or anaphylactic reaction to any humanized monoclonal antibodies;
Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use highly effective contraception as outlined in this protocol for the duration of the study and for a minimum of 8 months (females) and 5 months (males) after the last dose of investigational product;
Investigative site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study;
Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation (up through the end of treatment visit);
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Hospital of USC | Los Angeles | California | 90033 | United States | ||
| LAC+USC Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35622074 | Derived | Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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A total of 102 were enrolled. In Run-in Phase, 22 participants were enrolled and treated. In Randomized Phase, 80 participants were enrolled and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2018 | Sep 18, 2023 |
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The study will be conducted in 2 phases: a run in phase and a randomized phase.
Run in phase: a total of up to 22 patients will be enrolled to receive the starting dose of 1.2 mg/m2/cycle (dose level 2). A Simon Two Stage optimal design will be used. If acceptable efficacy (CR/CRi and MRD negativity) is observed in the run in phase, the study will enter the randomized phase.
Randomized phase: if acceptable efficacy is observed in the run in phase, the study will enter the randomized phase. A total of approximately 80 patients will be randomized (1:1) to 1 of 2 dose levels of inotuzumab ozogamicin (40 patients per dose level).
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| Inotuzumab ozogamicin-dose level 1 | Drug | 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. |
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| From first dose of study treatment drug through 63 days after last dose (approximately 52 weeks) |
| Number of Participants With Treatment-Emergent Adverse Events (Treatment-related) | Adverse event (AE) = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Treatment emergent AEs (TEAEs) were defined as AEs that reported the period starting with the first dose of study treatment drug through 63 days after last dose or 1 day before start day of new anticancer therapy, whichever occurred first. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grades of severity were defined by CTCAE v3.0. Grade 3 = severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE. Causality of TEAEs were assessed by the Investigator. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment drug through 63 days after last dose (approximately 52 weeks) |
| Number of Participants With Treatment-Emergent Serious Adverse Events (Post-HSCT) | A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All SAEs occurred after HSCT were reported in this OM. Results were reported as of the data cutoff date on 21 Sep 2022. | Starting from the first transplant after inotuzumab ozogamicin treatment and including the entire duration of subsequent follow up (approximately 52 weeks)) |
| Shift Summary of Hematology Laboratory Test Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline | Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Following Parameters were analyzed for laboratory assessment: Hematology (Activated partial thromboplastin time prolonged, Anemia, Hemoglobin increased, International normalization rate (INR) increased, Leukocytosis, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, White blood cell decreased). Grades of severity were defined by CTCAE v3.0. Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment drug through 63 days after last dose (approximately 52 weeks) |
| Shift Summary of Chemistry Laboratory Test Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline | Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Following Parameters were analyzed for laboratory assessment: Chemistry (Alanine aminotransferase increased, Alkaline phosphatase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Chronic kidney disease, Creatinine increased, Gamma glutamyl transpeptidase (GGT) increased, Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypermagnesemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hypomagnesemia, Hyponatremia, Hypophosphatemia, Lipase increased and Serum amylase increased). Grades of severity were defined by CTCAE v3.0. Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment drug through 63 days after last dose (approximately 52 weeks) |
| Number of Participants Achieving a CR/CRi With Minimal Residual Disease (MRD) Negativity | MRD was assessed by flow cytometry for CD22 and other cell surface markers associated with B-cell ALL. In participants who achieved CR/CRi, MRD negativity was defined as defined as <1 abnormal cell/10^4 nucleated cells by flow cytometry per central laboratory analysis. | At screening, once at Day 16-28 of Cycles 1 and 2, or until CR/CRi and MRD negativity were achieved, then after every 1-2 cycles as clinically indicated, and at EOT visit (maximum of 2.5 years) |
| Duration of Remission (DoR) in Participants Achieving CR/CRi | DoR was defined as time from date of first response in responders (CR/CRi) to the date of disease progression (i.e., objective progression, relapse from CR/CRi, including post-study treatment follow-up disease assessments) or death due to any cause, whichever occurs first. DoR was estimated using Kaplan-Meier methods. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
| Progression-Free Survival | PFS was defined as time from date of randomization to the date of disease progression (i.e., objective progression, relapse from CR/CRi, including post-study treatment follow-up disease assessments), death due to any cause, or starting new induction therapy/post-therapy HSCT without achieving CR/CRi, whichever occured first. PFS was estimated using Kaplan-Meier methods. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
| Overall Survival | Overall survival was defined as the time from date of first dose of study treatment to death due to any cause. Participants without confirmation of death were censored at the date that the participant was last known to be alive. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
| Number of Participant Received HSCT Post Inotuzumab Ozogamicin Treatment | Participants who underwent HSCT after inotuzumab ozogamicin treatment. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
| The Cumulative Incidence Rate of Post-HSCT Relapse at Month 12 | Post-HSCT relapse is defined as the time from date of first HSCT after inotuzumab ozogamicin treatment to the date of first relapse post-HSCT. Cumulative incidence rates of an event at a particular timepoint were estimated with the CI calculated based on the cumulative incidence function using the method described by Kalbfleisch RL and Prentice JD. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment to Month 12 |
| Number of Participants With Post-HSCT Mortality | Post-HSCT Mortality was defined as the time from date of first HSCT after inotuzumab ozogamicin treatment to death due to any cause. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
| Number of Participants With Post HSCT Non-Relapse Mortality | Post HSCT non-relapse mortality was defined as time from date of first HSCT after inotuzumab ozogamicin treatment to death due to any cause without prior relapse. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
| Number of Participants With Post HSCT Relapse-Related Mortality | Post HSCT Relapse-Related Mortality was defined as time from date of first HSCT after inotuzumab ozogamicin treatment to death due to any cause with prior relapse. Results were reported as of the data cutoff date on 21 Sep 2022. | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
| Mean Predose Concentrations (Ctrough) of Inotuzumab Ozogamicin | Ctrough was defined as the mean Predose concentration of study treatment. | Pre-dose on Cycle 1 Day 1, 8 and 15, and on Day1 and 8 of Cycle 2, 3 and 4. |
| Number of Participants With Positive Anti-Drug Antibody (ADA) | ADA incidence is defined as combined results of treatment-boosted and treatment-induced ADA-positive participants. The immunogenicity of inotuzumab ozogamicin was evaluated using a validated electrochemiluminescence (ECL)-based immunoassay. | At Day 1 of every cycle prior to the beginning of inotuzumab ozogamicin infusion and at the EOT visit, up to approximately 52 weeks. |
| Number of Participants With Positive Neutralizing Antibody (NAb) | NAb incidence is defined as combined results of treatment-boosted and treatment-induced NAb-positive participants. The immunogenicity of inotuzumab ozogamicin was evaluated using a validated electrochemiluminescence (ECL)-based immunoassay. | At Day 1 of every cycle prior to the beginning of inotuzumab ozogamicin infusion and at the EOT visit, up to approximately 52 weeks. |
| Los Angeles |
| California |
| 90033 |
| United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Maryland- Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1028 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Debreceni Egyetem Klinikai Központ, Orvosi Kepalkotó Klinika, Radiológia | Debrecen | 4032 | Hungary |
| Debreceni Egyetem Klinikai Központ, Pathológiai lntézet | Debrecen | 4032 | Hungary |
| Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia | Nyíregyháza | 4400 | Hungary |
| Artemis hospital | Gurugram | Haryana | 122001 | India |
| Sahyadri Clinical Research and Development Centre | Pune | Maharashtra | 411004 | India |
| Sahyadri Super Speciality Hospital | Pune | Maharashtra | 411004 | India |
| Sahyadri Super Speciality Hospital Nagar Road | Pune | Maharashtra | 411006 | India |
| Sahyadri Super Speciality Hospital | Pune | Maharashtra | 411006 | India |
| Christian Medical College | Vellore | Tamil Nadu | 632004 | India |
| Christian Medical College Vellore- Ranipet Campus | Ranipet - 632517, Tamil Nadu, India | 632517 | India |
| Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Instytut Hematologii i Transfuzjologii | Warsaw | 02-776 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we Wroclawiu | Wroclaw | 50-367 | Poland |
| Apteka Centralna | Wroclaw | 50-556 | Poland |
| National University Hospital | Singapore | 119074 | Singapore |
| Raffles Hospital | Singapore | 188770 | Singapore |
| Raffles Radiology | Singapore | 188770 | Singapore |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital General - Semisótano | Seville | 41013 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Changhua Christian Hospital | Changhua | 500 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Anadolu Health Center Hospital | Gebze | Istanbul | 41400 | Turkey (Türkiye) |
| Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Clinical Research Center | Ankara | 06200 | Turkey (Türkiye) |
| Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Hematology Department | Ankara | 06200 | Turkey (Türkiye) |
| Ankara University Faculty of Medicine Cebeci Hospital Hematology Department | Ankara | 06590 | Turkey (Türkiye) |
| Private Medstar Antalya Hosp. Hematology and Stem Cell Transplantation Center | Antalya | 07050 | Turkey (Türkiye) |
| Marmara University Pendik Training and Research Hospital Hematology Unit | Istanbul | 34899 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35100 | Turkey (Türkiye) |
| Dokuz Eylul University Medical Faculty | Izmir | 35340 | Turkey (Türkiye) |
| Medicalpark Izmir Hospital | Izmir | 35575 | Turkey (Türkiye) |
| Erciyes Universitesi Tip Fakultesi Hastaneleri | Kayseri | 38039 | Turkey (Türkiye) |
| Ondokuz Mayis University Faculty Of Medicine Hospital | Samsun | 55200 | Turkey (Türkiye) |
| FG001 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized Phase) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle administrated in 3 divided doses (0.8 mg/m² on Day 1, 0.5 mg/m² on Days 8 and 15) intravenously. After CR/CRi was achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Days 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
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| NOT COMPLETED |
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The full analysis set included all participants who were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle administrated in 3 divided doses (0.6 mg/m² on Day1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete response (CR)/complete remission with incomplete hematologic recovery (CRi) was achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Days 1, 8 and 15). The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
| BG001 | 1.2 mg/m²/Cycle (Dose Level 2 Randomized Phase) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle administrated in 3 divided doses (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After CR/CRi was achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Days 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
| BG002 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized Phase) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle administrated in 3 divided doses (0.8 mg/m² on Day 1, 0.5 mg/m² on Days 8 and 15) intravenously. After CR/CRi was achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Days 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| ECOG Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status is defined as: ECOG=0: Fully active, able to carry on all predisease performance without restriction; ECOG=1: Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, ie, light house work, office work; ECOG=2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. | Count of Participants | Participants |
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| Body Mass Index (BMI) | BMI (kg/m^2) was computed as Height (cm)/Weight (kg) x 100. | Median | Full Range | kg/m^2 |
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| Body Surface Area (BSA) | BSA (m^2) will be computed using Du Bois Formula: 0.007184 x Weight (kg)^0.425 x Height (cm)^0.725. | Median | Full Range | m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Veno-occlusive Disease (VOD) | VOD happened when the small blood vessels that lead into the liver and were inside the liver become blocked. VOD is defined as: a. Classical VOD (first 21 days after HSCT): Bilirubin>=2 mg/dL and 2 (or more) of the following criteria must also be present: 1. Painful hepatomegaly; 2. Weight gain >5%; 3. Ascites. b. Late onset VOD (>21 days after HSCT): Classical VOD beyond Day 21; or Histologically proven VOD; or Two or more of the following criteria must be present: 1. Bilirubin >2 mg/dL; 2. Painful hepatomegaly; 3. Weight gain >5%; 4. Ascites. and hemodynamical and/or ultrasound evidence of VOD. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | Percentage of Participants | 2 years from randomization |
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| Primary | Rate of Hematologic Remission (Complete Response [CR] / Complete Response With Incomplete Hematologic Recovery[CRi]) | CR is defined as a disappearance of leukemia as indicated by<5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC)>=1000/µL and platelets>=100000/µL. C1 extramedullary disease status is required. CRi is defined as CR except with ANC <1000/µL and/or platelets <100000/µL. C1 defined as complete disappearance of all measurable and non-measurable extramedullary disease with the exception of lesions with following must be true: For participants with>= 1 measurable lesion, all nodal masses>1.5cm in greatest transverse diameter (GTD) at baseline (last assessment before 1st dose of study treatment) must must have regressed to>=1.5cm in GTD and all nodal masses>=1cm & <=1.5cm in GTD at baseline have regressed to <1cm GTD or must have reduced by 75% in sum of products of greatest diameters. No new lesions. Spleen and other previously enlarged organs must have regressed in size and must not be palpable. | All participants who were randomized into the study with study drug assignment based on randomization. | Posted | Number | Percentage of Participants | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Adverse event (AE) = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. On-treatment period was defined as the period starting with the 1st dose of study treatment through 63 days after last dose or 1 day before start day of new anticancer therapy, whichever occurred first. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All VOD cases were reported as SAE. Grades of severity were defined by Common terminology criteria for adverse events (CTCAE) v3.0. Grade 3=severe adverse event; Grade 4=life-threatening consequences; urgent intervention indicated. Grade 5=death related to AE. Results were reported as of the data cutoff date on 21 Sep 2022. | All randomized participants who receive at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study treatment drug through 63 days after last dose (approximately 52 weeks) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (Treatment-related) | Adverse event (AE) = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Treatment emergent AEs (TEAEs) were defined as AEs that reported the period starting with the first dose of study treatment drug through 63 days after last dose or 1 day before start day of new anticancer therapy, whichever occurred first. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grades of severity were defined by CTCAE v3.0. Grade 3 = severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE. Causality of TEAEs were assessed by the Investigator. Results were reported as of the data cutoff date on 21 Sep 2022. | All randomized participants who receive at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study treatment drug through 63 days after last dose (approximately 52 weeks) |
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| Secondary | Number of Participants With Treatment-Emergent Serious Adverse Events (Post-HSCT) | A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All SAEs occurred after HSCT were reported in this OM. Results were reported as of the data cutoff date on 21 Sep 2022. | All randomized participants who receive at least 1 dose of study drug and were post HSCT. | Posted | Count of Participants | Participants | Starting from the first transplant after inotuzumab ozogamicin treatment and including the entire duration of subsequent follow up (approximately 52 weeks)) |
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| Secondary | Shift Summary of Hematology Laboratory Test Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline | Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Following Parameters were analyzed for laboratory assessment: Hematology (Activated partial thromboplastin time prolonged, Anemia, Hemoglobin increased, International normalization rate (INR) increased, Leukocytosis, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, White blood cell decreased). Grades of severity were defined by CTCAE v3.0. Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. Results were reported as of the data cutoff date on 21 Sep 2022. | All randomized participants who receive at least 1 dose of study drug and with at least 1 postbaseline assessment in each treatment group. 'Number analyzed' = Participants evaluable for this outcome measure for each specified row. | Posted | Count of Participants | Participants | From first dose of study treatment drug through 63 days after last dose (approximately 52 weeks) |
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| Secondary | Shift Summary of Chemistry Laboratory Test Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline | Baseline assessment was defined as the last assessment performed on or prior to the date of the first dose of study treatment. Following Parameters were analyzed for laboratory assessment: Chemistry (Alanine aminotransferase increased, Alkaline phosphatase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Chronic kidney disease, Creatinine increased, Gamma glutamyl transpeptidase (GGT) increased, Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypermagnesemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hypomagnesemia, Hyponatremia, Hypophosphatemia, Lipase increased and Serum amylase increased). Grades of severity were defined by CTCAE v3.0. Grade 2 = moderate adverse event; Grade 3= severe adverse event; Grade 4 = life-threatening consequences; urgent intervention indicated. Results were reported as of the data cutoff date on 21 Sep 2022. | All randomized participants who receive at least 1 dose of study drug and with at least 1 postbaseline assessment in each treatment group. 'Number analyzed' = Participants evaluable for this outcome measure for each specified row. | Posted | Count of Participants | Participants | From first dose of study treatment drug through 63 days after last dose (approximately 52 weeks) |
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| Secondary | Number of Participants Achieving a CR/CRi With Minimal Residual Disease (MRD) Negativity | MRD was assessed by flow cytometry for CD22 and other cell surface markers associated with B-cell ALL. In participants who achieved CR/CRi, MRD negativity was defined as defined as <1 abnormal cell/10^4 nucleated cells by flow cytometry per central laboratory analysis. | All participants who were randomized into the study and achieved CR/CRi. | Posted | Count of Participants | Participants | At screening, once at Day 16-28 of Cycles 1 and 2, or until CR/CRi and MRD negativity were achieved, then after every 1-2 cycles as clinically indicated, and at EOT visit (maximum of 2.5 years) |
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| Secondary | Duration of Remission (DoR) in Participants Achieving CR/CRi | DoR was defined as time from date of first response in responders (CR/CRi) to the date of disease progression (i.e., objective progression, relapse from CR/CRi, including post-study treatment follow-up disease assessments) or death due to any cause, whichever occurs first. DoR was estimated using Kaplan-Meier methods. Results were reported as of the data cutoff date on 21 Sep 2022. | Participants who were randomized into the study and with a remission (CR/CRi). | Posted | Median | 95% Confidence Interval | Months | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
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| Secondary | Progression-Free Survival | PFS was defined as time from date of randomization to the date of disease progression (i.e., objective progression, relapse from CR/CRi, including post-study treatment follow-up disease assessments), death due to any cause, or starting new induction therapy/post-therapy HSCT without achieving CR/CRi, whichever occured first. PFS was estimated using Kaplan-Meier methods. Results were reported as of the data cutoff date on 21 Sep 2022. | All participants who were randomized into the study with study drug assignment based on randomization. | Posted | Median | 95% Confidence Interval | Months | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
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| Secondary | Overall Survival | Overall survival was defined as the time from date of first dose of study treatment to death due to any cause. Participants without confirmation of death were censored at the date that the participant was last known to be alive. Results were reported as of the data cutoff date on 21 Sep 2022. | All patients who were randomized into the study with study drug assignment based on randomization. | Posted | Median | 95% Confidence Interval | Months | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
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| Secondary | Number of Participant Received HSCT Post Inotuzumab Ozogamicin Treatment | Participants who underwent HSCT after inotuzumab ozogamicin treatment. Results were reported as of the data cutoff date on 21 Sep 2022. | All participants who were randomized into the study with study drug assignment based on randomization. | Posted | Count of Participants | Participants | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
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| Secondary | The Cumulative Incidence Rate of Post-HSCT Relapse at Month 12 | Post-HSCT relapse is defined as the time from date of first HSCT after inotuzumab ozogamicin treatment to the date of first relapse post-HSCT. Cumulative incidence rates of an event at a particular timepoint were estimated with the CI calculated based on the cumulative incidence function using the method described by Kalbfleisch RL and Prentice JD. Results were reported as of the data cutoff date on 21 Sep 2022. | All participants who were randomized into the study with study drug assignment based on randomization and who were post HSCT. | Posted | Number | 95% Confidence Interval | Percentages of participants | From first dose of study treatment to Month 12 |
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| Secondary | Number of Participants With Post-HSCT Mortality | Post-HSCT Mortality was defined as the time from date of first HSCT after inotuzumab ozogamicin treatment to death due to any cause. Results were reported as of the data cutoff date on 21 Sep 2022. | All participants who were randomized into the study with study drug assignment based on randomization and who were post HSCT. | Posted | Count of Participants | Participants | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
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| Secondary | Number of Participants With Post HSCT Non-Relapse Mortality | Post HSCT non-relapse mortality was defined as time from date of first HSCT after inotuzumab ozogamicin treatment to death due to any cause without prior relapse. Results were reported as of the data cutoff date on 21 Sep 2022. | All participants who were randomized into the study with study drug assignment based on randomization and who underwent HSCT after inotuzumab ozogamicin treatment. | Posted | Count of Participants | Participants | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
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| Secondary | Number of Participants With Post HSCT Relapse-Related Mortality | Post HSCT Relapse-Related Mortality was defined as time from date of first HSCT after inotuzumab ozogamicin treatment to death due to any cause with prior relapse. Results were reported as of the data cutoff date on 21 Sep 2022. | All participants who were randomized into the study with study drug assignment based on randomization and who underwent HSCT after inotuzumab ozogamicin treatment. | Posted | Count of Participants | Participants | From first dose of study treatment of 6 cycles till follow-up up to 2 years, in total approximately 2.5 years |
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| Secondary | Mean Predose Concentrations (Ctrough) of Inotuzumab Ozogamicin | Ctrough was defined as the mean Predose concentration of study treatment. | All treated participants who received at least 1 dose of study drug and had at least one PK sample collected and analyzed. 'Number analyzed' = Participants evaluable for this outcome measure for each specified row. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose on Cycle 1 Day 1, 8 and 15, and on Day1 and 8 of Cycle 2, 3 and 4. |
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| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) | ADA incidence is defined as combined results of treatment-boosted and treatment-induced ADA-positive participants. The immunogenicity of inotuzumab ozogamicin was evaluated using a validated electrochemiluminescence (ECL)-based immunoassay. | Participants who received at least 1 dose of study drug and had at least 1 ADA sample collected and analyzed for immunogenicity. | Posted | Count of Participants | Participants | At Day 1 of every cycle prior to the beginning of inotuzumab ozogamicin infusion and at the EOT visit, up to approximately 52 weeks. |
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| Secondary | Number of Participants With Positive Neutralizing Antibody (NAb) | NAb incidence is defined as combined results of treatment-boosted and treatment-induced NAb-positive participants. The immunogenicity of inotuzumab ozogamicin was evaluated using a validated electrochemiluminescence (ECL)-based immunoassay. | Participants who received at least 1 dose of study drug and had at least 1 Nab sample collected and analyzed for immunogenicity. | Posted | Count of Participants | Participants | At Day 1 of every cycle prior to the beginning of inotuzumab ozogamicin infusion and at the EOT visit, up to approximately 52 weeks. |
|
From the first dose of study treatment drug through 63 days after last dose or 1 day before start day of new anti-cancer therapy, whichever occurs first (approximately 52 weeks).
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set. AEs were reported as of the data cutoff date on 21 Sep 2022.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle administrated in 3 divided doses (0.6 mg/m² on Day1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete response (CR)/complete remission with incomplete hematologic recovery (CRi) was achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Days 1, 8 and 15). The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. | 16 | 22 | 15 | 22 | 18 | 22 |
| EG001 | 1.2 mg/m²/Cycle (Dose Level 2 Randomized Phase) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle administrated in 3 divided doses (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After CR/CRi was achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Days 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. | 23 | 42 | 28 | 42 | 32 | 42 |
| EG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. | 39 | 64 | 43 | 64 | 50 | 64 |
| EG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized Phase) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle administrated in 3 divided doses (0.8 mg/m² on Day 1, 0.5 mg/m² on Days 8 and 15) intravenously. After CR/CRi was achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Days 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. | 25 | 38 | 21 | 38 | 29 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia megaloblastic | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Graft versus host disease in liver | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hepatosplenic candidiasis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Klebsiella test positive | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neoplasm recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Non-systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Focal dyscognitive seizures | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Sinus polyp | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2022 | Sep 18, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015452 | Precursor B-Cell Lymphoblastic Leukemia-Lymphoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000080045 | Inotuzumab Ozogamicin |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG = 1 |
|
| ECOG = 2 |
|
| OG001 | 1.2 mg/m²/Cycle (Dose Level 2 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG001 | 1.2 mg/m²/Cycle (Dose Level 2 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG001 | 1.2 mg/m²/Cycle (Dose Level 2 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG001 | 1.2 mg/m²/Cycle (Dose Level 2 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG001 | 1.2 mg/m²/Cycle (Dose Level 2 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 |
| 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) |
Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 |
| 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) |
Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
|
|
| OG002 | 1.2 mg/m²/Cycle (Dose Level 2 Run-in + Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.2 mg/m²/cycle (0.6 mg/m² on Day 1, 0.3 mg/m² on Days 8 and 15) intravenously. After complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) is achieved, the dose was reduced to 0.9 mg/m²/cycle (0.3 mg/m² on Day 1, 8 and 15). The maximum treatment duration was approximately 52 weeks. |
| OG003 | 1.8 mg/m²/Cycle (Dose Level 1 Randomized) | Participants received a starting dose of inotuzumab ozogamicin 1.8 mg/m²/cycle (0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8 and 15) intravenously. After CR/CRi is achieved, the dose was reduced to 1.5 mg/m²/cycle (0.5 mg/m² on Day 1, 8 and 15) for 2-3 cycles. The cycle length was 21-28 days. The maximum treatment duration was approximately 52 weeks. |
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