A Phase 3 interventional study of inotuzumab ozogamicin and FLAG (fludarabine, cytarabine and G-CSF) in Acute Lymphoblastic Leukemia, sponsored by Pfizer. Completed at 198 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 326 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Drug: inotuzumab ozogamicin
Drug: FLAG (fludarabine, cytarabine and G-CSF) · Drug: HIDAC (high dose cytarabine) · Drug: cytarabine and mitoxantrone
Dose: inotuzumab ozogamicin 0.8-0.5 mg/m\^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
Dose: cytarabine 2.0 g/m\^2/day IV days 1-6 fludarabine30 mg/m\^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4
cytarabine 3 g/m\^2 IV every 12 hours for up to 12 times
mitoxantrone 12 mg/m\^2 IV days 1-3 cytarabine 200 mg/m\^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4
Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)
CR was the disappearance of leukemia indicated by less than (\<) 5 percent (%) marrow blasts \& absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) \& platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable \& non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (\>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm \& ≤1.5 cm in GTD at baseline must have regressed to \<1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen \& other previously enlarged organs must have regressed in size \& must not be palpable) was required. CRi was defined as CR except ANC \<1000/μL \&/or platelets \<100,000/μL.
Time frame: Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose
Overall Survival (OS)
OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.
Time frame: Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.
Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)
DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease \[objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status\] or starting new induction therapy or post-therapy stem cell transplant \[SCT\] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up.
Time frame: Up to 2 years from randomization
Progression-Free Survival (PFS)
PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (\>28 weeks if there was post-baseline disease assessment, or \>12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method.
Time frame: Up to 2 years from randomization
Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy.
Time frame: Up to 19 weeks from last dose
Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)
MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was \<1 × 10\^-4 blasts/nucleated cells.
Time frame: Up to approximately 4 weeks (EoT) from last dose of study drug
Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)
Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening.
Time frame: Up to approximately 4 weeks (EoT) from last dose of study drug
Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing
Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations).
Time frame: Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score
This questionnaire comprised 30 questions within which are 9 multi-item scales \& 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional \& social, 3 symptom scales; fatigue, pain, \& nausea \& vomiting, \& a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, \& dyspnea) \& a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged \& transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms.
Time frame: Day 1 of each cycle prior to dosing and EoT
Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score
The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
Time frame: Day 1 of each cycle prior to dosing and EoT
Change From Baseline in EQ-5D VAS
The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Time frame: Day 1 of each cycle prior to dosing and EoT
Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT
VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level \>34 micromoles per liter (μmol/L) (\>2.0 milligrams per deciliter \[mg/dL\]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain \>2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.
Time frame: Up to 2 years from randomization
| Milestone | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Started | 164 | 143 |
| Completed | 30 | 10 |
| Not completed | 134 | 133 |
| Withdrew: Other | 1 | 0 |
| Withdrew: Subject refused further follow-up | 1 | 6 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Death | 131 | 126 |
CR was the disappearance of leukemia indicated by less than (\<) 5 percent (%) marrow blasts \& absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) \& platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable \& non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (\>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm \& ≤1.5 cm in GTD at baseline must have regressed to \<1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen \& other previously enlarged organs must have regressed in size \& must not be palpable) was required. CRi was defined as CR except ANC \<1000/μL \&/or platelets \<100,000/μL.
| Percentage of Participants | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) | 80.7 (72.1 to 87.7) | 29.4 (21.0 to 38.8) |
OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.
| Months | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Overall Survival (OS) | 7.7 (6.0 to 9.2) | 6.2 (4.7 to 8.3) |
DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease \[objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status\] or starting new induction therapy or post-therapy stem cell transplant \[SCT\] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up.
| Months | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) | 5.4 (4.3 to 8.0) | 3.5 (2.2 to 6.6) |
PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (\>28 weeks if there was post-baseline disease assessment, or \>12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method.
| Months | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Progression-Free Survival (PFS) | 5.0 (3.9 to 5.8) | 1.7 (1.4 to 2.1) |
HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy.
| Percentage of Participants | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) | 42.7 (35.0 to 50.6) | 11.1 (6.7 to 17.0) |
MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was \<1 × 10\^-4 blasts/nucleated cells.
| Percentage of Participants | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment) | 78.4 (68.4 to 86.5) | 28.1 (13.7 to 46.7) |
Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening.
| Percentage of Participants | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment) | 3.7 (0.5 to 12.7) | 18.2 (5.2 to 40.3) |
Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations).
| ng/mL | Inotuzumab Ozogamicin |
|---|---|
| Cmax (Cycle 1 Day 1, 1 hour post-dose) (n=128) | 211 ± 232 |
| Ctrough (Cycle 4 Day 1, pre-dose) (n=46) | 57.9 ± 29.8 |
| Cmax (Cycle 4 Day 1, 1 hour post-dose) (n=37) | 308 ± 362 |
This questionnaire comprised 30 questions within which are 9 multi-item scales \& 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional \& social, 3 symptom scales; fatigue, pain, \& nausea \& vomiting, \& a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, \& dyspnea) \& a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged \& transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms.
| Score on a scale | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Physical Functioning C2D1 | 0.48 ± 1.53 | 0.32 ± 3.55 |
| Physical Functioning C3D1 | 3.15 ± 1.97 | -13.33 ± 7.70 |
| Physical Functioning C4D1 | 5.33 ± 2.84 | 0.00 ± NA |
| Physical Functioning C5D1 | 11.52 ± 3.51 | NA ± NA |
| Physical Functioning C6D1 | 7.22 ± 5.94 | NA ± NA |
| Physical Functioning EoT | -3.38 ± 2.03 | -8.17 ± 2.67 |
| Role Functioning C2D1 | 5.45 ± 2.79 | -1.59 ± 8.21 |
| Role Functioning C3D1 | 11.81 ± 3.19 | -11.11 ± 5.56 |
| Role Functioning C4D1 | 16.67 ± 5.47 | 0.00 ± NA |
| Role Functioning C5D1 | 12.88 ± 6.10 | NA ± NA |
| Role Functioning C6D1 | 16.67 ± 11.42 | NA ± NA |
| Role Functioning EoT | 1.32 ± 3.59 | -12.37 ± 4.09 |
| Emotional Functioning C2D1 | 5.21 ± 1.76 | 4.76 ± 6.77 |
| Emotional Functioning C3D1 | 7.41 ± 1.85 | -19.44 ± 10.02 |
| Emotional Functioning C4D1 | 5.69 ± 1.63 | 0.00 ± NA |
| Emotional Functioning C5D1 | 6.82 ± 2.83 | NA ± NA |
| Emotional Functioning C6D1 | 2.78 ± 4.27 | NA ± NA |
| Emotional Functioning EoT | -0.91 ± 1.80 | 4.35 ± 2.96 |
| Cognitive Functioning C2D1 | 4.05 ± 1.47 | 0.00 ± 3.98 |
| Cognitive Functioning C3D1 | 5.79 ± 2.11 | -5.56 ± 14.70 |
| Cognitive Functioning C4D1 | 4.58 ± 2.86 | 16.67 ± NA |
| Cognitive Functioning C5D1 | 0.76 ± 4.17 | NA ± NA |
| Cognitive Functioning C6D1 | -8.33 ± 2.51 | NA ± NA |
| Cognitive Functioning EoT | 0.83 ± 1.82 | 0.54 ± 2.89 |
| Social Functioning C2D1 | 4.20 ± 2.46 | -2.38 ± 7.21 |
| Social Functioning C3D1 | 5.56 ± 3.25 | -27.78 ± 20.03 |
| Social Functioning C4D1 | 10.42 ± 4.95 | 0.00 ± NA |
| Social Functioning C5D1 | 12.88 ± 6.00 | NA ± NA |
| Social Functioning C6D1 | 16.67 ± 5.03 | NA ± NA |
| Social Functioning EoT | 1.82 ± 2.84 | -2.15 ± 4.78 |
| Global Health Status C2D1 | 3.98 ± 2.03 | 0.40 ± 4.62 |
| Global Health Status C3D1 | 9.38 ± 3.15 | -16.67 ± 12.73 |
| Global Health Status C4D1 | 11.25 ± 3.69 | 8.33 ± NA |
| Global Health Status C5D1 | 8.71 ± 6.68 | NA ± NA |
| Global Health Status C6D1 | 0.69 ± 6.76 | NA ± NA |
| Global Health Status EoT | 0.00 ± 2.83 | -0.40 ± 3.28 |
| Dyspnoea C2D1 | -5.41 ± 2.72 | -7.94 ± 6.47 |
| Dyspnoea C3D1 | -7.41 ± 3.24 | 11.11 ± 11.11 |
| Dyspnoea C4D1 | -12.50 ± 4.25 | 0.00 ± NA |
| Dyspnoea C5D1 | -3.03 ± 6.55 | NA ± NA |
| Dyspnoea C6D1 | -2.78 ± 6.43 | NA ± NA |
| Dyspnoea EoT | -2.31 ± 3.09 | 0.54 ± 3.95 |
| Insomnia C2D1 | -2.40 ± 3.01 | 1.59 ± 5.85 |
| Insomnia C3D1 | -9.26 ± 3.38 | 0.00 ± 19.25 |
| Insomnia C4D1 | -7.50 ± 3.27 | 0.00 ± NA |
| Insomnia C5D1 | -4.55 ± 4.55 | NA ± NA |
| Insomnia C6D1 | -11.11 ± 9.48 | NA ± NA |
| Insomnia EoT | -2.31 ± 3.09 | 0.00 ± 3.91 |
| Appetite Loss C2D1 | -4.20 ± 2.83 | 3.17 ± 7.24 |
| Appetite Loss C3D1 | -8.33 ± 4.31 | 0.00 ± 0.00 |
| Appetite Loss C4D1 | -11.67 ± 5.54 | 0.00 ± NA |
| Appetite Loss C5D1 | -6.06 ± 7.80 | NA ± NA |
| Appetite Loss C6D1 | 2.78 ± 9.59 | NA ± NA |
| Appetite Loss EoT | -1.32 ± 3.54 | 11.83 ± 4.41 |
| Constipation C2D1 | -1.21 ± 2.47 | 0.00 ± 5.14 |
| Constipation C3D1 | 0.47 ± 3.44 | 0.00 ± 0.00 |
| Constipation C4D1 | -2.50 ± 3.66 | 0.00 ± NA |
| Constipation C5D1 | 0.00 ± 5.37 | NA ± NA |
| Constipation C6D1 | 5.56 ± 5.56 | NA ± NA |
| Constipation EoT | 2.64 ± 2.60 | -0.54 ± 2.71 |
| Diarrhoea C2D1 | -3.30 ± 2.17 | -1.59 ± 4.87 |
| Diarrhoea C3D1 | -5.09 ± 2.61 | -11.11 ± 11.11 |
| Diarrhoea C4D1 | -0.83 ± 3.27 | 0.00 ± NA |
| Diarrhoea C5D1 | -9.52 ± 4.68 | NA ± NA |
| Diarrhoea C6D1 | -2.78 ± 4.95 | NA ± NA |
| Diarrhoea EoT | 2.31 ± 1.89 | 3.76 ± 3.35 |
| Financial Difficulties C2D1 | -1.80 ± 1.99 | 0.00 ± 8.72 |
| Financial Difficulties C3D1 | 0.47 ± 3.24 | 0.00 ± 0.00 |
| Financial Difficulties C4D1 | -1.67 ± 3.37 | 0.00 ± NA |
| Financial Difficulties C5D1 | -3.03 ± 3.74 | NA ± NA |
| Financial Difficulties C6D1 | -5.56 ± 3.75 | NA ± NA |
| Financial Difficulties EoT | 0.33 ± 3.09 | 2.19 ± 2.80 |
| Fatigue C2D1 | -4.10 ± 2.40 | 5.82 ± 6.88 |
| Fatigue C3D1 | -8.33 ± 3.02 | 22.22 ± 6.42 |
| Fatigue C4D1 | -9.17 ± 4.64 | -11.11 ± NA |
| Fatigue C5D1 | -7.32 ± 5.61 | NA ± NA |
| Fatigue C6D1 | 0.00 ± 6.42 | NA ± NA |
| Fatigue Eot | -0.33 ± 2.66 | 5.73 ± 3.27 |
| Nausea and Vomiting C2D1 | 0.15 ± 2.16 | -0.79 ± 2.69 |
| Nausea and Vomiting C3D1 | -4.63 ± 2.80 | 0.00 ± 0.00 |
| Nausea and Vomiting C4D1 | -3.33 ± 3.17 | -16.67 ± NA |
| Nausea and Vomiting C5D1 | 2.27 ± 2.96 | NA ± NA |
| Nausea and Vomiting C6D1 | 0.00 ± 2.90 | NA ± NA |
| Nausea and Vomiting EoT | -0.17 ± 2.33 | 3.49 ± 2.43 |
| Pain C2D1 | -8.86 ± 2.71 | -7.14 ± 7.68 |
| Pain C3D1 | -8.56 ± 3.73 | -5.56 ± 14.70 |
| Pain C4D1 | -4.17 ± 3.81 | -33.33 ± NA |
| Pain C5D1 | 0.76 ± 7.48 | NA ± NA |
| Pain C6D1 | -2.78 ± 9.59 | NA ± NA |
| Pain EoT | -1.98 ± 2.88 | -7.26 ± 3.75 |
The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).
| Score on a scale | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Cycle 2, Day 1 | 0.00 ± 0.02 | 0.02 ± 0.03 |
| Cycle 3, Day 1 | 0.01 ± 0.02 | -0.08 ± 0.08 |
| Cycle 4, Day 1 | 0.04 ± 0.03 | 0.00 ± NA |
| Cycle 5, Day 1 | 0.04 ± 0.04 | NA ± NA |
| Cycle 6, Day 1 | 0.03 ± 0.04 | NA ± NA |
| EoT | -0.01 ± 0.02 | -0.04 ± 0.02 |
The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
| Score on a scale | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Cycle 2, Day 1 | 5.81 ± 2.14 | 5.90 ± 4.21 |
| Cycle 3, Day 1 | 8.13 ± 2.53 | 19.67 ± 17.80 |
| Cycle 4, Day 1 | 7.13 ± 3.37 | 44.00 ± NA |
| Cycle 5, Day 1 | 7.62 ± 4.43 | NA ± NA |
| Cycle 6, Day 1 | 15.09 ± 9.14 | NA ± NA |
| EoT | 4.62 ± 2.38 | -0.52 ± 2.88 |
VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level \>34 micromoles per liter (μmol/L) (\>2.0 milligrams per deciliter \[mg/dL\]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain \>2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.
| Percentage of Participants | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT | 22.8 | 8.6 |
Collected over SAEs and non-serious AEs are summarized from Cycle 1 Day 1 up to 42 days after last dose, or any time after Cycle 1 Day1 (treatment-related).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inotuzumab Ozogamicin | — | 85/164 (51.8%) | 159/164 (97%) |
| Defined Investigator's Choice of Chemotherapy | — | 72/143 (50.3%) | 143/143 (100%) |
| Event | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 19/164 | 27/143 |
| Venoocclusive liver diseaseHepatobiliary disorders | 23/164 | 3/143 |
| SepsisInfections and infestations | 4/164 | 10/143 |
| PneumoniaInfections and infestations | 10/164 | 0/143 |
| Disease progressionGeneral disorders | 8/164 | 5/143 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/164 | 6/143 |
| PyrexiaGeneral disorders | 5/164 | 3/143 |
| Neutropenic sepsisInfections and infestations | 3/164 | 4/143 |
| HyperbilirubinaemiaHepatobiliary disorders | 0/164 | 3/143 |
| Pneumonia fungalInfections and infestations | 0/164 | 3/143 |
| Event | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy |
|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 80/164 | 86/143 |
| AnaemiaBlood and lymphatic system disorders | 54/164 | 79/143 |
| NeutropeniaBlood and lymphatic system disorders | 79/164 | 66/143 |
| NauseaGastrointestinal disorders | 52/164 | 68/143 |
| PyrexiaGeneral disorders | 49/164 | 57/143 |
| DiarrhoeaGastrointestinal disorders | 30/164 | 55/143 |
| LeukopeniaBlood and lymphatic system disorders | 47/164 | 54/143 |
| Febrile neutropeniaBlood and lymphatic system disorders | 27/164 | 52/143 |
| HeadacheNervous system disorders | 45/164 | 38/143 |
| LymphopeniaBlood and lymphatic system disorders | 31/164 | 36/143 |
| Age, Continuous(Years) | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy | Total |
|---|---|---|---|
| Mean | 45.9 ± 17.07 | 45.6 ± 16.32 | 45.7 ± 16.70 |
| Sex: Female, Male(Participants) | Inotuzumab Ozogamicin | Defined Investigator's Choice of Chemotherapy | Total |
|---|---|---|---|
| Female | 73 | 51 | 124 |
| Male | 91 | 92 | 183 |
Showing the first 100 of 198 sites across 20 countries.
Plan to share: Yes — 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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