Trial · NCT01564784
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
NCT01564784, Phase 3, Completed, Pfizer; results first posted 2018-01-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia. Trials, record NCT01564784. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01564784
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
- NCT number
- NCT01564784
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 326 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- inotuzumab ozogamicin, FLAG (fludarabine, cytarabine and G-CSF), HIDAC (high dose cytarabine), cytarabine and mitoxantrone
- First posted
- 2012-03-28
- Last updated
- 2019-01-09
- Other registries' IDs
- eudract:2011-005491-41
- Results first posted
- 2018-01-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) | 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 | 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. |
| Primary | Overall Survival (OS) | Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first. | 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. |
| Secondary | Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) | Up to 2 years from randomization | 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. |
| Secondary | Progression-Free Survival (PFS) | Up to 2 years from randomization | 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. |
| Secondary | Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) | Up to 19 weeks from last dose | HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy. |
| Secondary | Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment) | Up to approximately 4 weeks (EoT) from last dose of study drug | 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. |
| Secondary | Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment) | Up to approximately 4 weeks (EoT) from last dose of study drug | 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. |
| Secondary | Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing | Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4 | 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). |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score | Day 1 of each cycle prior to dosing and EoT | 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. |
| Secondary | Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score | Day 1 of each cycle prior to dosing and EoT | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) | 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 | ITT218 population - included the ITT population (all participants randomized) for the initial 218 participants. | Percentage of Participants | NUMBER |
| PRIMARY | Overall Survival (OS) | Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first. | ITT population - included all participants randomized. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Months | MEDIAN |
| SECONDARY | Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) | Up to 2 years from randomization | Participants in the ITT218 population who achieved CR/CRi | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Up to 2 years from randomization | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) | Up to 19 weeks from last dose | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment) | Up to approximately 4 weeks (EoT) from last dose of study drug | Participants in the ITT218 population achieving CR/CRi (per EAC Assessment) | Percentage of Participants | NUMBER |
| SECONDARY | Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment) | Up to approximately 4 weeks (EoT) from last dose of study drug | Participants in the ITT218 population who had abnormal cytogenetics at baseline and who achieved CR/CRi | Percentage of Participants | NUMBER |
| SECONDARY | Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing | Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4 | Pharmacokinetic (PK) evaluable population - included all participants with available PK data. | ng/mL | MEAN |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score | Day 1 of each cycle prior to dosing and EoT | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score | Day 1 of each cycle prior to dosing and EoT | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group223
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) | Inotuzumab Ozogamicin | 80.7 | 95% Confidence Interval 72.1 to 87.7 | Percentage of Participants | |
| Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) | Defined Investigator's Choice of Chemotherapy | 29.4 | 95% Confidence Interval 21.0 to 38.8 | Percentage of Participants | |
| Overall Survival (OS) | Inotuzumab Ozogamicin | 7.7 | 95% Confidence Interval 6.0 to 9.2 | Months | |
| Overall Survival (OS) | Defined Investigator's Choice of Chemotherapy | 6.2 | 95% Confidence Interval 4.7 to 8.3 | Months | |
| Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) | Inotuzumab Ozogamicin | 5.4 | 95% Confidence Interval 4.3 to 8.0 | Months | |
| Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) | Defined Investigator's Choice of Chemotherapy | 3.5 | 95% Confidence Interval 2.2 to 6.6 | Months | |
| Progression-Free Survival (PFS) | Inotuzumab Ozogamicin | 5.0 | 95% Confidence Interval 3.9 to 5.8 | Months | |
| Progression-Free Survival (PFS) | Defined Investigator's Choice of Chemotherapy | 1.7 | 95% Confidence Interval 1.4 to 2.1 | Months | |
| Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) | Inotuzumab Ozogamicin | 42.7 | 95% Confidence Interval 35.0 to 50.6 | Percentage of Participants | |
| Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) | Defined Investigator's Choice of Chemotherapy | 11.1 | 95% Confidence Interval 6.7 to 17.0 | Percentage of Participants |
1 to 10 of 223Source ClinicalTrials.gov
See all 223 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inotuzumab Ozogamicin | 164 | |
| Overall Study | STARTED | Defined Investigator's Choice of Chemotherapy | 143 | |
| Overall Study | COMPLETED | Inotuzumab Ozogamicin | 30 | |
| Overall Study | COMPLETED | Defined Investigator's Choice of Chemotherapy | 10 | |
| Overall Study | NOT COMPLETED | Inotuzumab Ozogamicin | 134 | |
| Overall Study | NOT COMPLETED | Defined Investigator's Choice of Chemotherapy | 133 |
Source ClinicalTrials.gov
Adverse events384
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 54 | 164 | |
| other | Anaemia | Blood and lymphatic system disorders | Defined Investigator's Choice of Chemotherapy | 79 | 143 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 27 | 164 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Defined Investigator's Choice of Chemotherapy | 52 | 143 | |
| other | Leukopenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 47 | 164 | |
| other | Leukopenia | Blood and lymphatic system disorders | Defined Investigator's Choice of Chemotherapy | 54 | 143 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 31 | 164 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Defined Investigator's Choice of Chemotherapy | 36 | 143 | |
| other | Neutropenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin | 79 | 164 | |
| other | Neutropenia | Blood and lymphatic system disorders | Defined Investigator's Choice of Chemotherapy | 66 | 143 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inotuzumab Ozogamicin | ||
| Total, all-cause mortality | Defined Investigator's Choice of Chemotherapy | ||
| Total, other adverse events | Inotuzumab Ozogamicin | 159 | 164 |
| Total, other adverse events | Defined Investigator's Choice of Chemotherapy | 143 | 143 |
| Total, serious adverse events | Inotuzumab Ozogamicin | 85 | 164 |
| Total, serious adverse events | Defined Investigator's Choice of Chemotherapy | 72 | 143 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Inotuzumab Ozogamicin vs Defined Investigator's Choice of Chemotherapy: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01564784
GET https://conductscience.org/api/trials/v1/NCT01564784/results?page=2