Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
ConditionAcute Lymphocytic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age16-75
SponsorLeland Metheny
About this trial
This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects.
The Phase II portion of this study is to see what side effects are seen with medication after transplant.
Inotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed/refractory acute lymphocytic leukemia (ALL).
Inotuzumab ozogamicin is considered experimental in this study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia
Patients who are between T+40 and T+100 after allogeneic transplantation. Patients must receive their first dose of inotuzumab at or before T+100.
Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation
Disqualifiers
Patients with clinical evidence of disease progression prior to enrollment
Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)
Creatinine clearance < 30ml/min
Bilirubin > 2X institutional upper limit of normal
Trial design
Design model
Single group
Treatments tested in this trial
Inotuzumab Ozogamicin
DrugInotuzumab ozogamicin, IV, 28 day cycles Phase 1 dosages: Dose Level -2 (0.1 mg/m\^2) Dose Level -1 (0.2 mg/m\^2) Dose Level 0 (0.3 mg/m\^2) Dose Level 1 (0.4 mg/m\^2) Dose Level 2 (0.5 mg/m\^2) Dose Level 3 (0.6 mg/m\^2)
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Inotuzumab OzogamicinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase I MTD
Defined post hematopoietic stem cell transplantation MTD
Time frame
Up to 112 days (16 weeks)2
Phase I DLTs
Frequency of DLTs during the first two cycles in ALL-participants
Time frame
Up to 112 days (16 weeks)3
Phase II Median DFS
Efficacy as measured by phase II DFS at one year, estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of first dose to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)". Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10 In Phase II, the null hypothesis of H0: DFS at 1-year ≤ 55% versus the alternative hypothesis of Ha: DFS at 1-year ≥ 75% using 1-sided alpha of 10% will be tested
Time frame
At 3 months after initial treatment4
Phase II Median DFS
Efficacy as measured by phase II DFS at one year, estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of first dose to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)". Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10 In Phase II, the null hypothesis of H0: DFS at 1-year ≤ 55% versus the alternative hypothesis of Ha: DFS at 1-year ≥ 75% using 1-sided alpha of 10% will be tested
Time frame
At 6 months after initial treatmentSecondary outcomes
1
Phase I Median DFS
Efficacy as measured by phase I DFS at one year. Estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of first dose to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)" Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10
Time frame
At 3 months after initial treatment2
Phase I Median DFS
Efficacy as measured by phase I DFS at one year. Estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of first dose to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)" Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10
Time frame
At 6 months after initial treatment3
Phase I Median DFS
Efficacy as measured by phase I DFS at one year. Estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of first dose to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)" Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10
Time frame
At 9 months after initial treatment4
Phase I Median DFS
Efficacy as measured by phase I DFS at one year. Estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of first dose to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)" Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10
Time frame
At 1 year after initial treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Leland Metheny
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov