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Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104491
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Leland Metheny, Case Comprehensive Cancer Center

Brief Summary:

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) and Non-Hodgkin's Lymphoma (NHL).

Inotuzumab ozogamicin is considered experimental in this study.


Condition or disease Intervention/treatment Phase
Acute Lymphocytic Leukemia Non-Hodgkin's Lymphoma Drug: Inotuzumab Ozogamicin Phase 1 Phase 2

Detailed Description:

Study Design This is a Phase I/II study of inotuzumab ozogamicin for the treatment of patients who underwent allogeneic transplantation for ALL or who underwent autologous transplant for NHL and have a high risk of relapse. For ALL and NHL, respectively, the Phase I portion of this study will be a 3+3 dose escalation trial, followed by a phase 2 cohort at the recommended Phase 2 dose (RP2D). Participants will receive study treatment up to 12 cycles until relapse of disease, unacceptable toxicity, or death, whichever occurs first

Phase I: Inotuzumab Ozogamicin Dosing Escalation Subjects will be assessed for safety and tolerability (including adverse events, serious adverse events, and clinical/laboratory assessments) using a continuous monitoring approach.

Phase II: Inotuzumab Ozogamicin Subjects will be assessed for safety and tolerability (including adverse events, serious adverse events, and clinical/laboratory assessments) using a continuous monitoring approach. In order to be included in the safety profile endpoint review, subjects must have received at least of 1 cycle of treatment.

Primary Objective

ALL Phase I: To define a post hematopoietic stem cell transplantation maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of inotuzumab ozogamicin in ALL.

NHL Phase I: To define a post hematopoietic stem cell transplantation MTD and RP2D of inotuzumab ozogamicin in NHL.

ALL Phase II: To assess the efficacy of inotuzumab ozogamicin as measured by diseasefree survival (DFS) at one year in ALL.

NHL Phase II: To assess the efficacy of inotuzumab ozogamicin as measured by DFS at one year in NHL.

Secondary Objective(s)

Phase 1 (for each cohort):

  • To evaluate disease-free survival (DFS), nonrelapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year.
  • To determine safety profile of inotuzumab ozogamicin after transplant including the incidence of myeloid toxicity and secondary graft failure and the rate of veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS).
  • To determine if inotuzumab ozogamicin at these doses is effective at eradicating minimal residual disease in this cohort of participants (ALL participants).
  • To evaluate the pharmacokinetics of inotuzumab ozogamicin post autologous transplant (NHL participants).

Phase 2 (for each cohort):

  • To assess additional evidence of efficacy and safety as measured by non-relapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year.
  • To determine if inotuzumab ozogamicin at these doses is effective at eradicating MRD in this cohort of participants (ALL participants).
  • To confirm the safety profile of inotuzumab ozogamicin therapy after transplant including myeloid toxicity, secondary graft failure, and the rate of VOD/SOS.
  • To evaluate the pharmacokinetics of inotuzumab ozogamicin post allogeneic and autologous transplant

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inotuzumab Ozogamicin Post-Transplant for Acute Lymphocytic Leukemia
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: Inotuzumab Ozogamicin

Phase I:

A maximum of 12 cycles will be allowed and doses will be adjusted in 0.1mg/m2 increments using a dose escalation scale depending on tolerability. Total range of dose levels for ALL participants is 0.1-0.6mg/m^2 and for NHL participants 0.2-0.8mg/m^2

Dosing in the NHL cohort will start at Dose Level 0 (0.3mg/m^2) or one dose level below the ALL cohort maximum tolerated dose (MTD), whichever is higher.

Phase II:

ALL and NHL participants: Will be enrolled until all Phase I ALL/NHL participants (respectively) have been followed and assessed for toxicity for at least 4 weeks after the fourth treatment dose of inotuzumab ozogamicin or 4 weeks after the participant goes off treatment, whichever comes first. Doses to be administered will be determined in the phase I portion of the study. Repeat cycles every 28 days for up to 12 cycles

Drug: Inotuzumab Ozogamicin

Inotuzumab ozogamicin, IV, 28 day cycles

ALL 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)

NHL Phase 1 dosages:

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)

Dose Level 4 (0.7 mg/m^2)

Dose Level 5 (0.8 mg/m^2)





Primary Outcome Measures :
  1. Phase I MTD [ Time Frame: Up to 112 days (16 weeks) ]
    Defined post hematopoietic stem cell transplantation MTD

  2. Phase I DLTs [ Time Frame: Up to 112 days (16 weeks) ]
    Frequency of DLTs during the first two cycles in ALL-participants and NHL-participants, reported separately

  3. Phase II Median DFS [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]

    Efficacy as measured by phase II DFS at one year in each cohort, 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 ALL Phase II cohort, 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

    In NHL Phase II cohort, the null hypothesis of H0: DFS at 1-year ≤ 55% versus the alternative hypothesis of Ha: DFS at 1-year ≥ 73% using 1-sided alpha of 10% will be tested



Secondary Outcome Measures :
  1. Phase I Median DFS [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]

    Efficacy as measured by phase I DFS at one year in each cohort. 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


  2. Phase I NRM [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]

    Phase I NRM in each cohort, defined as time from date of first dose to death due to any cause without prior relapse. Criteria used: For ALL, evidence of disease in the blood or bone marrow (flow cytometry or PCR); for lymphoma typically physical exam findings or CT scans

    Reported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI


  3. Phase I Relapse [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]

    Phase I relapse rate, defined as in each cohort, defined as time from date of first dose to the date of first relapse.

    Reported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI


  4. Phase I Relapse-related mortality [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]

    Phase I Relapse-related mortality in each cohort, defined time from date of first dose to death due to any cause with prior relapse

    Reported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI


  5. Phase I Median OS [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]

    Phase I OS, defined from time from date of first dose to death due to any cause, estimated using Kaplan-Meier, reported as median and 95% CI

    Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10


  6. Phase I pharmacokinetic (PK) parameters - Cmax (NHL cohort only) [ Time Frame: At Cycle 1 Day 1 (C1D1) (0 hour, 1 hour, 4 hours), Cycle 1 Day 7 (C1D7), Cycle 2 Day 1 (C2 D1) (0 hour, 1 hour), Cycle 4 Day 1 (C4D1) (0 hour, 1 hour) ]

    Phase I PK parameters (NHL cohort only)

    Cmax is maximum concentration. Descriptive statistics (n, mean, SD, %CV, median, minimum, maximum, geometric mean, its associated geometric %CV) of inotuzumab ozogamicin serum concentrations will be presented in tabular form by cycle, day, nominal time and cohort for the PK concentration analysis population.


  7. Phase I pharmacokinetic (PK) parameters - Ctrough (NHL cohort only) [ Time Frame: at C1D1 (0 hour, 1 hour, 4 hours), C1D7, C2 D1 (0 hour, 1 hour), C4D1 (0 hour, 1 hour) ]

    Phase I PK parameters (NHL cohort only)

    Ctrough is lowest concertration of Inotuzumab in the blood.Descriptive statistics (n, mean, SD, %CV, median, minimum, maximum, geometric mean, its associated geometric %CV) of inotuzumab ozogamicin serum concentrations will be presented in tabular form by cycle, day, nominal time and cohort for the PK concentration analysis population.


  8. Phase I Incidence of myeloid toxicity [ Time Frame: At 1 year ]
    Number of patients who develop myeloid toxicity while on study, defined as grade of anemia, neutropenia and thrombocytopenia CTCAE 4

  9. Phase I Incidence of secondary graft failure [ Time Frame: At 1 year ]

    Number of patients who develop secondary graft failure while on study, defined as:

    Either cytopenias after initial engraftment (ANC <500/µL), with (a) donor chimerism of less than 5% or (b) falling donor chimerism with intervention such as second transplant or donor lymphocyte infusion (DLI) or (c) patient death due to cytopenias, and fall in donor chimerism, even if chimerism was >5%. Exclusion criteria for diagnosis of GF were (a) disease relapse (b) graft versus host disease or (c) other causes of cytopenias such as, viral infections, or drug induced


  10. Phase I incidence of veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) [ Time Frame: At 1 year ]

    Safety profile of intervention as measured by incidence of VOD/SOS disease in the phase I portion of the study, defined as the occurrence of 2 of the following 3 clinical criteria:

    • Total serum bilirubin level >34 μmol/L (>2.0 mg/dL).
    • An increase in liver size from baseline or development of right upper quadrant pain of liver origin.
    • Sudden weight gain >2.5% during any 72-hour period after infusion of investigational product because of fluid accumulation or development of ascites.

  11. Phase I rate of VOD/SOS - number of participants affected [ Time Frame: At 1 year ]

    Safety profile of intervention as measured by number of participants affected by VOD/SOS disease in the phase I portion of the study, defined as the occurrence of 2 of the following 3 clinical criteria:

    • Total serum bilirubin level >34 μmol/L (>2.0 mg/dL).
    • An increase in liver size from baseline or development of right upper quadrant pain of liver origin.
    • Sudden weight gain >2.5% during any 72-hour period after infusion of investigational product because of fluid accumulation or development of ascites.

  12. Phase I - Percent of participants with grade 3 + AE/SAEs [ Time Frame: At 1 year ]
    Phase I safety profile of intervention as measured by percent of participants with grade 3 + AE/SAEs

  13. Phase II Non-relapse mortality (NRM) [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]

    Phase II Non-relapse mortality (NRM) in each cohort, defined as time from date of first dose to death due to any cause without prior relapse.

    Reported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI


  14. Phase II Relapse [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]

    Phase II relapse rate, defined as in each cohort, defined as time from date of first dose to the date of first relapse.

    Reported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI


  15. Phase II Relapse-related mortality [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]

    Phase II Relapse-related mortality in each cohort, defined time from date of first dose to death due to any cause with prior relapse

    Reported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI


  16. Phase II Median OS [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]

    Phase II OS in each cohort, defined from time from date of first dose to death due to any cause, estimated using Kaplan-Meier, reported as median and 95% CI

    Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10


  17. Phase II Response Rate [ Time Frame: At 3, 6, and 9 months and at 1 year after initial treatment ]
    Defined as the proportion of patients with a best overall response of eradicating MRD in this cohort of patients at the time each patient discontinues treatment with Inotuzumab Ozogamicin

  18. Phase II Incidence of myeloid toxicity [ Time Frame: At 1 year ]
    Number of patients who develop myeloid toxicity while on study, defined as grade of anemia, neutropenia and thrombocytopenia CTCAE 4

  19. Phase II Incidence of secondary graft failure [ Time Frame: At 1 year after initial treatment ]

    Number of patients who develop secondary graft failure while on study, defined as:

    Either cytopenias after initial engraftment (ANC <500/µL), with (a) donor chimerism of less than 5% or (b) falling donor chimerism with intervention such as second transplant or donor lymphocyte infusion (DLI) or (c) patient death due to cytopenias, and fall in donor chimerism, even if chimerism was >5%. Exclusion criteria for diagnosis of GF were (a) disease relapse (b) graft versus host disease or (c) other causes of cytopenias such as, viral infections, or drug induced


  20. Phase I incidence of VOD/SOS [ Time Frame: At 1 year ]

    Safety profile of intervention as measured by incidence of VOD/SOS disease in the phase I portion of the study, defined as the occurrence of 2 of the following 3 clinical criteria:

    • Total serum bilirubin level >34 μmol/L (>2.0 mg/dL).
    • An increase in liver size from baseline or development of right upper quadrant pain of liver origin.
    • Sudden weight gain >2.5% during any 72-hour period after infusion of investigational product because of fluid accumulation or development of ascites.

  21. Phase II rate of VOD/SOS - number of participants affected [ Time Frame: At 1 year ]

    Safety profile of intervention as measured by number of participants affected by VOD/SOS disease in the phase I portion of the study, defined as the occurrence of 2 of the following 3 clinical criteria:

    • Total serum bilirubin level >34 μmol/L (>2.0 mg/dL).
    • An increase in liver size from baseline or development of right upper quadrant pain of liver origin.
    • Sudden weight gain >2.5% during any 72-hour period after infusion of investigational product because of fluid accumulation or development of ascites.

  22. Phase II pharmacokinetic (PK) parameters - Cmax (NHL & ALL cohorts) [ Time Frame: At C1D1 (0 hour, 1 hour, 4 hours), C1D7, C2 D1 (0 hour, 1 hour), C4D1 (0 hour, 1 hour) ]

    Phase II PK parameter (NHL & ALL cohorts)

    Cmax is maximum concentration. Descriptive statistics (n, mean, SD, %CV, median, minimum, maximum, geometric mean, its associated geometric %CV) of inotuzumab ozogamicin serum concentrations will be presented in tabular form by cycle, day, nominal time and cohort for the PK concentration analysis population.


  23. Phase II pharmacokinetic (PK) parameters - Ctrough (NHL & ALL cohorts) [ Time Frame: At C1D1 (0 hour, 1 hour, 4 hours), C1D7, C2 D1 (0 hour, 1 hour), C4D1 (0 hour, 1 hour) ]

    Phase II PK parameter (NHL & ALL cohorts)

    Ctrough is lowest concertration of Inotuzumab in the blood.Descriptive statistics (n, mean, SD, %CV, median, minimum, maximum, geometric mean, its associated geometric %CV) of inotuzumab ozogamicin serum concentrations will be presented in tabular form by cycle, day, nominal time and cohort for the PK concentration analysis population.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Phase 1 Acute Lymphoblastic Leukemia Inclusion Criteria

  • 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.
  • Patients who have/are either:

    • Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation

      ---Pre- or Post-Transplant Minimal Residual Disease defined by:

      ----Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication.

    • In second or third complete remission at the time of allogeneic transplantation
    • Treated with reduced intensity regimens or non-myeloablative conditioning regimens
    • Lymphoid blast crisis of CML
    • Are relapsed or refractory to at least 1 line of chemotherapy
    • Philadelphia-like ALL
  • Patients who have evidence of donor chimerism after allogeneic transplantation.
  • ECOG Performance status < 2
  • Participants must have ANC > 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count > 50,000/µL for 7 days.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Participants must have the ability to understand and the willingness to sign a written informed consent document.

Phase 1 Non-Hodgkin's Lymphoma Inclusion Criteria

  • Diagnosis of CD22-positive B-cell Non-Hodgkin's Lymphoma

    -- Patients with 1) Diffuse large B cell lymphoma; 2) Transformed indolent lymphoma; 3) CLL/SLL with Richter's transformation and 4) High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements.Patients must have received an autologous hematopoietic stem cell transplant under one of the following conditions:

    • Achieved partial remission (defined as Deauville 4 on PET/CT) after treatment with platinum - containing salvage regimen;
    • Failed first platinum - containing salvage regimen and achieved complete or partial remission after two separate lines of platinum - containing regimen;
    • Had a second autologous hematopoietic stem cell transplant after achieving complete or partial remission with the first autologous transplant; or
    • Had relapsed or refractory disease involving the bone marrow prior to receiving salvage therapy;
  • The patient's lymphoma must be CD22 positive either by immunohistochemistry or flow cytometry analysis.
  • Patients who are between T+40 and T+100 after autologous transplantation. Patients must receive their first dose of inotuzumab at or before T+100.
  • ECOG Performance status < 2
  • Participants must have ANC > 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count > 50,000/µL for 7 days.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Participants must have the ability to understand and the willingness to sign a written informed consent document.

Phase 2 Acute Lymphoblastic Leukemia Inclusion Criteria

  • 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 who have/are either:

    • Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation

      ---Post-Transplant Minimal Residual Disease defined by:

      ----Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication.

    • In second or third complete remission at the time of allogeneic transplantation
    • Treated with reduced intensity regimens as defined per institutional standard of practice
    • Lymphoid blast crisis of CML
    • Are relapsed or refractory to at least 1 line of chemotherapy
    • Philadelphia-like ALL
  • Patients who have > 80% donor chimerism after allogeneic transplantation.
  • Philadelphia chromosome positive ALL must have failed at least 1 TKI
  • ECOG Performance status < 1
  • pre-transplant evaluation, see 10.1.1
  • Participants must have ANC > 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count > 50,000/µL for 7 days.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Participants must have the ability to understand and the willingness to sign a written informed consent document.

Phase 2 Non-Hodgkin's Lymphoma Inclusion Criteria

  • Patients with 1) Diffuse large B cell lymphoma; 2) Transformed indolent lymphoma; 3) CLL/SLL with Richter's transformation and 4) High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements. Patients must have received an autologous hematopoietic stem cell transplant under one of the following conditions:

    • Achieved partial remission (defined as Deauville 4 on PET/CT) after treatment with platinum - containing salvage regimen;
    • Failed first platinum - containing salvage regimen and achieved complete or partial remission after two separate lines of platinum - containing regimen;
    • Had a second autologous hematopoietic stem cell transplant after achieving complete or partial remission with the first autologous transplant; or
    • Had relapsed or refractory disease involving the bone marrow prior to receiving salvage therapy;
  • The patient's lymphoma must be CD22 positive either by immunohistochemistry or flow cytometry analysis.
  • Patients who are between T+40 and T+100 after autologous transplantation. Patients must receive their first dose of inotuzumab at or before T+100.
  • ECOG Performance status < 1
  • Participants must have ANC > 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count > 50,000/µL for 7 days.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Participants must have the ability to understand and the willingness to sign a written informed consent document.

Phase 1 and 2 Exclusion Criteria:

  • Patients with clinical evidence of disease progression prior to enrollment 4.5.2 Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)
  • For patients with NHL: Active central nervous system or meningeal involvement by lymphoma. Patients with a history of CNS or meningeal involvement must be in a documented remission. For patients with ALL: active central nervous system involvement with ALL.
  • Patients with inadequate organ function as defined by:

    • Creatinine clearance < 30ml/min
    • Bilirubin > 2X institutional upper limit of normal
    • AST (SGOT) > 2X institutional upper limit of normal
    • ALT (SGPT) > 2X institutional upper limit of normal
  • GVHD grade III or IV (for patients with a prior allogeneic transplant).
  • Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)
  • History of VOD
  • Active malignancy
  • Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situationsthat would limit compliance with study requirements.
  • Pregnant or breastfeeding women are excluded from this study because inotuzumab ozogamicin may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with inotuzumab ozogamicin, breastfeeding should be discontinued if the mother is treated with inotuzumab ozogamicin. These potential risks may also apply to other agents used in this study.
  • Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy Serologic statusreflecting active hepatitis B or C infection. Patientsthat are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
  • Participation in any other investigational drug study or had exposure to any other investigational agent, device, or procedure, within 21 days (or 5 half-lives, whichever is greater)
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104491


Contacts
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Contact: Leland Metheny, MD 1-800-641-2422 CTUReferral@UHhospitals.org
Contact: Ron Sobecks, MD 216-444-6833 sobeckr@ccf.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Christina Cho, MD         
Principal Investigator: Christina Cho, MD         
United States, Ohio
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Leland Metheny, MD    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Leland Metheny         
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ronald Sobecks, MD    866-223-8100    TaussigResearch@ccf.org   
Sponsors and Collaborators
Leland Metheny
Investigators
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Principal Investigator: Leland Metheny, MD University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Responsible Party: Leland Metheny, Principal Investigator, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03104491    
Other Study ID Numbers: CASE1916
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leland Metheny, Case Comprehensive Cancer Center:
allogeneic hematopoietic stem cell transplantation
donor chimerism
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Inotuzumab Ozogamicin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antibiotics, Antineoplastic