RECRUITING

Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

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Conditions

Acute Lymphocytic Leukemiaallogeneic hematopoietic stem cell transplantationdonor chimerism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

Quick Facts

Study Start:2017-07-31
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03104491

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
  2. * Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia
  3. * 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.
  4. * Patients who have/are either:
  5. * Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation
  6. * In second or third complete remission at the time of allogeneic transplantation
  7. * Treated with reduced intensity regimens or non-myeloablative conditioning regimens
  8. * Lymphoid blast crisis of CML
  9. * Are relapsed or refractory to at least 1 line of chemotherapy
  10. * Philadelphia-like ALL
  11. * Patients who have evidence of donor chimerism after allogeneic transplantation.
  12. * ECOG Performance status \< 2
  13. * 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.
  14. * Able to adhere to the study visit schedule and other protocol requirements.
  15. * Participants must have the ability to understand and the willingness to sign a written informed consent document.
  16. * Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
  17. * Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia
  18. * Patients who are between T+40 and T+100 after allogeneic transplantation
  19. * Patients who have/are either:
  20. * Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation
  21. * In second or third complete remission at the time of allogeneic transplantation
  22. * Treated with reduced intensity regimens as defined per institutional standard of practice
  23. * Lymphoid blast crisis of CML
  24. * Are relapsed or refractory to at least 1 line of chemotherapy
  25. * Philadelphia-like ALL
  26. * Patients who have \> 80% donor chimerism after allogeneic transplantation.
  27. * Philadelphia chromosome positive ALL must have failed at least 1 TKI
  28. * ECOG Performance status \< 1
  29. * pre-transplant evaluation, see 10.1.1
  30. * 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.
  31. * Able to adhere to the study visit schedule and other protocol requirements.
  32. * Participants must have the ability to understand and the willingness to sign a written informed consent document.
  1. * Patients with clinical evidence of disease progression prior to enrollment
  2. * Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)
  3. * Patients with inadequate organ function as defined by:
  4. * Creatinine clearance \< 30ml/min
  5. * Bilirubin \> 2X institutional upper limit of normal
  6. * AST (SGOT) \> 2X institutional upper limit of normal
  7. * ALT (SGPT) \> 2X institutional upper limit of normal
  8. * GVHD grade III or IV (for patients with a prior allogeneic transplant).
  9. * Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)
  10. * History of VOD
  11. * Use of concomitant TKI or sirolimus
  12. * Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)
  13. * 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 situations that would limit compliance with study requirements.
  14. * 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.
  15. * Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy Serologic status reflecting active hepatitis B or C infection. Patients that 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.)
  16. * Serologic status reflecting active hepatitis B or C infection. Patients that 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.)
  17. * 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)
  18. * 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.
  19. * Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds

Contacts and Locations

Study Contact

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

Principal Investigator

Leland Metheny, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Locations (Sites)

The University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68106
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
United States
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Leland Metheny

  • Leland Metheny, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-07-31
Study Completion Date2026-05

Study Record Updates

Study Start Date2017-07-31
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • allogeneic hematopoietic stem cell transplantation
  • donor chimerism

Additional Relevant MeSH Terms

  • Acute Lymphocytic Leukemia