Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 16 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests safe doses and side effects of inotuzumab ozogamicin after a stem cell transplant from a donor. It is for people with CD22-positive acute lymphoblastic leukemia (ALL), a blood cancer, who meet certain risk rules. The drug combines an antibody with chemotherapy and is experimental in this study.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have ALL with a marker called CD22 and have had a stem cell transplant from a donor.
- Be 40 to 100 days past the transplant. In Phase 1, the first study dose must be given by day 100.
- Meet at least one risk rule: small amounts of ALL remain near transplant during a first remission; be in a second or third remission at transplant; have had a lower-strength transplant treatment; have CML in lymphoid blast crisis; have ALL that returned or resisted chemotherapy; or have Philadelphia-like ALL. Remission means cancer signs have gone away. Rules differ slightly by phase.
- Have blood-forming cells from the donor. In Phase 2, more than 80% must be from the donor.
- For Phase 2, people with Philadelphia chromosome-positive ALL must have tried at least one targeted drug called a TKI that did not work.
- Be fully active or limited only in hard physical activity for Phase 1. Be fully active for Phase 2.
- Have infection-fighting white blood cells above 1,000/µL for 3 days. Have platelets, which help stop bleeding, above 50,000/µL for 7 days without platelet transfusions.
- Be able to follow study visits and rules, understand the study, and sign a consent form.
Who can't join
- Cancer is getting worse before joining, or side effects from past treatment are still moderate or worse. Some exceptions apply, such as hair loss or nerve damage.
- Have kidney filtering below 30 mL/min, or certain liver blood tests more than twice the lab’s normal upper limit.
- Have severe graft-versus-host disease (donor cells attacking the body), any active form of this disease in the liver, or a history of blocked small liver veins called VOD.
- Take a TKI or sirolimus during the study, or have a known allergy or intolerance to study drugs or their ingredients.
- Have another active cancer, except non-melanoma skin cancer or cancer that has not spread beyond its starting layer. Also excluded: bone marrow findings showing myelodysplasia, a problem with making healthy blood cells.
- Have an uncontrolled illness, such as an infection or certain heart problems, or another condition that makes participation unsafe or difficult. Active hepatitis B or C is excluded; people with positive screening blood tests must have a negative PCR test for the virus.
- Be pregnant or breastfeeding.
- Have joined another experimental drug study or used an experimental drug, device, or procedure too recently: within 21 days, or longer if needed for five drug half-lives to pass.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Phase 1 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 2 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 1 and 2 Exclusion Criteria: * 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.) * 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 * Use of concomitant TKI or sirolimus * Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) * 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. * 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 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.) * 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.) * 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
Study sites (7)
KS
- The University of Kansas Cancer Center · Westwood, KS 66205More trials in Westwood
MA
- Dana-Farber Cancer Institute · Boston, MA 02215Roman Shapiro, MD · Study contact · Roman_Shapiro@DFCI.HARVARD.EDUMore trials in Boston
NE
- University of Nebraska Medical Center · Omaha, NE 68106Vijaya Bhatt, MD · Study contact · Vijaya.bhatt@unmc.eduMore trials in Omaha
NY
- Memorial Sloan Kettering Cancer Center · New York, NY 10065More trials in New York
OH
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center · Cleveland, OH 44106-5065Leland Metheny, MD · Study contact · 800-641-2422 · CTUReferral@UHhospitals.orgLeland Metheny · Principal investigatorMore trials in Cleveland
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center · Cleveland, OH 44195More trials in Cleveland
- The James Cancer Hospital and Solove Research Institute · Columbus, OH 43210Jiasheng Wang, MD · Study contactJiasheng Wang, MD · Principal investigatorMore trials in Columbus