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New treatment option for Acute Lymphocytic Leukemia
Official title Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT03104491
What this study is testing
What is Inotuzumab Ozogamicin?
Inotuzumab Ozogamicin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphocytic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 75
You may be able to join if
- Phase 1 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-...
You likely can't join if
- 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
See the full eligibility criteria
- Phase 1 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...
- 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 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
The study team makes the final eligibility decision.
Where it's taking place
- Westwood, Kansas, United States
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Westwood, Kansas, United States; Boston, Massachusetts, United States; Omaha, Nebraska, United States; New York, New York, United States; Cleveland, Ohio, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.