Phase 2
N=23
Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02807883 ↗Enrolled (actual)
23
Serious AEs
21.7%
Results posted
Jan 2023
Primary outcome: Primary: Number of Participants With Toxicities — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Blinatumomab (Drug); Hematopoietic Cell Transplantation (Procedure)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Toxicities |
— | — |
| SECONDARY Progression Free Survival (PFS) |
15 | — |
| SECONDARY Overall Survival (OS) |
18 | — |
Summary
You are being asked to take part in this study because you either had Ph positive B-lineage acute lymphoblastic leukemia (ALL) or still have a small amount of the disease and recently received an allogeneic stem cell transplant (cells from someone else).
The goal of this clinical research study is to learn if blinatumomab in patients who have had an allogeneic stem cell transplant can help to control ALL or prevent ALL from coming back in patients who either have a small amount of ALL or have had ALL in the past. The safety of this drug will also be studied.
Eligibility Criteria
Inclusion Criteria
- Patients 1-70 years of age.
- Patients with B-lineage ALL in a) hematologic complete remission (CR) beyond CR1 at time of transplant; patients beyond CR1 or with primary induction failure may be without minimal residual disease, b) any residual disease defined by positive flow >0.01%, detection of BCR-ABL transcript by PCR with a sensitivity of 1/10,000, or detection of the t(9;22) translocation in any metaphases by cytogenetics at time of transplant, or presence of the MLL gene.
- Received an allogeneic HCT within the last 100 days. Enrollment within 30-100 days after transplant, and after adequate recovery of counts defined as ANC >/= 0.5 x 10^9/L without daily use of myeloid growth factor and platelet > 20 x 10^9/L without platelet transfusion within 1 week, and adequate organ function to receive blinatumomab defined as creatinine clearance greater than 30 ml/min, ALT/AST /= 50.
Exclusion Criteria
- Relapsed ALL defined as >5% malignant blasts in bone marrow or peripheral blood.
- Active GVHD requiring systemic steroid therapy. Medications for GVHD prophylaxis are acceptable.
- Systemic steroid therapy unless for physiologic replacement
- Uncontrolled disease/infection as judged by the treating physician
- Active ALL in the central nervous system (CNS), as defined by >/= 5 leukocytes per microL with identifiable blast cells in the CSF, and/or the presence of cranial-nerve palsies
- Pregnant or nursing women
Data sourced from ClinicalTrials.gov (NCT02807883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.