Status:
COMPLETED
Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Amgen
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-70 years
Phase:
PHASE2
Brief 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 allo...
Detailed Description
Study Drug Administration: Every study cycle will be 6 weeks. You may receive up to 4 cycles of blinatumomab. Each cycle will start around 3, 6, 9, and 12 months after your stem cell transplant. In ...
Eligibility Criteria
Inclusion
- 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 \< 5 x ULN and serum bilirubin \< 3 x ULN.
- Performance status of 0, 1, or 2. Karnofsky (or Lansky for subjects \< 16 years old) performance status \>/= 50.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02807883
Start Date
August 1 2016
End Date
February 1 2022
Last Update
January 20 2023
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030