Clinical trial · Interventional
Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinatumomab | Drug | Blinatumomab | ALIAS |
| Hematopoietic Cell Transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blinatumomab
- description
- Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT).
- interventionNames
- Drug: Blinatumomab
- Procedure: Hematopoietic Cell Transplantation
Primary outcomes (1)
- measure
- Number of Participants With Toxicities
- timeFrame
- 30 days from the first cycle
- description
- Participants with treatment-related toxicities attributable to Blinatumomab. Toxicities defined as any 1) grade 3-4 acute GVHD greater than 30%, 2) secondary graft failure \>30%, or 3) nonrelapse mortality (NRM) within one cycle of Blinatumomab.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients 1-70 years of age. 2. 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. 3. 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. 4. Performance status of 0, 1, or 2. Karnofsky (or Lansky for subjects \< 16 years old) performance status \>/= 50. Exclusion Criteria: 1. Relapsed ALL defined as \>5% malignant blasts in bone marrow or peripheral blood. 2. Active GVHD requiring systemic steroid therapy. Medications for GVHD prophylaxis are acceptable. 3. Systemic steroid therapy unless for physiologic replacement 4. Uncontrolled disease/infection as judged by the treating physician 5. 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 6. Pregnant or nursing women
References
Publications (1)
- DERIVEDGaballa MR, Banerjee P, Milton DR, Jiang X, Ganesh C, Khazal S, Nandivada V, Islam S, Kaplan M, Daher M, Basar R, Alousi A, Mehta R, Alatrash G, Khouri I, Oran B, Marin D, Popat U, Olson A, Tewari P, Jain N, Jabbour E, Ravandi F, Kantarjian H, Chen K, Champlin R, Shpall E, Rezvani K, Kebriaei P. Blinatumomab maintenance after allogeneic hematopoietic cell transplantation for B-lineage acute lymphoblastic leukemia. Blood. 2022 Mar 24;139(12):1908-1919. doi: 10.1182/blood.2021013290. PMID 34914826