BLinatumomab and iNKT in Relapsed B-Cell ALL

Browse trials for

• Burkitt Lymphoma 407
• Neoplasm, Residual 272
• Disease Progression 551

Keywords

• Residual disease
• disease progression
• progressive disease
• genT-797
• natural killer T-cell (iNKT) therapy
• cell therapy
• natural killer cell therapy

Burkitt Lymphoma

407 studies on the registry are indexed under Burkitt Lymphoma; 117 are open to participants now.

This study's planned enrollment of 13 is below the median of 40 across 363 interventional studies indexed under Burkitt Lymphoma.

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 424 studies on the registry; 96 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.

Study arms

• Experimental
  Blinatumomab-resistant/progressive B-ALL

  Patients with CD19-positive, Philadelphia chromosome-negative B-ALL with disease progression during blinatumomab therapy, including patients who become MRD-positive after achieving prior MRD negativity or who experience frank relapse.

  Biological: Invariant Natural Killer T Cell Therapy

Interventions

• BiologicalInvariant Natural Killer T Cell Therapy

  AgenT-797 is an investigational invariant natural killer T (iNKT) cell therapy administered as a single intravenous infusion in combination with blinatumomab.

Primary outcomes

1. Number of participants with Grade 3 or higher Treatment Related Adverse Events -CTCAE

   Number of participants with Grade 3 or higher Treatment Related Adverse Events based on The NCI Common Terminology Criteria for Adverse Events (CTCAE) will be reported. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

   Time frame: Up to 9 months

2. Number of participants with Grade 3 or higher Treatment Related Adverse Events - cytokine release syndrome (CRS)

   CRS will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild: Fever ≥38\^ o C, No hypotension, No hypoxia, Grade 2 - Moderate: Fever ≥38\^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe: Fever ≥ 38\^ o C, Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (\>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening: Fever ≥38\^oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation, mechanical ventilation), Grade 5 - Death

   Time frame: Up to 9 months

3. Number of participants with Grade 3 or higher Treatment Related Adverse Events - Neurological Toxicity (ICANS)

   Immune effector cell-associated neurotoxicity syndrome (ICANS) symptoms will be graded according to the criteria outlined in the protocol on a scale from 1 (mild) to 4 (critical). Cytokine release syndrome (CRS) will be graded according to criteria outlined in the protocol on a scale from 1 (mild) to grade 5 (death).

   Time frame: Up to 9 months

Secondary outcomes

1. The effectiveness of the combination therapy

   The effectiveness of the combination therapy will be evaluated according to disease status at study entry. Among participants with frank hematologic relapse, efficacy will be defined as a reduction in bone marrow leukemic blasts to \<5% after the first cycle of combination therapy. Among participants with measurable residual disease (MRD) without frank relapse, efficacy will be assessed by the proportion of participants achieving MRD negativity by multiparameter flow cytometry and/or demonstrating a decrease in MRD level from baseline. Among participants with extramedullary disease, efficacy will be assessed by the proportion achieving PET negativity after therapy and, where applicable, by changes in physical examination measurements of skin or superficial extramedullary involvement.

   Time frame: Up to 9 months

2. Extramedullary disease response

   Extramedullary disease response is defined by resolution of Positron Emission Tomography (PET)-detectable disease on Positron Emission Tomography/Computed Tomography (PET/CT) imaging for participants with PET-avid extramedullary disease at baseline, or reduction in the size of skin or other superficial extramedullary lesions based on physical examination.

   Time frame: Up to 42 days (after Cycle 1)

3. Change in residual B-cell acute lymphoblastic leukemia (B-ALL)

   Change in residual B-cell acute lymphoblastic leukemia (B-ALL) detected by the clonoSEQ assay, measured by immunoglobulin sequence tracking from baseline to follow-up in participants with available diagnostic samples. ClonoSEQ® assay is a laboratory test used to detect and tracking unique leukemia cell DNA sequences.

   Time frame: Up to 9 months

4. Event-Free Survival (EFS)

   Event-Free Survival (EFS) is defined as the time from treatment initiation to MRD relapse, clinical relapse, disease progression, or death. Participants will be followed for up to 7 months through study assessments and up to 18 months through medical record review.

   Time frame: Up to 18 months

5. Overall Survival (OS)

   Overall Survival (OS) is defined as the time from treatment initiation to death from any cause. Participants will be followed for up to 18 months after study initiation.

   Time frame: Up to 18 months

Related links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials ↗

Individual participant data

Plan to share: Yes — De-identified data may be shared with approved researchers and industry partners one year after completion of the study.