Phase 2
N=45
B Cell Induction in Pediatric Lung Transplantation
Lung Transplant
Bottom Line
View on ClinicalTrials.gov: NCT02266888 ↗Enrolled (actual)
45
Serious AEs
62.2%
Results posted
Jul 2020
Primary outcome: Primary: Earliest Time to Any of the Following Events: Chronic Allograft Dysfunction, Listed for Retransplant or Death — NA; 703 Days — p=0.514
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab (Rituxan®) (Biological); Placebo (Biological)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Earliest Time to Any of the Following Events: Chronic Allograft Dysfunction, Listed for Retransplant or Death |
NA; 703 | 0.514 |
| SECONDARY Percent of Participants Diagnosed With Chronic Allograft Dysfunction |
28.6; 27.3 | — |
| SECONDARY Percent of Participants Listed for Re-Transplant During the Study Follow-Up Period |
0; 8.3 | — |
| SECONDARY Percent of Participants Who Died During the Study Follow-Up Period |
13.3; 25.0 | — |
| SECONDARY Percent of Participants With Primary Graft Dysfunction (PGD) |
25.0; 14.3 | >0.999 |
| SECONDARY Percent of Participants With Occurrence of Grade A Acute Rejection |
13.3; 16.7 | >0.999 |
| SECONDARY Percent of Participants With Occurrence of Antibody Mediated Rejection |
0; 16.7 | 0.188 |
| SECONDARY Percent of Participants Meeting Tacrolimus Variability Threshold |
93.3; 100 | — |
| SECONDARY Percent of Participants Meeting Tacrolimus Variability Threshold Who Completed Tacrolimus Variability Intervention |
85.7; 100 | — |
| SECONDARY Magnitude of Change in Standard Deviation of Tacrolimus Levels Following Intervention |
3.95; 5.18; 3.03; 2.86 | 0.015 sig |
| SECONDARY Percent of Participants Experiencing an Infection Episode |
100; 100 | — |
| SECONDARY Number of Participants With Severity of Infection Episodes |
4; 4; 8; 7; 1; 0 | 0.502 |
| SECONDARY Percent of Participants Experiencing a Serious Adverse Event (SAE) Related to Rituximab |
73.3; 58.3 | 0.448 |
Summary
In this study, doctors are trying to see if a study drug called rituximab (Rituxan®) will lower the number of B cells in the body. Doctors are also trying to see if decreasing B cells with rituximab (Rituxan®) can prevent injury to the transplanted lung. This treatment has been studied in other types of solid organ transplants.
Eligibility Criteria
Inclusion Criteria
Enrollment:
- Subject and/or parent guardian must be able to understand and provide informed consent;
- Candidate for a primary lung transplant (listed for lung transplant);
- Female and male subjects with reproductive potential must agree to use FDA approved methods of birth control for 12-months after completion of treatment.
- Adequate bone marrow functions based on the following criteria:
- Absolute neutrophil count (ANC): >1000mm^3
- Platelets: >100,000/mm^3
- Hemoglobin: >7 gm/dL
- AST or ALT 2 months) and/or IVIG replacement therapy;
- Positive blood culture, sepsis or other disease process with hemodynamic instability at time of enrollment;
- Any history of serologic positivity to HIV, HBsAg, HBcAb and HCV Ab;
- History of malignancy less than 2 years in remission of malignancy (any history of adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin will be permitted);
- Any condition, including psychiatric disorders, that in the opinion of the investigator would interfere with the subject's ability to comply with study requirements;
- Participation in another investigational trial within 4 weeks of enrollment;
- Currently lactating or plans to become pregnant during the timeframe of the study follow-up period;
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Randomization:
Individuals who meet any of these criteria are not eligible for randomization:
- Use of an induction agent other than Thymoglobulin®;
- Renal insufficiency requiring hemodialysis or ultrafiltration;
- Inability to obtain intravenous access;
- Positive blood culture, sepsis or other disease process with hemodynamic instability at time of transplant;
- Use of investigational agent(s) within 5 half-lives of the investigational drug or 4 weeks, whichever is longer;
- Receipt of a MMR vaccine within 30 days prior to randomization;
- Any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.
Data sourced from ClinicalTrials.gov (NCT02266888). 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.