Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-02617 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10421 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01FD006836 | U.S. FDA Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase II trial studies how well ustekinumab works in preventing acute graft-versus-host disease after unrelated donor hematopoietic cell transplant. Sometimes the transplanted cells from a donor can attack the body's normal tissues (called graft-versus-host disease). Giving ustekinumab after the transplant may help prevent acute graft-versus-host disease by controlling the body's immune response. Funding Source- FDA OOPD.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Between 4 and 72 hours prior to start of HCT conditioning therapy, patients receive ustekinumab intravenously (IV). Beginning 8 weeks after receiving IV ustekinumab, patients receive ustekinumab subcutaneously (SC) on days 50 (+/- 5 days), 100 (+/- 7 days), and 160 (+/- 7 days) post-HCT in the absence of grade III-IV acute GVHD, disease relapse or unacceptable toxicity. NOTE: HCT infusion takes place on day 0.
ARM II: Between 4 and 72 hours prior to start of HCT conditioning therapy, patients receive a placebo IV. Beginning 8 weeks after IV placebo, patients receive a placebo SC on days 50 (+/- 5 days), 100 (+/- 7 days), and 160 (+/- 7 days) post-HCT in the absence grade III-IV acute GVHD, of disease relapse, or unacceptable toxicity. NOTE: HCT infusion takes place on day 0.
After completion of study, patients are followed up at 6, 9, 12, 18, and 24 months post-HCT.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (ustekinumab) | Experimental | Between 4 and 72 hours prior to start of HCT conditioning therapy, patients receive ustekinumab IV. Beginning 8 weeks after receiving IV ustekinumab, patients receive ustekinumab SC on days 50 (+/- 5 days), 100 (+/- 7 days), and 160 (+/- 7 days) post-HCT in the absence of grade III-IV acute GVHD, disease relapse or unacceptable toxicity. NOTE: HCT infusion takes place on day 0. |
|
| Arm II (placebo) | Placebo Comparator | Between 4 and 72 hours prior to start of HCT conditioning therapy, patients receive a placebo IV. Beginning 8 weeks after IV placebo, patients receive a placebo SC on days 50 (+/- 5 days), 100 (+/- 7 days), and 160 (+/- 7 days) post-HCT in the absence of grade III-IV acute GVHD, disease relapse, or unacceptable toxicity. NOTE: HCT infusion takes place on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Administration | Drug | Given IV and SC |
| |
| Quality-of-Life Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Grade II-IV acute graft versus host disease (GVHD) survival | Will be treated as a binary outcome, and the Cochran-Mantel-Haenszel test will be used to compare the two groups based on the stratification factors. | At 6 months post-hematopoietic cell transplantation (HCT) |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of grade II-IV and grade III-IV acute GVHD | At 100 days post-HCT | |
| Cumulative incidence of grade II-IV and grade III-IV acute GVHD | At 6 months post-HCT | |
Not provided
Inclusion Criteria:
Age 18 - 70
Signed informed consent.
Hematologic malignancy or disorder requiring allogeneic hematopoietic cell transplantation
Adequate vital organ function:
Performance status: Karnofsky Performance Status Score ≥ 70%.
HCT donor is at least 8/8 (matched at HLA-A, -B, -C, -DRB1) matched with the recipient
PBSC (peripheral blood mobilized stem cells) as graft source
Fully myeloablative, reduced-toxicity ablative, or reduced-intensity conditioning regimens. If melphalan is part of the conditioning regimen, dose must be at least 75mg/m^2
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephanie J. Lee | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center, | Duarte | California | 91010 | United States | ||
| H. Lee Moffitt Cancer Center & Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 3, 2023 | May 22, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Ustekinumab | Biological | Given IV and SC |
|
|
| Acute GVHD organ staging, overall grading, and classification |
Minnesota risk criteria will be used to assess organ involvement, individual organ staging, and overall acute GVHD grade. Risk classification will be performed per MacMillan et al. |
| From time of HCT, assessed up to day 100 post-HCT |
| Incidence of overall chronic GVHD | Will be assessed at serial study visits, and scored according to National Institutes of Health Consensus criteria. | From time of HCT, assessed up to 2 years post-HCT |
| Incidence of moderate-severe chronic GVHD | Will be assessed at serial study visits, and scored according to National Institutes of Health Consensus criteria. | From time of HCT, assessed up to 2 years post-HCT |
| Incidence of post-HCT relapse | Relapse is defined as hematologic relapse or any unplanned intervention (including withdrawal of immune suppression) to prevent progression of disease in patients with evidence (molecular, cytogenetic, flow cytometric, radiographic) of malignant disease. Will be compared using either the log-rank test (if no competing risks) or Gray's test (if competing risks are present). For time-to-event endpoints with competing risks, the log-rank test will also be used for exploratory purposes. | From time of HCT, assessed up to 2 years post-HCT |
| Incidence of non-relapse mortality | Non-relapse mortality indicates death with primary malignancy that served as HCT indication in remission. Will be compared using either the log-rank test (if no competing risks) or Gray's test (if competing risks are present). For time-to-event endpoints with competing risks, the log-rank test will also be used for exploratory purposes. | From time of HCT, assessed up to 2 years post-HCT |
| Relapse-free survival | Relapse is defined as hematologic relapse or any unplanned intervention (including withdrawal of immune suppression) to prevent progression of disease in patients with evidence (molecular, cytogenetic, flow cytometric, radiographic) of malignant disease. Will be compared using either the log-rank test (if no competing risks) or Gray's test (if competing risks are present). For time-to-event endpoints with competing risks, the log-rank test will also be used for exploratory purposes. | From time of HCT, assessed up to 2 years post-HCT |
| Overall survival | Will be compared using either the log-rank test (if no competing risks) or Gray's test (if competing risks are present). For time-to-event endpoints with competing risks, the log-rank test will also be used for exploratory purposes. | From time of HCT, assessed up to 2 years post-HCT |
| Tampa |
| Florida |
| 33612 |
| United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| D007074 | Immunoglobulin G |
| D053762 | Interleukin-12 Subunit p40 |
| D004220 | Disulfides |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007132 | Immunoglobulin Isotypes |
| D018664 | Interleukin-12 |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D053759 | Interleukin-23 |
| D001685 | Biological Factors |
| D013440 | Sulfides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006862 | Hydrogen Sulfide |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided