SUSPENDED

De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis

Conditions

Graft-versus-host Disease Ruxolitinib Graft-versus-host disease prophylaxis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label phase 2 study designed to explore the efficacy and safety of low-dose PTCy-ruxolitinib GVHD prophylaxis in older adults undergoing allogeneic HCT with a matched sibling or unrelated donor with a peripheral blood stem cell graft.

Official Title

A Phase II Trial of De-escalated PTCy and Ruxolitinib for GVHD Prophylaxis in Patients Undergoing Reduced Intensity Conditioning Allogeneic HCT

Quick Facts

Study Start:2023-08-29

Study Completion:2026-09-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT05622318

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. History of hematologic malignancy. 2. Must be in remission: * Acute Leukemia, chronic leukemia, or myelodysplasia/myeloproliferative neoplasm (excluding primary myelofibrosis): No circulating blasts and \<5% blasts in the bone marrow. * Hodgkin and non-Hodgkin lymphomas: Chemo-sensitive disease at time of transplant 3. Patients must have a related or unrelated peripheral blood stem cell donor that is an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donors must be willing to donate peripheral blood stem cells and meet NMDP criteria for donation. 4. Planned reduced intensity conditioning therapy with fludarabine/melphalan, with total dose of melphalan of 100-140 mg/m\^2 IV or fludarabine/busulfan with total dose of busulfan of 6.4 mg/kg IV. 5. Karnofsky Performance Scale of 60 or greater. 6. Male participants must agree to abstinence or to use of barrier contraception during the entire study period. 7. Female participants of childbearing potential will require a negative pregnancy test and should agree to practice two effective methods of contraception during the entire study period. 8. Ability to understand a written informed consent document, and the willingness to sign it.	1. Prior allogeneic HCT or Chimeric antigen receptor (CAR) -T cell therapy. 2. Patients with liver dysfunction evidenced by bilirubin ≥2x upper limit normal (ULN), except for a history of Gilbert syndrome. 3. Patients with renal impairment defined by creatinine\<2mg/dL. 4. Patients with cardiac dysfunction defined by a left ventricular ejection fraction ≤45%. 5. Patients with pulmonary dysfunction defined by a forced expiratory volume in the first second (FEV1) or diffusing capacity for carbon monoxide (DLCO) (corrected for hemoglobin) ≤50% of predicted. 6. Patients with a chronic or active infection requiring systemic treatment during and after transplant. 7. Presence of other active malignant disease diagnosed within 12 months, except for adequately treated non-melanoma skin cancer, adequately treated melanoma grade 2 or less, or cervical intraepithelial neoplasia. Active malignancy is malignancy receiving treatment. 8. Pregnant or lactating subjects.

Inclusion Criteria

Exclusion Criteria

1. History of hematologic malignancy.
2. Must be in remission:
* Acute Leukemia, chronic leukemia, or myelodysplasia/myeloproliferative neoplasm (excluding primary myelofibrosis): No circulating blasts and \<5% blasts in the bone marrow.
* Hodgkin and non-Hodgkin lymphomas: Chemo-sensitive disease at time of transplant
3. Patients must have a related or unrelated peripheral blood stem cell donor that is an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donors must be willing to donate peripheral blood stem cells and meet NMDP criteria for donation.
4. Planned reduced intensity conditioning therapy with fludarabine/melphalan, with total dose of melphalan of 100-140 mg/m\^2 IV or fludarabine/busulfan with total dose of busulfan of 6.4 mg/kg IV.
5. Karnofsky Performance Scale of 60 or greater.
6. Male participants must agree to abstinence or to use of barrier contraception during the entire study period.
7. Female participants of childbearing potential will require a negative pregnancy test and should agree to practice two effective methods of contraception during the entire study period.
8. Ability to understand a written informed consent document, and the willingness to sign it.

1. Prior allogeneic HCT or Chimeric antigen receptor (CAR) -T cell therapy.
2. Patients with liver dysfunction evidenced by bilirubin ≥2x upper limit normal (ULN), except for a history of Gilbert syndrome.
3. Patients with renal impairment defined by creatinine\<2mg/dL.
4. Patients with cardiac dysfunction defined by a left ventricular ejection fraction ≤45%.
5. Patients with pulmonary dysfunction defined by a forced expiratory volume in the first second (FEV1) or diffusing capacity for carbon monoxide (DLCO) (corrected for hemoglobin) ≤50% of predicted.
6. Patients with a chronic or active infection requiring systemic treatment during and after transplant.
7. Presence of other active malignant disease diagnosed within 12 months, except for adequately treated non-melanoma skin cancer, adequately treated melanoma grade 2 or less, or cervical intraepithelial neoplasia. Active malignancy is malignancy receiving treatment.
8. Pregnant or lactating subjects.

Contacts and Locations

Principal Investigator

Sameem Abedin, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Sameem Abedin, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-29

Study Completion Date2026-09-15

Study Record Updates

Study Start Date2023-08-29

Study Completion Date2026-09-15

Terms related to this study

Keywords Provided by Researchers

Graft-versus-host disease
Ruxolitinib
Graft-versus-host disease prophylaxis

Additional Relevant MeSH Terms

Graft-versus-host Disease