Reduced intensity transplant protocol for hematologic malignancies
A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies
Northside Hospital, Inc. · NCT05417971
This study is testing a gentler transplant method using a specific combination of medications and radiation to see if it helps patients with blood cancers who have a matched donor.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northside Hospital, Inc. (other) |
| Drugs / interventions | fludarabine |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05417971 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and efficacy of a reduced intensity conditioning protocol using fludarabine and intermediate-dose total body irradiation (TBI) prior to haplo-identical transplantation. The study focuses on patients with hematologic malignancies who have a matched related donor willing to provide peripheral blood stem cells. The approach aims to assess the outcomes of this transplant method in patients at high risk of relapse following non-myeloablative conditioning. The trial will monitor patient responses and potential complications associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with hematologic malignancies requiring allogeneic transplantation and having a suitable matched related donor.
Not a fit: Patients with significant comorbidities or those who do not have a matched donor may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve transplant outcomes and reduce relapse rates in patients with hematologic malignancies.
How similar studies have performed: Other studies have shown promise with reduced intensity conditioning protocols, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells * KPS \>/= 70% * Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning. Exclusion Criteria: * Poor cardiac function (LVEF \<45%) * Poor pulmonary function (FEV, FVC, DLCO \<60%) * Poor liver function (bilirubin \>/= 2.5mg/dL; AST or ALT \>3xULN) * Poor renal function (creatinine clearance \<40mL/min) * HIV-positive; active HepB or HepC * Uncontrolled infection * Pregnant female or not able to practice adequate contraception * Debilitating medical or psychiatric illness which would preclude their giving informed consent
Where this trial is running
Atlanta, Georgia
- Caitlin Guzowski — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Scott Solomon, MD — BMTGA
- Study coordinator: Stacey Brown
- Email: stacey.brown@northside.com
- Phone: 404-480-7965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematologic Malignancy