NCT03850366 HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib
| NCT ID | NCT03850366 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Henry Ford Health System |
| Condition | Hematological Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2016-03-08 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2016-03-08 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Now haplo stem cell transplant using bone marrow or peripheral blood is becoming more feasible with better regimens to prevent graft versus host disease (GVHD) like post transplant cyclophosphamide , tacrolimus, mycophenolate . Recently Bortezomib has also been shown to inhibit dendritic cells maturation and function and possesses a number of other favorable immunomodulatory effect that can prevent GVHD and help enhance immune reconstitution. this study is to assess the engraftment rate in patients with hematologic malignancies who need allogeneic stem cell transplant but do not have a suitable matched related or unrelated stem cell donor and will get T-cell replete HLA-Haploidentical allogeneic peripheral stem cell transplantation using post transplant Cyclophosphamide and bortezomib
Eligibility Criteria
Inclusion Criteria: * 18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\</= 7/8 allele match at the A, B, C, DR loci with a minimum match of 5/10 is required) is identified * Candidate for stem cell transplant in a malignant hematological condition * Karnofsky Performance Scale 0-1 * Available donor able to undergo a Peripheral blood stem cells collection * Bilirubin \</= 1.5 mg/dl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \</= 200 IU/ml for adults. * Serum creatinine clearance \>/=60 ml/min (calculated with Cockroft-Gault formula) * Diffusing capacity for carbon monoxide (DLCO) \>/= 45% predicted corrected for hemoglobin. * Left ventricle ejection fraction \> 40%. * Patient or patient's legal representative, parent(s) or guardian should provide written informed consent. Exclusion Criteria: * Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8/8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7/8 related or unrelated donor available within 42 days of search initiation * HIV positive; active hepatitis B or C * Patients with active uncontrolled infections. * Liver cirrhosis * Uncontrolled central nervous system involvement by tumor cells * Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. * Inability to comply with medical therapy or follow-up
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03850366 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hematological Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03850366 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03850366 currently recruiting?
Yes, NCT03850366 is actively recruiting participants. Contact the research team at sfarhan1@hfhs.org for enrollment information.
Where is the NCT03850366 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT03850366 clinical trial?
NCT03850366 is sponsored by Henry Ford Health System. The trial plans to enroll 15 participants.