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Stem Cell Transplantation

Allogeneic hematopoietic stem cell graft using an allogeneic SCT HLA-Identical or non-identical family donor or unrelated donors for Graft Failure

Phase 2
Waitlist Available
Led By Mark W Brunvand, MD
Research Sponsored by Colorado Blood Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overall management of acute and chronic gvhd
Awards & highlights

Study Summary

Major Objectives A. To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients who have rejected (<5% T Cell Chimerism) a previous allogeneic hematopoietic stem cell graft by using an allogeneic SCT from an HLA-Identical or non-identical family donor or unrelated donors, with fludarabine (150mg/m2) and TBI (400cGy), with post-transplantation immunosuppression utilizing tacrolimus and MMF. B. To evaluate the incidence of transplant related mortality. Minor Objectives A. To evaluate the incidence of acute and chronic GVHD after second allogeneic HCT utilizing Tac/MMF with peripheral blood stem cells from matched or mis-matched allogeneic donors. B. To evaluate disease responses and survival after second allogeneic SCT. C. To evaluate the need for DLI after second transplant for either disease control or persistent mixed chimerism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overall disease free survival
This trial's timeline: 3 weeks for screening, Varies for treatment, and overall disease free survival for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stable allogeneic hematopoietic engraftment with fludarabine (150mg/m2) and TBI (400cGy), with post-transplantation immunosuppression utilizing tacrolimus and MMF.
Secondary outcome measures
Incidence of acute and chronic GVHD after second allogeneic HCT utilizing Tac/MMF with peripheral blood stem cells from matched or mis-matched allogeneic donors, disease responses and survival after second allogeneic SCT.

Trial Design

1Treatment groups
Active Control
Group I: Fludarabine and 400cGY TBIActive Control3 Interventions

Find a Location

Who is running the clinical trial?

Colorado Blood Cancer InstituteLead Sponsor
3 Previous Clinical Trials
110 Total Patients Enrolled
Mark W Brunvand, MDPrincipal InvestigatorColorado Blood Cancer Institute
1 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

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~1 spots leftby Apr 2025