Clinical Trial: Donor Stem Cell Boost in Treating Patients With Low Blood Cells After Donor Stem Cell Transplant

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Compassionate Use of the CliniMACS® CD34 Reagent System for Patients Requiring a Post Hematopoietic Stem Cell Transplant Boost of Donor Hematopoietic Stem Cells

Brief Summary: This clinical trial studies how well donor stem cell boost works in treating patients with low blood cells after donor stem cell transplant. Donor stem cell boost may increase low blood cell counts caused by hematologic cancer or its treatment.

Detailed Summary:

Successful engraftment after allogeneic hematopoietic stem cell transplant (HSCT) is defined by an actual neutrophil count (ANC) of > 500 10^6/L and a self-sustaining platelet count of 20 x 10^9/L. ANC recovery usually occurs 14 to 21 days after the infusion of donor HSCs with red cell and platelet recovery typically following within the same time frame, although resolution of anemia may occur last. Recovery time is dose dependent, but in one report, donor HSC aliquots containing 1.9 to 20.5 10^6/kg CD34+ cells resulted in an ANC of > 500 10^6/L at a median of 12 days and 16 days for patients receiving filgrastim versus those not receiving a white cell growth factor. In this trial, self-sustaining platelet counts of 20 x 10^9/L occurred at median times of 15 to 11 days respectively. The results of another trial comparing outcomes between patients receiving mobilized peripheral blood stem cells (PBSCs) versus those receiving marrow from their donors showed that median times ANC of > 500 10^6/L and self-sustaining platelet counts of 20 x 10^9/L were 16 and 13 days respectively in the group receiving PBSCs and 21 and 19 days in those receiving marrow. Similar HSC doses associated with successful engraftment in these time frames have been demonstrated in other trials.

Most transplant centers require a minimum dose of 1 to 2 x 10^6 CD34+ cells/kg to achieve adequate count recovery in a reasonable time frame post HSCT, although an early trial examining recovery after autologous reinfusion of HSCs demonstrated that a threshold of 2.5 x 10^6/kg of CD 34 cells was associated with consistent and rapid WBC and platelet recovery times (18 and 14 days respectively). A later trial assessing autologous PBSC mobilization in breast cancer patients showed that HSC doses of ≥ 5 x 10^6 CD34+ cells/kg were associated with an 85% probability of WBC and platelet recovery by day 1
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Current Primary Outcome:

  • Etiologies of post HSCT cytopenias [ Time Frame: Up to 8 weeks ]
    Will be collected and reported descriptively.
  • CD34+/kg and CD3+/kg cell doses in the infused CD 34+ selected boost products [ Time Frame: Up to 8 weeks ]
    Will be collected and reported descriptively.
  • Effects of the CD 34+ selected boost on peripheral blood cell counts [ Time Frame: Up to 8 weeks ]
    Will be collected and reported descriptively.
  • Incidence of GVHD related to the CD34+ selected boost [ Time Frame: Up to 8 weeks ]
    Will be collected and reported descriptively.
  • Incidence of grade 3-5 infusion reactions, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 [ Time Frame: Up to 8 weeks ]
    Will be descriptive.
  • Incidence of severe GVHD (grades 3-4), graded according to standard criteria [ Time Frame: Up to 8 weeks ]
    Will be descriptive.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Thomas Jefferson University

Dates:
Date Received: August 5, 2012
Date Started: August 2012
Date Completion:
Last Updated: October 19, 2016
Last Verified: October 2016