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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01660347
First received: August 5, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Anemia
Hematopoietic/Lymphoid Cancer
Lymphopenia
Neutropenia
Thrombocytopenia
Biological: Allogeneic hematopoietic stem cell transplantation
Biological: Peripheral blood stem cell transplantation
Procedure: Management of therapy complications

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Etiologies of post HSCT cytopenias [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Will be collected and reported descriptively.

  • Effects of the CD 34+ selected boost on peripheral blood cell counts [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    Will be collected and reported descriptively.

  • Incidence of GVHD related to the CD34+ selected boost [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Will be descriptive.

  • Incidence of severe GVHD (grades 3-4), graded according to standard criteria [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
    Will be descriptive.


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (allogeneic PBSCT boost)
Patients undergo allogeneic PBSCT boost from cells selected for CD34+ using the CliniMACS CD34 Reagent System.
Biological: Allogeneic hematopoietic stem cell transplantation
Undergo allogeneic PBSCT boost using the CliniMACS CD34 Reagent System
Biological: Peripheral blood stem cell transplantation
Undergo allogeneic PBSCT boost using the CliniMACS CD34 Reagent System
Other Names:
  • PBPC transplantation
  • PBSC transplantation
  • peripheral blood progenitor cell transplantation
  • transplantation
  • peripheral blood stem cell
Procedure: Management of therapy complications
Undergo allogeneic PBSCT boost using the CliniMACS CD34 Reagent System

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. No evidence of active disease as measured by staging studies pertinent to the particular diagnosis within 1 month of the CD 34+ boost
  2. Full donor chimerism as manifested by a ≥ 90% donor peripheral blood total, MNC, and T cell chimerism result on the last two studies prior to the planned CD 34+ boost, with the second study performed within 1 month of the infusion.
  3. HHV-6 and CMV negative by PCR for at least 1 month prior to the CD 34+ boost as measured by at least 2 assays within the month timeframe
  4. ANC of < 1000 10^6/L or maintenance of an ANC ≥ 1000 10^6/L only with white cell growth factor support
  5. Requirement for red cell transfusion to maintain a hemoglobin of ≥ 9.0 g/dL
  6. Requirement for red cell transfusion to avoid symptomatic anemia in patients with hemoglobin values of ≤ 11.0 g/dL
  7. Requirement for platelet transfusion to maintain a platelet count of ≥ 20 10^9/L
  8. Requirement for platelet transfusion to avoid bleeding in patients with platelet counts ≤ 50 109/L
  9. No signs of active acute GVHD (excluding stages I-II skin GVHD)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660347

Contacts
Contact: Dolores Grosso, DNP, CRNP 215-955-8874
Contact: Donna Zuccarello 215-955-6612

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Dolores Grosso, DNP, CRNP    215-955-8874      
Contact: Donna Zuccarello    2012-955-6612      
Principal Investigator: Dolores Grosso, DNP, CRNP         
Sub-Investigator: Neal Flomenberg, MD         
Sub-Investigator: S. Onder Alpdogan, MD         
Sub-Investigator: Matthew Carabasi, MD         
Sub-Investigator: Joanne Filicko-O'Hara, MD         
Sub-Investigator: Margaret Kasner, MD         
Sub-Investigator: Ubaldo Outschoorn Martinez, MD         
Sub-Investigator: John Wagner, MD         
Sub-Investigator: Mark Weiss, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Dolores Grosso, DNP, CRNP Thomas Jefferson University
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01660347     History of Changes
Other Study ID Numbers: 12D.214, 2012-35
Study First Received: August 5, 2012
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphopenia
Neutropenia
Thrombocytopenia
Agranulocytosis
Blood Platelet Disorders
Hematologic Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Leukocyte Disorders
Leukopenia

ClinicalTrials.gov processed this record on November 25, 2014