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

This study has been withdrawn prior to enrollment.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01660347
First Posted: August 8, 2012
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
  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: Intervention Model: Single Group Assignment
Masking: None (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 ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):

Primary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: August 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660347


Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
Principal Investigator: Dolores Grosso, DNP, CRNP Thomas Jefferson University
  More Information

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01660347     History of Changes
Other Study ID Numbers: 12D.214
2012-35 ( Other Identifier: CCRRC )
First Submitted: August 5, 2012
First Posted: August 8, 2012
Last Update Posted: October 21, 2016
Last Verified: October 2016

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