NCT01660347

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 2, 2025

Status Verified

May 1, 2025

Enrollment Period

2.3 years

First QC Date

August 5, 2012

Last Update Submit

May 1, 2025

Conditions

AnemiaHematopoietic/Lymphoid CancerLymphopeniaNeutropeniaThrombocytopenia

Outcome Measures

Primary Outcomes (6)

  • Etiologies of post HSCT cytopenias

    Will be collected and reported descriptively.

    Up to 8 weeks

  • CD34+/kg and CD3+/kg cell doses in the infused CD 34+ selected boost products

    Will be collected and reported descriptively.

    Up to 8 weeks

  • Effects of the CD 34+ selected boost on peripheral blood cell counts

    Will be collected and reported descriptively.

    Up to 8 weeks

  • Incidence of GVHD related to the CD34+ selected boost

    Will be collected and reported descriptively.

    Up to 8 weeks

  • 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

    Will be descriptive.

    Up to 8 weeks

  • Incidence of severe GVHD (grades 3-4), graded according to standard criteria

    Will be descriptive.

    Up to 8 weeks

Study Arms (1)

Supportive care (allogeneic PBSCT boost)

EXPERIMENTAL

Patients undergo allogeneic PBSCT boost from cells selected for CD34+ using the CliniMACS CD34 Reagent System.

Biological: Allogeneic hematopoietic stem cell transplantationBiological: Peripheral blood stem cell transplantationProcedure: Management of therapy complications

Interventions

Allogeneic hematopoietic stem cell transplantationBIOLOGICAL

Undergo allogeneic PBSCT boost using the CliniMACS CD34 Reagent System

Supportive care (allogeneic PBSCT boost)
Peripheral blood stem cell transplantationBIOLOGICAL

Undergo allogeneic PBSCT boost using the CliniMACS CD34 Reagent System

Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Supportive care (allogeneic PBSCT boost)
Management of therapy complicationsPROCEDURE

Undergo allogeneic PBSCT boost using the CliniMACS CD34 Reagent System

Supportive care (allogeneic PBSCT boost)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No evidence of active disease as measured by staging studies pertinent to the particular diagnosis within 1 month of the CD 34+ boost
  • 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.
  • 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
  • ANC of \< 1000 10\^6/L or maintenance of an ANC ≥ 1000 10\^6/L only with white cell growth factor support
  • Requirement for red cell transfusion to maintain a hemoglobin of ≥ 9.0 g/dL
  • Requirement for red cell transfusion to avoid symptomatic anemia in patients with hemoglobin values of ≤ 11.0 g/dL
  • Requirement for platelet transfusion to maintain a platelet count of ≥ 20 10\^9/L
  • Requirement for platelet transfusion to avoid bleeding in patients with platelet counts ≤ 50 109/L
  • No signs of active acute GVHD (excluding stages I-II skin GVHD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

AnemiaHematologic NeoplasmsLymphopeniaNeutropeniaThrombocytopenia

Interventions

Peripheral Blood Stem Cell TransplantationTransplantation

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsLeukopeniaCytopeniaLeukocyte DisordersImmunologic Deficiency SyndromesImmune System DiseasesAgranulocytosisBlood Platelet Disorders

Intervention Hierarchy (Ancestors)

Hematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Dolores Grosso, DNP, CRNP

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2012

First Posted

August 8, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 2, 2025

Record last verified: 2025-05