NCT01555359

Brief Summary

Autologous hematopoietic cell transplantation (HCT) is a treatment strategy used as advanced line therapy for different malignancies, mainly hematological. Its main advantage lies in the ability to provide hematologic and immune rescue after high dose chemotherapy therapy. The first requirement of a successful transplantation is recruitment of sufficient amount of cells. This is achieved by mobilizing CD34+ stem cells from the bone marrow to the peripheral blood, by G-CSF priming, and then harvesting the cells from the peripheral blood at the right timing by means of apheresis. Currently, the decision on the optimal collection timing is based on the pre-collection CD34 cells blood concentrations. The investigators goal is to investigate whether telomerase, the telomere elongation enzyme, which constitutionally and solely expressed in progenitor cells, is correlated with collection and post HCT engraftment characteristics. The investigators will collect blood from patients when starting GCSF and on the day of planned apheresis. Pearson correlation test will be used to correlate between telomerase activity in the samples and with collection and engraftment characteristics.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 15, 2012

Status Verified

January 1, 2012

First QC Date

March 13, 2012

Last Update Submit

March 14, 2012

Conditions

Study Arms (1)

Patients undergoing stem cell collection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing stem cell mobilization and collection

You may qualify if:

  • Age \>18 years
  • Patient is candidate for stem cell mobilization and collection
  • Patient is willing to sign an informed concent

You may not qualify if:

  • Age \<18 years
  • Patient not willing or not in a state to sign an informed concent
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMT Unit, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital

Petah Tikva, 49100, Israel

RECRUITING

Related Publications (1)

  • Szyper-Kravitz M, Uziel O, Shapiro H, Radnay J, Katz T, Rowe JM, Lishner M, Lahav M. Granulocyte colony-stimulating factor administration upregulates telomerase activity in CD34+ haematopoietic cells and may prevent telomere attrition after chemotherapy. Br J Haematol. 2003 Jan;120(2):329-36. doi: 10.1046/j.1365-2141.2003.04043.x.

    PMID: 12542495BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

LymphomaMultiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Study Officials

  • Ron Ram, M.D.

    BMT Unit, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ron Ram, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 15, 2012

Study Start

February 1, 2012

Study Completion

February 1, 2013

Last Updated

March 15, 2012

Record last verified: 2012-01

Locations