NCT01212796

Brief Summary

The allogeneic hematopoietic stem cell marrow is the only curative treatment for many hematologic malignancies. However, many patients relapse in these situations to be therapeutic possibilities scarce and mixed. Chemotherapy in these situations does not show good results and new drugs have not yet demonstrated the effectiveness desired. Another therapeutic approach after relapse post allogeneic transplant is to resubmit the allogeneic transplant patient to patient. In this clinical situation is little known. All previous studies are retrospective, the data provided are of little statistical value and heterogeneous patient samples. The GETH (Grupo Espanol de trasplantes hematopoyeticos y terapia celular) has included in its database a figure around 350 seconds allogeneic transplants. Comparing this with the studies published so far, this would be the largest retrospective series published size compared to second allogeneic transplants.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

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

September 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 1, 2010

Status Verified

September 1, 2010

Enrollment Period

6 months

First QC Date

September 30, 2010

Last Update Submit

September 30, 2010

Conditions

Keywords

allogeneic stem cell transplantation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent 2 or more allogeneic transplants in Spanish hospitals between the beginning of monitoring and the end of 2009, end of follow-up.

You may qualify if:

  • patients who underwent 2 or more allogeneic transplants and the beginning of monitoring and the end of 2009, end of follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Duarte R Palomino, MD

    Grupo Espanol de trasplantes hematopoyeticos y terapia celular

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Duarte R Palomino, MD

CONTACT

Orti G Pascual, Data Manager

CONTACT

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 1, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

October 1, 2010

Record last verified: 2010-09