Allo After Allo Stem Cell Transplantation Following Relapse After Allogeneic Transplant in Haematological Malignancies: Retrospective Results of the GETH

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Grupo Espanol de trasplantes hematopoyeticos y terapia celular.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
ClinicalTrials.gov Identifier:
NCT01212796
First received: September 30, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition
Allogeneic Stem Cell Transplantation

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Second and Further Allogeneic Stem Cell Transplantation Following Relapse After Allogeneic Transplant in Haematological Malignancies: Retrospective Results of the GETH

Resource links provided by NLM:


Further study details as provided by Grupo Espanol de trasplantes hematopoyeticos y terapia celular:

Estimated Enrollment: 350
Study Start Date: September 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:

It reviewed 350 patients who underwent allogeneic 2 or more between the beginning of monitoring and the end of 2009, end of follow-up. Is a multicenter study of row should include all possible patients who take the appropriate data. To all centers contributing patients to the study, were asked to fill out basic information related to the data sheets of the EBMT report (MED-A and MED-B).

To collect these forms of EBMT, patients have previously authorized through the informed consent of this information collection.

It will include basic descriptive characteristics of the cohort and comparisons between groups were conducted to check if the sample is homogeneous.

The analysis is divided into descriptive data collection related to the transplant, both prior to transplantation and on during it. It also collected data related to transplant once done this.

FINDINGS AND PURPOSE The main variables to be analyzed are: overall survival, disease-free survival and progression, relapse rate and transplant-related mortality.

Secondary endpoints to be analyzed can vary once made the data collection. Yet between them will include: incidence of graft-versus-host disease (both acute and chronic), incidence of infections.

The purpose of this study is the description of variables that can predict the success or failure of making a second allogeneic transplant after the first relapse. These variables were also analyzed for third or subsequent transplants.

Also seeks to differentiate risk groups among patients. The novelty of this study could provide regarding previously published studies is the description of third or subsequent transplants, so far there are few references to this in the literature to date.

FINANCING This study does not require funding.

CONFLICT OF INTEREST There is no conflict of interest

DATA COLLECTION PERIOD AEMET submission and acceptance: 1-2 months. Aceppt (SEPT-10-2010) Data collection: 3 - 6 months Results: at 6 - 9 months Publication and presentation at conferences, at 12 months

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  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: NCT01212796

Contacts
Contact: Duarte R Palomino, MD 34 666458025 rduarte@iconcologia.net
Contact: Orti G Pascual, Data Manager gorti@iconcologia.net

Sponsors and Collaborators
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Investigators
Principal Investigator: Duarte R Palomino, MD Grupo Espanol de trasplantes hematopoyeticos y terapia celular
  More Information

No publications provided

Responsible Party: Angel Cedillo, GETH
ClinicalTrials.gov Identifier: NCT01212796     History of Changes
Other Study ID Numbers: GET-ALO-2010-01, get-alo-2010-01
Study First Received: September 30, 2010
Last Updated: September 30, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Grupo Espanol de trasplantes hematopoyeticos y terapia celular:
allogeneic stem cell transplantation

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014