Allogeneic Stem Cell TransplantationNCT01212796
Allo After Allo Stem Cell Transplantation Following Relapse After Allogeneic Transplant in Haematological Malignancies: Retrospective Results of the GETH
An observational study of Allogeneic Stem Cell Transplantation, run by Grupo Espanol de trasplantes hematopoyeticos y terapia celular.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Allogeneic Stem Cell Transplantation
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- patients who underwent 2 or more allogeneic transplants and the beginning of monitoring and the end of 2009, end of follow-up.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
Orti G Pascual, Data Manager contact
About this study
Official title: Second and Further Allogeneic Stem Cell Transplantation Following Relapse After Allogeneic Transplant in Haematological Malignancies: Retrospective Results of the GETH
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.
Read the 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
- Conditions
- Allogeneic Stem Cell Transplantation
- Keywords
- allogeneic stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celular
- Sponsor type
- University, hospital or other
- Investigators
- Duarte R Palomino, MD, Principal investigator, Grupo Espanol de trasplantes hematopoyeticos y terapia celular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212796
- Sponsor's protocol ID
- GET-ALO-2010-01
- Other IDs
- get-alo-2010-01
- Status last verified
- Sep 2010
- First submitted
- 30 Sep 2010
- Last updated
- 1 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second and Further Allogeneic Stem Cell Transplantation Following Relapse After Allogeneic Transplant in Haematological Malignancies: Retrospective Results of the GETH
- ClinicalTrials.gov ID
- NCT01212796
- Acronym / sponsor ID
- GET-ALO-2010-01
- Conditions
- Allogeneic Stem Cell Transplantation
- Keywords
- allogeneic stem cell transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celularUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients who underwent 2 or more allogeneic transplants and the beginning of monitoring and the end of 2009, end of follow-up.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orti G Pascual, Data Manager contact
Duarte R Palomino, MD principal investigator
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Stem Cell Transplantation, run by Grupo Espanol de trasplantes hematopoyeticos y terapia celular.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duarte R Palomino, MD (34 666458025, rduarte@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2010.