Hematologic MalignancyNCT02049424
Observational Study in Patients Who Underwent an Haploidentical Transplantation With T-repleted Bone Marrow
An observational study of Hematologic Malignancy, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Outcome evaluation in patients who underwent transplantation with T-repleted bone marrow after post-transplantation cyclophosphamide Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2011to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent a haploidentical transplantion after non-myeloablative conditioning regimen
Who may be able to join
- patients affected by hematologic neoplasia who underwent a haploidentical transplantation (2-3 mismatches) from a familiar donor, with non-ex vivo manipulated bone marrow and post-transplantation cyclophosphamide
Who cannot join
- ex vivo manipulated bone marrow transplantation
- use of antilymphocyte serum during conditioning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective-prospective Observational Study for Data Collection of Patients Who Underwent an Haploidentical Transplantation After Non-myeloablative Conditioning Regimen
Outcome evaluation in patients who underwent transplantation with T-repleted bone marrow after post-transplantation cyclophosphamide
Read the detailed description
Patients who underwent transplantation with T-repleted bone marrow haploidentical transplantation will be analyzed considering toxicity incidence (GVHD, infective complications, graft-failure incidence and TRM)and efficacy variables (Overall Survival, Progression Free Survival and Relapse incidence)
- Conditions
- Hematologic Malignancy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| transplanted patients | T-repleted haploidentical transplanted patients in Italy |
What is being measured
The primary outcome is the main question the study is designed to answer.
toxicity evaluation
Chronic and acute GVHD, infectious complications, graft failure, TRM
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startMar 2011
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Castagna, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049424
- Sponsor's protocol ID
- ONC/OSS-03/2011
- Status last verified
- Jan 2014
- First submitted
- 28 Jun 2013
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Roberto A, Castagna L, Zanon V, Bramanti S, Crocchiolo R, McLaren JE, Gandolfi S, Tentorio P, Sarina B, Timofeeva I, Santoro A, Carlo-Stella C, Bruno B, Carniti C, Corradini P, Gostick E, Ladell K, Price DA, Roederer M, Mavilio D, Lugli E. Role of naive-derived T memory stem cells in T-cell reconstitution following allogeneic transplantation. Blood. 2015 Apr 30;125(18):2855-64. doi: 10.1182/blood-2014-11-608406. Epub 2015 Mar 5.
PubMed 25742699Roberto A, Castagna L, Gandolfi S, Zanon V, Bramanti S, Sarina B, Crocchiolo R, Todisco E, Carlo-Stella C, Tentorio P, Timofeeva I, Santoro A, Della Bella S, Roederer M, Mavilio D, Lugli E. B-cell reconstitution recapitulates B-cell lymphopoiesis following haploidentical BM transplantation and post-transplant CY. Bone Marrow Transplant. 2015 Feb;50(2):317-9. doi: 10.1038/bmt.2014.266. Epub 2014 Nov 24. No abstract available.
PubMed 25419693
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective-prospective Observational Study for Data Collection of Patients Who Underwent an Haploidentical Transplantation After Non-myeloablative Conditioning Regimen
- ClinicalTrials.gov ID
- NCT02049424
- Acronym / sponsor ID
- ONC/OSS-03/2011
- Conditions
- Hematologic Malignancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 Jan 2014 (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.
Outcome evaluation in patients who underwent transplantation with T-repleted bone marrow after post-transplantation cyclophosphamide
Detailed description
Patients who underwent transplantation with T-repleted bone marrow haploidentical transplantation will be analyzed considering toxicity incidence (GVHD, infective complications, graft-failure incidence and TRM)and efficacy variables (Overall Survival, Progression Free Survival and Relapse incidence)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transplanted patients | – | –T-repleted haploidentical transplanted patients in Italy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent a haploidentical transplantion after non-myeloablative conditioning regimen
Key inclusion criteria (1 listed)
- patients affected by hematologic neoplasia who underwent a haploidentical transplantation (2-3 mismatches) from a familiar donor, with non-ex vivo manipulated bone marrow and post-transplantation cyclophosphamide
Key exclusion criteria (2 listed)
- ex vivo manipulated bone marrow transplantation
- use of antilymphocyte serum during conditioning
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
toxicity evaluation
Time frame: 1 year
Chronic and acute GVHD, infectious complications, graft failure, TRM
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Derived from this study: PubMed 25742699Roberto A, Castagna L, Zanon V, Bramanti S, Crocchiolo R, McLaren JE, Gandolfi S, Tentorio P, Sarina B, Timofeeva I, Santoro A, Carlo-Stella C, Bruno B, Carniti C, Corradini P, Gostick E, Ladell K, Price DA, Roederer M, Mavilio D, Lugli E. Role of naive-derived T memory stem cells in T-cell reconstitution following allogeneic transplantation. Blood. 2015 Apr 30;125(18):2855-64. doi: 10.1182/blood-2014-11-608406. Epub 2015 Mar 5.
- Derived from this study: PubMed 25419693Roberto A, Castagna L, Gandolfi S, Zanon V, Bramanti S, Sarina B, Crocchiolo R, Todisco E, Carlo-Stella C, Tentorio P, Timofeeva I, Santoro A, Della Bella S, Roederer M, Mavilio D, Lugli E. B-cell reconstitution recapitulates B-cell lymphopoiesis following haploidentical BM transplantation and post-transplant CY. Bone Marrow Transplant. 2015 Feb;50(2):317-9. doi: 10.1038/bmt.2014.266. Epub 2014 Nov 24. No abstract available.
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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.
Luca Castagna, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy, run by Istituto Clinico Humanitas at 1 site in Italy.
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 2 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: stopped early, as of the sponsor's last update on 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
toxicity evaluation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02049424, which also lists 2 linked publications.
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 30 Jan 2014.