LymphomaNCT01891578
Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation
An observational study of Lymphoma, run by Armando Santoro, MD at 1 site in Italy.
Trial summary
Evaluation of immunological reconstitution after haploidentical BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Dec 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 with lymphoma (any histology)
Who may be able to join
- Patients with lymphoma (any histology) relapsed after high dose chemotherapy and in partial remission, complete remission or stable disease after the last CT line that
- Signed informed consent to perform an haploidentical allo-BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation Using a Nonmyeloablative Preparative Regimen and Post-transplant Cyclophosphamide, in Patients With Poor Prognosis Lymphomas
Evaluation of immunological reconstitution after haploidentical BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis lymphoma
- Conditions
- Lymphoma
- Medical subject headings
- Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of T lymphocytes and NK cells absolute number
Measured: 1 year
Secondary outcomes (4)
Evaluation of discrete T-cells populations
Evaluation, by flow cytometry, of discrete T cell populations, including CD4+ and CD8+ TN, TSCM, TCM and TEM, NK and NKT cells, B cells, dendritic cell subsets
Measured: 1 year
Evaluation of antigen-specific T cell populations
Evaluation of antigen-specific T cell frequency towards CMV, EBV and influenza virus by MHC tetramers
Measured: 1 year
Evaluation of antigen-specific T lymphocyte's functionality
antigen-specific T lymphocyte's functionality towards tumor cell line evaluated using a degranulation assay
Measured: 1 year
Evaluation of cytokines production by IL-2 and anti-CD16 activated NK cells
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 posted3 Jul 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armando Santoro, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armando Santoro, MD, Istituto Clinico Humanitas
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891578
- Sponsor's protocol ID
- ONC/OSS-04/2010
- Status last verified
- Jun 2013
- First submitted
- 27 May 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation Using a Nonmyeloablative Preparative Regimen and Post-transplant Cyclophosphamide, in Patients With Poor Prognosis Lymphomas
- ClinicalTrials.gov ID
- NCT01891578
- Acronym / sponsor ID
- ONC/OSS-04/2010
- Conditions
- Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Armando Santoro, MDUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 3 Jul 2013 (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.
Evaluation of immunological reconstitution after haploidentical BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis lymphoma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lymphoma (any histology)
Key inclusion criteria (2 listed)
- Patients with lymphoma (any histology) relapsed after high dose chemotherapy and in partial remission, complete remission or stable disease after the last CT line that
- Signed informed consent to perform an haploidentical allo-BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide
Key exclusion criteria (1 listed)
- none
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
Evaluation of T lymphocytes and NK cells absolute number
Time frame: 1 year
4 secondary outcomes
Evaluation of discrete T-cells populations
Time frame: 1 year
Evaluation of antigen-specific T cell populations
Time frame: 1 year
Evaluation of antigen-specific T lymphocyte's functionality
Time frame: 1 year
Evaluation of cytokines production by IL-2 and anti-CD16 activated NK cells
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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.
Armando Santoro, 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 Lymphoma, run by Armando Santoro, MD 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 2 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 3 Jul 2013. 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?
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?
Evaluation of T lymphocytes and NK cells absolute number (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 3 Jul 2013.