Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch DonorPhase 2LYMPHCORDNCT01966510
Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies
A Phase 2 study testing Cord Blood Transplantation in people with Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical or mismatch donor. Objectives: Overall survival at one year. Efficacy >60%, rejection rate <20%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor
- What is being tested?
- Cord Blood Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Dec 2017
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years old
- no sibling or unrelated donor identified (9/10 or 10/10)
- with either one of these advanced lymphoid malignancies
- low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation)
- hodgkin lymphoma in early relapse (<1 year)who received at least one autologous transplantation and sensible to chemotherapy
- CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation.
Who cannot join
- No patient signed consent
- Previous allograft
- Psychiatric conditions
- HIV positive
- HVC hepatitis requiring treatment
- Previous total body irradiation (TBI)
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- Any contraindication to TBI
- Any contraindication to allograft, such as cardiovascular, respiratory, renla or liver dysfunctions
- No Health care insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.
Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical or mismatch donor.
Objectives: Overall survival at one year. Efficacy >60%, rejection rate <20%. Inclusion criteria: Age: 18-65 years old, no sibling or unrelated donor identified, low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation); hodgkin lymphoma in early relapse (<1 year), who received at least one autologous transplantation and sensible to chemotherapy and CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation.
Stem cell source: Two cord blood units containing both together more than 3x107 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients.
- Conditions
- Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor
- Being tested
- Cord Blood Transplantation
- Keywords
- cord blood transplant, advanced lymphoid malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord Blood TransplantationOther
| Study group | Role | What they receive |
|---|---|---|
| Cord blood transplantation | Experimental | Two cord blood units containing both together more than 3x10^7 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients. Receives: Other: Cord Blood Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 1 year
Secondary outcomes (9)
Engraftment
Neutrophils > 500/mm3 and platelets > 20 Giga/L
Measured: 100 days
Chimerism
using PCR
Measured: D15, D30, D60, D100, M6, M12 and M24
Acute Graft versus host disease (GvHD)
Measured: 100 days
Chronic graft versus host disease (GVHD)
Measured: within 2 years after inclusion
Immunologic reconstitution
phenotypic measurements of lymphocyrtes populations (T, B and NK)
Measured: D30, D60, D100, M6, M12 and M24
Incidence of severe infectious complications
defined using criteria from EBMT (Cordonnier, www.ebmt.org)
Measured: D100 and M12
Relapse rate
Measured: within the 2 years after inclusion
Relapse free survival
Measured: 2 years
toxicity
recorded according to OMS grading scale
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch DonorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966510
- Sponsor's protocol ID
- P110145
- Acronym
- LYMPHCORD
- Status last verified
- Dec 2017
- First submitted
- 17 Oct 2013
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.
- ClinicalTrials.gov ID
- NCT01966510
- Acronym / sponsor ID
- LYMPHCORD / P110145
- Conditions
- Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor
- Keywords
- cord blood transplant, advanced lymphoid malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Oct 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.
Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical or mismatch donor.
Objectives: Overall survival at one year. Efficacy >60%, rejection rate <20%. Inclusion criteria: Age: 18-65 years old, no sibling or unrelated donor identified, low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation); hodgkin lymphoma in early relapse (<1 year), who received at least one autologous transplantation and sensible to chemotherapy and CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation.
Stem cell source: Two cord blood units containing both together more than 3x107 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cord blood transplantation | Experimental | Other: Cord Blood TransplantationTwo cord blood units containing both together more than 3x10^7 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-65 years old
- no sibling or unrelated donor identified (9/10 or 10/10)
- with either one of these advanced lymphoid malignancies
Key exclusion criteria (9 listed)
- No patient signed consent
- Previous allograft
- Psychiatric conditions
- HIV positive
- HVC hepatitis requiring treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cord Blood Transplantation | Other | Cord blood transplantation |
Primary outcome
Overall survival
Time frame: 1 year
9 secondary outcomes
Engraftment
Time frame: 100 days
Chimerism
Time frame: D15, D30, D60, D100, M6, M12 and M24
Acute Graft versus host disease (GvHD)
Time frame: 100 days
Chronic graft versus host disease (GVHD)
Time frame: within 2 years after inclusion
Immunologic reconstitution
Time frame: D30, D60, D100, M6, M12 and M24
Incidence of severe infectious complications
Time frame: D100 and M12
Relapse rate
Time frame: within the 2 years after inclusion
Relapse free survival
Time frame: 2 years
toxicity
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cord Blood Transplantation in people with Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 8 Dec 2017. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (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 8 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.