Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies
NCT ID: NCT01966510
Last Updated: 2017-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2013-03-31
2017-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cord blood transplantation
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.
Cord Blood Transplantation
Interventions
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Cord Blood Transplantation
Eligibility Criteria
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Inclusion Criteria
* no sibling or unrelated donor identified (9/10 or 10/10)
* with either one of these advanced lymphoid malignancies
1. low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation)
2. hodgkin lymphoma in early relapse (\<1 year)who received at least one autologous transplantation and sensible to chemotherapy
3. CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation.
Exclusion Criteria
* Previous allograft
* Psychiatric conditions
* HIV positive
* HVC hepatitis requiring treatment
* Previous total body irradiation (TBI)
* Any contraindication to TBI
* Any contraindication to allograft, such as cardiovascular, respiratory, renla or liver dysfunctions
* No Health care insurance
18 Years
65 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Saint Louis hospital
Paris, , France
Countries
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Other Identifiers
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P110145
Identifier Type: -
Identifier Source: org_study_id