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Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies (LYMPHCORD)

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ClinicalTrials.gov Identifier: NCT01966510
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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%. 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.


Condition or disease Intervention/treatment Phase
Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor Other: Cord Blood Transplantation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.
Study Start Date : March 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: 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.
Other: Cord Blood Transplantation



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Engraftment [ Time Frame: 100 days ]
    Neutrophils > 500/mm3 and platelets > 20 Giga/L

  2. Chimerism [ Time Frame: D15, D30, D60, D100, M6, M12 and M24 ]
    using PCR

  3. Acute Graft versus host disease (GvHD) [ Time Frame: 100 days ]
  4. Chronic graft versus host disease (GVHD) [ Time Frame: within 2 years after inclusion ]
  5. Immunologic reconstitution [ Time Frame: D30, D60, D100, M6, M12 and M24 ]
    phenotypic measurements of lymphocyrtes populations (T, B and NK)

  6. Incidence of severe infectious complications [ Time Frame: D100 and M12 ]
    defined using criteria from EBMT (Cordonnier, www.ebmt.org)

  7. Relapse rate [ Time Frame: within the 2 years after inclusion ]
  8. Relapse free survival [ Time Frame: 2 years ]
  9. toxicity [ Time Frame: 2 years ]
    recorded according to OMS grading scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18-65 years old
  • 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:

  • No patient signed consent
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966510


Locations
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France
Saint Louis hospital
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01966510     History of Changes
Other Study ID Numbers: P110145
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
cord blood transplant
advanced lymphoid malignancies

Additional relevant MeSH terms:
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Neoplasms