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OpenTrials
Completed

NCT Number: NCT01966510

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saint Louis hospital

Paris, 75010, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

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

Treatment and study plan

Cord Blood Transplantation

Other

Primary outcomes

  1. Overall survival

    Time frame: 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.

Acronym: LYMPHCORD

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Oct 21, 2013
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.