One cord blood unit may replace two in stem cell transplants for blood cancer
NCT ID NCT01034449
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new way to treat blood cancers like leukemia in 16 adults who did not have a standard bone marrow donor. Doctors used a single unit of cord blood that was grown in a lab to increase the number of stem cells before transplant. The goal was to see if this method could safely control the cancer and help the body rebuild healthy blood cells, while also being more affordable and saving cord blood resources.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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16 people
The number who actually took part.
- Start date
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Feb 2010
- Finished
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Sep 2014
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 and \< 66 years * Patient with acute myeloid leukemia (AML) high risk in 1st complete remission: * CR1 obtained by 2 cycles of chemotherapy, * unfavorable Cytogenetics * FLT3 Duplication, * Or acute myeloid leukemia (AML) in 2nd complete remission, * Or acute lymphoblastic leukemia (ALL) High-risk 1st complete remission: * Presence of the translocation t (9; 22), * Or acute lymphoblastic leukemia (ALL) in 2nd complete remission, * Or Chronic Myeloid Leukemia (LCM) beyond the 1st chronic phase * Or Myelodysplasia or with IPSS score with 2 or more * Or Hodgkin's disease in sensitive relapse or beyond the 2nd complete remission. or following types of lymphoma : * Diffuse large B lymphoma cells relapsed or refractory after two lines of treatment or after a line with autologous hematopoietic stem cell, or * Mantle cell lymphoma relapsed or refractory after two lines of treatment or after a line with autologous hematopoietic stem cell * Others aggressive lymphoma for which an indication of allograft is selected (Burkitt lymphoma, lymphoblastic lymphoma, intravascular lymphoma, ...) * Lymphoma (low-grade follicular lymphoma, marginal zone lymphoma) in histological transformation. * Low-grade lymphoma for which an indication of allograft is retained * Unable to receive myeloablative conditioning because of age (\> 45 years) and/or the existence of co-morbidities precluding a myeloablative conditioning (status ECOG \> / = 2, DLCO \<50%, fungal infection proven or probable in the previous 60 days) and / or prior treatment with total body irradiation at doses above 2 Gy or busulfan doses\> 8 mg/kg * No contra-indication for a transplant in allogeneic non-myeloablative conditioning, * No HLA-identical sibling, * Absence of an unrelated donor on national or international registering with a 10/10 allelic matching or a 9/10 allelic matching with the only tolerated mismatches being: HLA-C. * No unit of placental blood available fulfilling the characteristics of compatibility (HLA compatible at least 4/6 allele or generic) and richness * Provision of at least 2 units of placental blood, whose compatibility is 4/6, 5/6 or 6/6 and whose richness is before thawing, \> 2 x 107 and \< 3 to 4 x 107 nucleated cells per/kg. * Patient affiliated to a social security scheme, * Free and informed consent signed by the patient and the investigator. Exclusion Criteria: * Age \<18 and ≥ 66 years * Malignant myeloid or lymphoid acute or chronic disease without indication for an allogeneic transplant according to the criteria of European Bone Marrow Transplantation Group. * Able to receive a myeloablative conditioning because of age (\<45 years) and the absence of co morbidities (status ECOG\> / = 2, DLCO \<50%, fungal infection proven or probable in 60 preceding days) and the absence of prior treatment with total body irradiation at doses above 2 Gy or busulfan doses\> 8 mg / kg * Contra indication for a non-myeloablative conditioning, * HLA-identical sibling available * Availability of an unrelated donor on a national or international register with 10/10 or 9/10 HLA matching (HLA-C Mismatch tolerated). * At least one unit of cord blood available with the characteristics of compatibility (HLA compatible at least 4/6 allelic or generic) and richness (before thawing\> / = 3 to 4 x 107 nucleated cells/kg recipient, by degree of compatibility) * Absence of at least 2 units of placental blood, whose compatibility is 4/6, 5/6 / or 6/6 and whose richness before thawing is \> 2 x 107 and \< 4 x 107 nucleated cells per/kg of recipient. * Women of childbearing age not using contraception, pregnant or lactating
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Service d'Hématologie, Hôpital Hôtel Dieu, CHU de Nantes - 1 Place Alexis Ricordeau
Nantes, 44093, France
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Service d'hématologie et d'Oncologie Clinique - Hôpital Lapeyronie - 371 avenue du Doyen Gaston GIRAUD
Montpellier, 34295, France
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Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan
Pessac, 33600, France
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Other studies related to the condition(s) this trial covers.
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