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Malignant Haematological DiseasePhase 2GRAPANCT01034449

Transplantation of Ex-vivo Expanded Cord Blood Stems Cells

A Phase 2 study testing allogeneic transplant in people with Malignant Haematological Disease, run by University Hospital, Bordeaux at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This program offers the opportunity to receive an allogeneic transplant to try to control the malignant hematologic in the absence of acceptable conventional donor and with a risk-benefit ratio equivalent to that which would be expected with a transplant from a more conventional donor. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Malignant Haematological Disease
What is being tested?
allogeneic transplant
How many people
16 participants
Where
3 sitesFrance
Study dates
Feb 2010to Sep 2014
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 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,
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  • 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.

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Service d'hématologie et d'Oncologie Clinique - Hôpital Lapeyronie - 371 avenue du Doyen Gaston GIRAUD

    Montpellier, 34295

  • Service d'Hématologie, Hôpital Hôtel Dieu, CHU de Nantes - 1 Place Alexis Ricordeau

    Nantes, 44093

  • Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan

    Pessac, 33600

Other trials in France

About this study

Official title: Transplantation of Ex-vivo Expanded Human Cord Blood Hematopoietic Stem Cells Expanded: Evaluation of Hematopoietic and Immunologic Reconstitution After a Reduced-intensity Conditioning Regimen

This program offers the opportunity to receive an allogeneic transplant to try to control the malignant hematologic in the absence of acceptable conventional donor and with a risk-benefit ratio equivalent to that which would be expected with a transplant from a more conventional donor.

An economy of means in that this method could serve as an alternative to 2 units of placental blood transplantation. The current cost of disposal of a unit of placental blood from a bank is approximately 22000 € (Source: Biomedicine Agency, 2007 rates). The amplification process as controlled by "EFSAL" is 12000 €. Therefore, buying a unit and ex-vivo amplification is more economical. Moreover, the availability of placental blood is not infinite, and the use of one unit per patient will also save resources that can be valuable for certain groups of patients.

In the longer term, methods of amplification of specific immunocompetent cells (from the fraction of CD 34 neg cells) are already being evaluated in the laboratory. They allow to consider a faster recovery, better and more targeted, including cells against the disease for which transplantation is performed.

Read the detailed description

This is a multicenter prospective non randomized phase 2 clinical trial.

The primary objective is defined by getting a neutrophil count above 500/ml for 3 consecutive days at day 42 after transplantation, in association with complete or partial chimerism on T cells (10 % to 90%).

The secondary objectives are:

  • the feasibility of expansion,
  • tolerance immediate injection of a graft amplified,
  • the payback of a platelet count> 20 000/microlitre without transfusion,
  • Incidence of graft loss or rejection within 6 months following transplantation,
  • the incidence of acute and chronic GVHD,
  • the mortality rate associated with transplantation,
  • the incidence of relapse of hematologic malignancies,
  • Overall survival,
  • Disease-free survival at 1 year post transplant.
Being tested
allogeneic transplant
Keywords
allo graft, cord blood, expansion, reduced-intensity conditioning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • allogeneic transplantOther

    ex vivo amplification of a unit of placental blood for transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of granulocytes, which will be evaluated daily after transplantation. And chimerism to be measured on the cells (total nucleated cells and lymphocytes) from peripheral blood on days 15, 42, 60, 100, 180, 360.

    Measured: Daily for Blood évaluation and on days 15-42-60-100-180-360 for chimérisme évaluation.

Secondary outcomes (11)

  1. feasibility of expansion

    Measured: during and after expansion

  2. Immediate tolerance of a graft amplified injection. Determined by measurement of vital parameters during injection of the graft and within 3 hours of observation and clinical tolerance.

    Measured: during injection of the graft and within 3 hours of observation

  3. The payback of a platelet count> 20 000/microlitre bloodless. Measured by the blood count and platelet daily during hospitalization and at least 2 times a week.

    Measured: until the payback of the platelet count : measured daily during hospitalization and at least 2 times a week after

  4. The length of hospitalization since the beginning of conditioning until the first exit for more than 2 days.

    Measured: lenght of hospitalization since the beginning of conditioning

  5. The number of transfusions of red blood cells and platelets during the 1st hospitalization

    Measured: during the first hospitalization

  6. The incidence of graft loss or rejection within 6 months after transplantation, defined as the installation of a central cytopenia with loss of chimerism

    Measured: Within 6 months after transplantation

  7. The incidence of acute and chronic GVHD,determined by clinical examination Biopsies of target organs(skin, intestine, liver) will be conducted to confirm the diagnosis if possible.

    Measured: daily during hospitalization and at least twice weekly until D 100 after transplantation and then weekly or bi-monthly until one year post transplant.

  8. The mortality rate for transplantation in the year following the transplant,

    Measured: in the year following the transplant

  9. The incidence of relapse of hematologic malignancies,

    Measured: in the year following the transplant

  10. survival and disease-free survival in the year following the transplant

    Measured: in the year following the transplant

  11. Monitoring of immune reconstitution. This reconstruction will be followed by determining the rate of immunoglobulin G, M and A and the number of T lymphocytes CD3 +, CD4 + and CD8 + (assessments on days 15, 42, 60, 100, 180, 360).

    Measured: on days 15, 42, 60, 100, 180, 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2009 (estimated)
  2. Study startFeb 2010
  3. Primary completionOct 2013
  4. Study completionSep 2014

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01034449
Sponsor's protocol ID
CHUBX 2008/12
Other IDs
2008-006665-81, 2008
Acronym
GRAPA
Status last verified
Jan 2015
First submitted
16 Dec 2009
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Petersdorf EW. Risk assessment in haematopoietic stem cell transplantation: histocompatibility. Best Pract Res Clin Haematol. 2007 Jun;20(2):155-70. doi: 10.1016/j.beha.2006.09.001.

    PubMed 17448954

  • Koh LP, Chao NJ. Umbilical cord blood transplantation in adults using myeloablative and nonmyeloablative preparative regimens. Biol Blood Marrow Transplant. 2004 Jan;10(1):1-22. doi: 10.1016/j.bbmt.2003.09.009.

    PubMed 14752775

  • Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, McGlave PB, Miller JS, Verfaillie CM, Wagner JE. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood. 2005 Feb 1;105(3):1343-7. doi: 10.1182/blood-2004-07-2717. Epub 2004 Oct 5.

    PubMed 15466923

  • Castello S, Podesta M, Menditto VG, Ibatici A, Pitto A, Figari O, Scarpati D, Magrassi L, Bacigalupo A, Piaggio G, Frassoni F. Intra-bone marrow injection of bone marrow and cord blood cells: an alternative way of transplantation associated with a higher seeding efficiency. Exp Hematol. 2004 Aug;32(8):782-7. doi: 10.1016/j.exphem.2004.05.026.

    PubMed 15308330

  • Shpall EJ, Quinones R, Giller R, Zeng C, Baron AE, Jones RB, Bearman SI, Nieto Y, Freed B, Madinger N, Hogan CJ, Slat-Vasquez V, Russell P, Blunk B, Schissel D, Hild E, Malcolm J, Ward W, McNiece IK. Transplantation of ex vivo expanded cord blood. Biol Blood Marrow Transplant. 2002;8(7):368-76. doi: 10.1053/bbmt.2002.v8.pm12171483.

    PubMed 12171483

  • Ljungman P, Urbano-Ispizua A, Cavazzana-Calvo M, Demirer T, Dini G, Einsele H, Gratwohl A, Madrigal A, Niederwieser D, Passweg J, Rocha V, Saccardi R, Schouten H, Schmitz N, Socie G, Sureda A, Apperley J; European Group for Blood and Marrow. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: definitions and current practice in Europe. Bone Marrow Transplant. 2006 Mar;37(5):439-49. doi: 10.1038/sj.bmt.1705265.

    PubMed 16444286

  • Brunstein CG, Barker JN, Weisdorf DJ, DeFor TE, Miller JS, Blazar BR, McGlave PB, Wagner JE. Umbilical cord blood transplantation after nonmyeloablative conditioning: impact on transplantation outcomes in 110 adults with hematologic disease. Blood. 2007 Oct 15;110(8):3064-70. doi: 10.1182/blood-2007-04-067215. Epub 2007 Jun 14.

    PubMed 17569820

  • Gluckman E, Rocha V. Donor selection for unrelated cord blood transplants. Curr Opin Immunol. 2006 Oct;18(5):565-70. doi: 10.1016/j.coi.2006.07.014. Epub 2006 Aug 8.

    PubMed 16893632

  • Takahashi S. Leukemia: cord blood for allogeneic stem cell transplantation. Curr Opin Oncol. 2007 Nov;19(6):667-72. doi: 10.1097/CCO.0b013e3282f0e1a1.

    PubMed 17906469

  • Kobari L, Pflumio F, Giarratana M, Li X, Titeux M, Izac B, Leteurtre F, Coulombel L, Douay L. In vitro and in vivo evidence for the long-term multilineage (myeloid, B, NK, and T) reconstitution capacity of ex vivo expanded human CD34(+) cord blood cells. Exp Hematol. 2000 Dec;28(12):1470-80. doi: 10.1016/s0301-472x(00)00557-9.

    PubMed 11146169

  • Duchez P, Dazey B, Douay L, Vezon G, Ivanovic Z. An efficient large-scale thawing procedure for cord blood cells destined for selection and ex vivo expansion of CD34+ cells. J Hematother Stem Cell Res. 2003 Oct;12(5):587-9. doi: 10.1089/152581603322448295. No abstract available.

    PubMed 14594515

  • Dazey B, Duchez P, Letellier C, Vezon G, Ivanovic Z; French Cord Blood Network. Cord blood processing by using a standard manual technique and automated closed system "Sepax" (Kit CS-530). Stem Cells Dev. 2005 Feb;14(1):6-10. doi: 10.1089/scd.2005.14.6. No abstract available.

    PubMed 15725739

  • Ivanovic Z, Duchez P, Dazey B, Hermitte F, Lamrissi-Garcia I, Mazurier F, Praloran V, Reiffers J, Vezon G, Boiron JM. A clinical-scale expansion of mobilized CD 34+ hematopoietic stem and progenitor cells by use of a new serum-free medium. Transfusion. 2006 Jan;46(1):126-31. doi: 10.1111/j.1537-2995.2005.00675.x.

    PubMed 16398741

  • Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, Miller JS, Wagner JE. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced-intensity conditioning. Blood. 2003 Sep 1;102(5):1915-9. doi: 10.1182/blood-2002-11-3337. Epub 2003 May 8.

    PubMed 12738676

  • Ljungman P, Bregni M, Brune M, Cornelissen J, de Witte T, Dini G, Einsele H, Gaspar HB, Gratwohl A, Passweg J, Peters C, Rocha V, Saccardi R, Schouten H, Sureda A, Tichelli A, Velardi A, Niederwieser D; European Group for Blood and Marrow Transplantation. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe 2009. Bone Marrow Transplant. 2010 Feb;45(2):219-34. doi: 10.1038/bmt.2009.141. Epub 2009 Jul 6.

    PubMed 19584824

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing allogeneic transplant in people with Malignant Haematological Disease, run by University Hospital, Bordeaux at 3 sites 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 25 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The number of granulocytes, which will be evaluated daily after transplantation. And chimerism to be measured on the cells (total nucleated cells and lymphocytes) from peripheral blood on days 15, 42, 60, 100, 180, 360. (time frame: Daily for Blood évaluation and on days 15-42-60-100-180-360 for chimérisme évaluation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01034449, which also lists 15 linked publications.

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 1 Jun 2026.

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