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LeukemiaPhase 1/2NCT02328885

Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

A Phase 1/2 study testing DLI of the 20 fraction of the UCBT in people with Leukemia, run by Banc de Sang i Teixits at 5 sites in Spain.

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

Pilot, multicentric, open-label, single-arm, phase I-II clinical trial to evaluate the safety and efficacy of a novel Umbilical Cord Blood Transplantation (UCBT) platform, that consists of a UCBT of the 80 fraction, followed by a Donor Lymphocyte Infusion (DLI) of the 20 fraction (between 60 and 90 days after… Read more about this study

Who is it for?
Ages Up to 60 years
Conditions the study is for
Leukemia
What is being tested?
DLI of the 20 fraction of the UCBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
5 sitesSpain
Study dates
Jul 2014to 22 Mar 2017
Phase
Phase 1/2
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 Up to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • At the time of transplantation:
  • Patients under 60 years with proposal UCBT according to assistance protocol
  • Diagnosis of high-risk acute leukemia with an indication of allogenic transplantation
  • Frozen UCB bag split into two bags: one with the 80% of the product and another with the 20%
  • Presence of at least 1.2E9 total nucleated cells and> 1E5 CD34 / kg and> 6E6 CD34 + in fraction 80%
  • 4/6 or better compatibility taking Human Leukocyte Antigen (HLA) HLA-A, HLA-B by antigenic resolution and DRB1 by allelic resolution
Show all 12Show fewer
  • The patient (or legal representative if required) has signed the informed consent
  • At the time of DLI:
  • Documented cord blood engraftment
  • The patient has had no Graft Versus Host Disease (GVHD) during the first 60 days post-transplantation or, if present, receives less than 10 milligrams of prednisone at the time of the DLI or <0.2 mg / kg / day of prednisone for pediatric patients (<16 years).
  • The patient has less than 200 CD4 + cells per microliter on peripheral blood at 60 days (± 7 days) post-transplantation
  • The patient (or legal representative if required) has signed the informed consent

Who cannot join

  • At the time of transplantation:
  • Simultaneous participation in another clinical trial or treatment with other research phase product within 30 days prior to inclusion in the study.
  • Pregnant women or those who intend to become pregnant within 12 months after the signing of the informed consent or not taking proper contraceptive measures according to investigator criteria.
  • Breastfeeding women
  • Other pathologies or circumstances that may compromise the patient's participation in the study according to the criteria of the investigator.
  • At the time of DLI:
  • Grade III-IV GVHD after allogeneic UCB
  • Prednisone treatment (> 10 mg total per day in adults or> 0.2 mg / kg / day prednisone for pediatric patients)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital de Sant Pau

    Barcelona, 08025

  • Hospital Vall Hebron

    Barcelona, 08035

  • Hospital de Sant Pau

    Barcelona, 08041

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

Pilot, multicentric, open-label, single-arm, phase I-II clinical trial to evaluate the safety and efficacy of a novel Umbilical Cord Blood Transplantation (UCBT) platform, that consists of a UCBT of the 80 fraction, followed by a Donor Lymphocyte Infusion (DLI) of the 20 fraction (between 60 and 90 days after transplantation).

Read the detailed description

Multicenter, open-label, single-arm, phase I-II pilot study in which a minimum of 20 patients will enter the study with the primary objective to assess the safety and secondary objective to assess efficacy in relation to immune reconstitution followed by a new platform of treatment consisting of initial cord blood unit 80 fraction transplantation, followed by a prophylactic donor lymphocyte infusion (DLI) of the fraction 20 of the cord blood unit. The second infusion will take place between 60 and 90 days after transplantation.

Conditions
Leukemia
Being tested
DLI of the 20 fraction of the UCBT
Keywords
high-risk acute leukemia, graft versus leukemia, DLI, UCBT
Medical subject headings
Leukemia

What participants receive

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

  • DLI of the 20 fraction of the UCBTDrug

    Administration of 20 fraction of the UCBT

Study groups in NCT02328885
Study groupRoleWhat they receive
ExperimentalExperimentalDLI of the 20 fraction of the UCBT
Receives: Drug: DLI of the 20 fraction of the UCBT

What is being measured

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

  1. Safety assessment

    Adverse events

    Measured: 1 year

Secondary outcomes (8)

  1. Immune reconstitution:

    Subpopulations of Lymphocytes T: CD4 and CD8

    Measured: 1 year

  2. Immunological reconstitution:

    NK cells

    Measured: 1 year

  3. Immune regeneration

    Lymphocytes B

    Measured: 1 year

  4. Infections in treated patients

    Incidence of infections

    Measured: 1 year

  5. Infections in the treated patients

    Type of infections

    Measured: 1 year

  6. Relapse of leukemia

    Incidence of relapse

    Measured: 1 year

  7. Survival curves

    Global and disease-free survival

    Measured: 1 year

  8. Mortality

    Incidence of early and late mortality

    Measured: 1 year

Timeline

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

  1. First posted31 Dec 2014 (estimated)
  2. Study startJul 2014
  3. Primary completion22 Mar 2017
  4. Study completion22 Mar 2017

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
DLI
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02328885
Sponsor's protocol ID
I.2013.004
Status last verified
Dec 2021
First submitted
16 Dec 2014
Last updated
8 Dec 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Dohner H, Estey EH, Amadori S, Appelbaum FR, Buchner T, Burnett AK, Dombret H, Fenaux P, Grimwade D, Larson RA, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz MA, Sierra J, Tallman MS, Lowenberg B, Bloomfield CD; European LeukemiaNet. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010 Jan 21;115(3):453-74. doi: 10.1182/blood-2009-07-235358. Epub 2009 Oct 30.

    PubMed 19880497

  • Cornelissen JJ, van Putten WL, Verdonck LF, Theobald M, Jacky E, Daenen SM, van Marwijk Kooy M, Wijermans P, Schouten H, Huijgens PC, van der Lelie H, Fey M, Ferrant A, Maertens J, Gratwohl A, Lowenberg B. Results of a HOVON/SAKK donor versus no-donor analysis of myeloablative HLA-identical sibling stem cell transplantation in first remission acute myeloid leukemia in young and middle-aged adults: benefits for whom? Blood. 2007 May 1;109(9):3658-66. doi: 10.1182/blood-2006-06-025627. Epub 2007 Jan 9.

    PubMed 17213292

  • Koreth J, Schlenk R, Kopecky KJ, Honda S, Sierra J, Djulbegovic BJ, Wadleigh M, DeAngelo DJ, Stone RM, Sakamaki H, Appelbaum FR, Dohner H, Antin JH, Soiffer RJ, Cutler C. Allogeneic stem cell transplantation for acute myeloid leukemia in first complete remission: systematic review and meta-analysis of prospective clinical trials. JAMA. 2009 Jun 10;301(22):2349-61. doi: 10.1001/jama.2009.813.

    PubMed 19509382

  • Lodewyck T, Cornelissen JJ. Allogeneic stem cell transplantation in acute myeloid leukemia: a risk-adapted approach. Blood Rev. 2008 Nov;22(6):293-302. doi: 10.1016/j.blre.2008.03.008. Epub 2008 May 1.

    PubMed 18455284

  • Messner HA. How good is allogeneic transplantation for high-risk patients with AML? Best Pract Res Clin Haematol. 2006;19(2):329-32. doi: 10.1016/j.beha.2005.11.007.

    PubMed 16516130

  • Schlenk RF, Dohner K, Mack S, Stoppel M, Kiraly F, Gotze K, Hartmann F, Horst HA, Koller E, Petzer A, Grimminger W, Kobbe G, Glasmacher A, Salwender H, Kirchen H, Haase D, Kremers S, Matzdorff A, Benner A, Dohner H. Prospective evaluation of allogeneic hematopoietic stem-cell transplantation from matched related and matched unrelated donors in younger adults with high-risk acute myeloid leukemia: German-Austrian trial AMLHD98A. J Clin Oncol. 2010 Oct 20;28(30):4642-8. doi: 10.1200/JCO.2010.28.6856. Epub 2010 Aug 30.

    PubMed 20805454

  • Appelbaum FR. Pursuing the goal of a donor for everyone in need. N Engl J Med. 2012 Oct 18;367(16):1555-6. doi: 10.1056/NEJMe1209982. No abstract available.

    PubMed 23075182

  • Barker JN, Byam CE, Kernan NA, Lee SS, Hawke RM, Doshi KA, Wells DS, Heller G, Papadopoulos EB, Scaradavou A, Young JW, van den Brink MR. Availability of cord blood extends allogeneic hematopoietic stem cell transplant access to racial and ethnic minorities. Biol Blood Marrow Transplant. 2010 Nov;16(11):1541-8. doi: 10.1016/j.bbmt.2010.08.011. Epub 2010 Aug 25.

    PubMed 20800103

  • Byrd JC, Mrozek K, Dodge RK, Carroll AJ, Edwards CG, Arthur DC, Pettenati MJ, Patil SR, Rao KW, Watson MS, Koduru PR, Moore JO, Stone RM, Mayer RJ, Feldman EJ, Davey FR, Schiffer CA, Larson RA, Bloomfield CD; Cancer and Leukemia Group B (CALGB 8461). Pretreatment cytogenetic abnormalities are predictive of induction success, cumulative incidence of relapse, and overall survival in adult patients with de novo acute myeloid leukemia: results from Cancer and Leukemia Group B (CALGB 8461). Blood. 2002 Dec 15;100(13):4325-36. doi: 10.1182/blood-2002-03-0772. Epub 2002 Aug 1.

    PubMed 12393746

  • Schlenk RF, Dohner K, Krauter J, Frohling S, Corbacioglu A, Bullinger L, Habdank M, Spath D, Morgan M, Benner A, Schlegelberger B, Heil G, Ganser A, Dohner H; German-Austrian Acute Myeloid Leukemia Study Group. Mutations and treatment outcome in cytogenetically normal acute myeloid leukemia. N Engl J Med. 2008 May 1;358(18):1909-18. doi: 10.1056/NEJMoa074306.

    PubMed 18450602

  • Krauter J, Wagner K, Schafer I, Marschalek R, Meyer C, Heil G, Schaich M, Ehninger G, Niederwieser D, Krahl R, Buchner T, Sauerland C, Schlegelberger B, Dohner K, Dohner H, Schlenk RF, Ganser A. Prognostic factors in adult patients up to 60 years old with acute myeloid leukemia and translocations of chromosome band 11q23: individual patient data-based meta-analysis of the German Acute Myeloid Leukemia Intergroup. J Clin Oncol. 2009 Jun 20;27(18):3000-6. doi: 10.1200/JCO.2008.16.7981. Epub 2009 Apr 20.

    PubMed 19380453

  • MATHE G, AMIEL JL, SCHWARZENBERG L, CATTAN A, SCHNEIDER M, DEVRIES MJ, TUBIANA M, LALANNE C, BINET JL, PAPIERNIK M, SEMAN G, MATSUKURA M, MERY AM, SCHWARZMANN V, FLAISLER A. SUCCESSFUL ALLOGENIC BONE MARROW TRANSPLANTATION IN MAN: CHIMERISM, INDUCED SPECIFIC TOLERANCE AND POSSIBLE ANTI-LEUKEMIC EFFECTS. Blood. 1965 Feb;25:179-96. No abstract available.

    PubMed 14267694

  • Horowitz MM, Gale RP, Sondel PM, Goldman JM, Kersey J, Kolb HJ, Rimm AA, Ringden O, Rozman C, Speck B, et al. Graft-versus-leukemia reactions after bone marrow transplantation. Blood. 1990 Feb 1;75(3):555-62.

    PubMed 2297567

  • Zittoun RA, Mandelli F, Willemze R, de Witte T, Labar B, Resegotti L, Leoni F, Damasio E, Visani G, Papa G, et al. Autologous or allogeneic bone marrow transplantation compared with intensive chemotherapy in acute myelogenous leukemia. European Organization for Research and Treatment of Cancer (EORTC) and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) Leukemia Cooperative Groups. N Engl J Med. 1995 Jan 26;332(4):217-23. doi: 10.1056/NEJM199501263320403.

    PubMed 7808487

  • Cassileth PA, Harrington DP, Appelbaum FR, Lazarus HM, Rowe JM, Paietta E, Willman C, Hurd DD, Bennett JM, Blume KG, Head DR, Wiernik PH. Chemotherapy compared with autologous or allogeneic bone marrow transplantation in the management of acute myeloid leukemia in first remission. N Engl J Med. 1998 Dec 3;339(23):1649-56. doi: 10.1056/NEJM199812033392301.

    PubMed 9834301

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DLI of the 20 fraction of the UCBT in people with Leukemia, run by Banc de Sang i Teixits at 5 sites in Spain.

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 12 inclusion and 8 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety assessment (time frame: 1 year). 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 NCT02328885, which also lists 44 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 8 Dec 2021.

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