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Precursor Cell Lymphoblastic Leukemia-LymphomaATLAS2015NCT02428517

Allogeneic Hematopoietic Cell Transplantation for Adult Acute Lymphoblastic Leukemia (2015)

An observational study of Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Asan Medical Center at 4 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a prospective multicenter observational study to evaluate the feasibility and the efficacy of the conditioning regimens which are modified by the donor differences and the age of recipients among patients who will receive allogeneic hematopoietic stem cell transplantation in their 1st or 2nd hematologic… Read more about this study

Who is it for?
Ages 15 years and older
What is being tested?
AlloHCT for Young/MSD, AlloHCT for Young/MUD&FMD and AlloHCT for Old/MSD
Type of treatment
Surgery or procedure
How many people
20 participants
Where
4 sitesSouth Korea
Study dates
Apr 2015to Jul 2016
Phase
Observational
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who are diagnosed as acute lymphoblastic leukemia, who achieve hematologic complete remission for the first time or for the second time after chemotherapy, and who wil receive allogeneic hematopoietic cell transplantation

Who may be able to join

  • Patients who has been previously diagnosed as one of the following disease;
  • Acute lymphoblastic leukemia
  • Biphenotypic acute leukemia with Philadelphia-positive chromosome or gene translocation
  • Patients whose disease status is one of the following;
  • First hematologic complete remission (HCR1)
  • Second hematologic complete remission (HCR2)
Show all 11Show fewer
  • 15 years of age and over.
  • With a suitable donor (matched sibling, well-matched unrelated, partially-matched unrelated, and haploidentical familial donor)
  • Adequate cardiac function (EF>45% via cardiac scan or EchoCG)
  • European Clinical Oncology Group (ECOG) performance status ≥grade 2 or Karnofsky scale >60% at the time of screening
  • All patients give written informed consent according to guidelines at institution's committee on human research.

Who cannot join

  • Acute lymphoblastic leukemia L3 type (Burkitt leukemia/lymphoma)
  • Biphenotypic acute leukemia without BCR-ABL1 translocation
  • Lymphoblastic lymphoma (bone marrow blast count is below 20% of mononuclear cells of bone marrow aspirate)
  • Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
  • Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
  • Male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc).
  • Patients with a diagnosis of prior malignancy (including hematologic malignancies such as acute leukemia, lymphoma, multiple myeloma, and myelodysplastic syndrome, etc) unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Inje University Busan Paik Hospital

    Busan

  • Inje University Haeundae Paik Hospital

    Busan

  • Asan Medical Center, University of Ulsan College of Medicine

    Seoul

  • Ulsan University Hospital, University of Ulsan College of Medicine

    Ulsan

Other trials in South Korea

About this study

Official title: A Prospective Study Evaluating the Efficacy of the Allogeneic Hematopoietic Cell Transplantation With Antithymocyte Globulin (ATG)-Based Conditioning of Adult Acute Lymphoblastic Leukemia in First / Second Complete Hematologic Remission

This study is a prospective multicenter observational study to evaluate the feasibility and the efficacy of the conditioning regimens which are modified by the donor differences and the age of recipients among patients who will receive allogeneic hematopoietic stem cell transplantation in their 1st or 2nd hematologic complete remission (CR).

Read the detailed description

Allogeneic hematopoietic cell transplantation (AlloHCT) is recommended as a post-remission therapy for patients with adult ALL, and reduced intensity conditioning has been tried to decrease treatment-related mortality (TRM) rate.

Recent results showed that reduced intensity conditioning can be safely and effectively used for alloHCT of adult patients with ALL. However, the reduced intensity conditioning (RIC) can increase the possibilities of hematologic relapse, especially due to the reduced anti-leukemic effect. Another challenge in performing alloHCT for ALL is the donor availability - the limited availability of matched sibling donor (MSD) and well-matched unrelated donor (WMUD) forces us to find the feasibility of alternative donors such as partially-matched unrelated donor (PMUD) or haploidentical familial donor (familial mismatched donor, FMD).

The previous study (NCT0137764) which the investigators performed showed that the use of RIC and alternative donor was feasible. However, the incidence of relapse was slightly higher among patients who received RIC when the investigators analyzed the interim analysis results. Especially, the graft-versus-host disease (GVHD) incidence was relatively higher among patients who received alloHCT from MSD, and the investigators think that the addition of antithymocyte globulin will reduce the incidence of GVHD for these patients.

In this study, the dose of busulfan will be increased when the recipients are below 55 years old, irrespective of donor type. The investigators will also define the partially matched donor exactly and find the feasibility of PMUD and FMD again. Another endpoint for this study is to find out whether the addition of antithymocyte globulin may be helpful in preventing the GVHD incidence for patients who received alloHCT from MSD without increasing the chance of hematologic relapse.

Being tested
AlloHCT for Young/MSD, AlloHCT for Young/MUD&FMD, AlloHCT for Old/MSD, AlloHCT for Old/MUD&FMD
Keywords
acute lymphoblastic leukemia, allogeneic hematopoietic stem cell transplantation, alternative hematopoietic stem cell donor, busulfan, antithymocyte globulin
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • AlloHCT for Young/MSDProcedure or surgery

    Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-4) Cyclophosphamide 60 mg/kg (D-3 to D-2) Thymoglobulin 1.5 mg/kg (D-3 to D-1)

  • AlloHCT for Young/MUD&FMDProcedure or surgery

    Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-4) Fludarabine 30 mg/m2 (D-7 to D-2) Thymoglobulin 3.0 mg/kg (D-3 to D-1)

  • AlloHCT for Old/MSDProcedure or surgery

    Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-6) Fludarabine 30 mg/m2 (D-7 to D-2) Thymoglobulin 1.5 mg/kg (D-3 to D-1)

  • AlloHCT for Old/MUD&FMDProcedure or surgery

    Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-6) Fludarabine 30 mg/m2 (D-7 to D-2) Thymoglobulin 3.0 mg/kg (D-3 to D-1)

Study groups in NCT02428517
Study groupRoleWhat they receive
Young/MSDPatients who are <55 years old, and will receive alloHCT for Young/MSD
Receives: Procedure: AlloHCT for Young/MSD
Young/MUD&FMDPatients who are <55 years old, and will receive alloHCT for Young/MUD\&FMD
Receives: Procedure: AlloHCT for Young/MUD&FMD
Old/MSDPatients who are >=55 years old, and will receive alloHCT for Old/MSD
Receives: Procedure: AlloHCT for Old/MSD
Old/MUD&FMDPatients who are >=55 years old, and will receive alloHCT for Old/MUD\&FMD
Receives: Procedure: AlloHCT for Old/MUD&FMD

What is being measured

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

  1. relapse-free survival (RFS) rate

    time from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse

    Measured: 2 years

Secondary outcomes (18)

  1. relapse-free survival (RFS) rate

    time from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse

    Measured: 5 years

  2. overall survival (OS) rate

    time from the diagnosis of disease to death/ time from the enrollment of this trial to death

    Measured: 2 years

  3. overall survival (OS) rate

    time from the diagnosis of disease to death/ time from the enrollment of this trial to death

    Measured: 5 years

  4. cumulative incidence of relapse

    from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse

    Measured: 2 years

  5. cumulative incidence of relapse

    from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse

    Measured: 5 years

  6. treatment-related mortality rate

    after enrollment of this trial

    Measured: 100 days

  7. treatment-related mortality rate

    after enrollment of this trial

    Measured: 1 year

  8. treatment-related mortality rate

    after enrollment of this trial

    Measured: 2 years

  9. treatment-related mortality rate

    after enrollment of this trial

    Measured: 5 years

  10. cumulative incidence of acute graft-versus-host disease

    after enrollment of this trial

    Measured: 100 days

  11. cumulative incidence of acute graft-versus-host disease

    after enrollment of this trial

    Measured: 1 year

  12. cumulative incidence of acute graft-versus-host disease

    after enrollment of this trial

    Measured: 2 years

  13. cumulative incidence of acute graft-versus-host disease

    after enrollment of this trial

    Measured: 5 years

  14. cumulative incidence of chronic graft-versus-host disease

    after enrollment of this trial

    Measured: 100 days

  15. cumulative incidence of chronic graft-versus-host disease

    after enrollment of this trial

    Measured: 1 year

  16. cumulative incidence of chronic graft-versus-host disease

    after enrollment of this trial

    Measured: 2 years

  17. cumulative incidence of chronic graft-versus-host disease

    after enrollment of this trial

    Measured: 5 years

  18. molecular relapse-free survival

    after enrollment of this trial / after achieving molecular CR (for Ph-positive ALL)

    Measured: 2 years

Timeline

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

  1. First posted28 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJul 2016
  4. Study completionJul 2016

Why it stopped: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02428517
Sponsor's protocol ID
AMC-ALLO-044
Acronym
ATLAS2015
Status last verified
Jul 2018
First submitted
21 Apr 2015
Last updated
20 Jul 2018
Results posted
No
Data monitoring committee
No

Publications

  • Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7.

    PubMed 24399786

  • Ma H, Sun H, Sun X. Survival improvement by decade of patients aged 0-14 years with acute lymphoblastic leukemia: a SEER analysis. Sci Rep. 2014 Feb 27;4:4227. doi: 10.1038/srep04227.

    PubMed 24572378

  • Forman SJ, Rowe JM. The myth of the second remission of acute leukemia in the adult. Blood. 2013 Feb 14;121(7):1077-82. doi: 10.1182/blood-2012-08-234492. Epub 2012 Dec 14.

    PubMed 23243288

  • Goldstone AH, Richards SM, Lazarus HM, Tallman MS, Buck G, Fielding AK, Burnett AK, Chopra R, Wiernik PH, Foroni L, Paietta E, Litzow MR, Marks DI, Durrant J, McMillan A, Franklin IM, Luger S, Ciobanu N, Rowe JM. In adults with standard-risk acute lymphoblastic leukemia, the greatest benefit is achieved from a matched sibling allogeneic transplantation in first complete remission, and an autologous transplantation is less effective than conventional consolidation/maintenance chemotherapy in all patients: final results of the International ALL Trial (MRC UKALL XII/ECOG E2993). Blood. 2008 Feb 15;111(4):1827-33. doi: 10.1182/blood-2007-10-116582. Epub 2007 Nov 29.

    PubMed 18048644

  • Bray RA, Hurley CK, Kamani NR, Woolfrey A, Muller C, Spellman S, Setterholm M, Confer DL. National marrow donor program HLA matching guidelines for unrelated adult donor hematopoietic cell transplants. Biol Blood Marrow Transplant. 2008 Sep;14(9 Suppl):45-53. doi: 10.1016/j.bbmt.2008.06.014. No abstract available.

    PubMed 18721780

  • Lee SJ, Klein J, Haagenson M, Baxter-Lowe LA, Confer DL, Eapen M, Fernandez-Vina M, Flomenberg N, Horowitz M, Hurley CK, Noreen H, Oudshoorn M, Petersdorf E, Setterholm M, Spellman S, Weisdorf D, Williams TM, Anasetti C. High-resolution donor-recipient HLA matching contributes to the success of unrelated donor marrow transplantation. Blood. 2007 Dec 15;110(13):4576-83. doi: 10.1182/blood-2007-06-097386. Epub 2007 Sep 4.

    PubMed 17785583

  • Weisdorf D, Spellman S, Haagenson M, Horowitz M, Lee S, Anasetti C, Setterholm M, Drexler R, Maiers M, King R, Confer D, Klein J. Classification of HLA-matching for retrospective analysis of unrelated donor transplantation: revised definitions to predict survival. Biol Blood Marrow Transplant. 2008 Jul;14(7):748-58. doi: 10.1016/j.bbmt.2008.04.003.

    PubMed 18541193

  • Petersdorf EW, Anasetti C, Martin PJ, Gooley T, Radich J, Malkki M, Woolfrey A, Smith A, Mickelson E, Hansen JA. Limits of HLA mismatching in unrelated hematopoietic cell transplantation. Blood. 2004 Nov 1;104(9):2976-80. doi: 10.1182/blood-2004-04-1674. Epub 2004 Jul 13.

    PubMed 15251989

  • Ballen KK, Koreth J, Chen YB, Dey BR, Spitzer TR. Selection of optimal alternative graft source: mismatched unrelated donor, umbilical cord blood, or haploidentical transplant. Blood. 2012 Mar 1;119(9):1972-80. doi: 10.1182/blood-2011-11-354563. Epub 2011 Dec 30.

    PubMed 22210876

  • Koh LP, Rizzieri DA, Chao NJ. Allogeneic hematopoietic stem cell transplant using mismatched/haploidentical donors. Biol Blood Marrow Transplant. 2007 Nov;13(11):1249-67. doi: 10.1016/j.bbmt.2007.08.003.

    PubMed 17950913

  • Reisner Y, Hagin D, Martelli MF. Haploidentical hematopoietic transplantation: current status and future perspectives. Blood. 2011 Dec 1;118(23):6006-17. doi: 10.1182/blood-2011-07-338822. Epub 2011 Sep 14.

    PubMed 21921045

  • Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28.

    PubMed 21715313

  • de Lima M, Anagnostopoulos A, Munsell M, Shahjahan M, Ueno N, Ippoliti C, Andersson BS, Gajewski J, Couriel D, Cortes J, Donato M, Neumann J, Champlin R, Giralt S. Nonablative versus reduced-intensity conditioning regimens in the treatment of acute myeloid leukemia and high-risk myelodysplastic syndrome: dose is relevant for long-term disease control after allogeneic hematopoietic stem cell transplantation. Blood. 2004 Aug 1;104(3):865-72. doi: 10.1182/blood-2003-11-3750. Epub 2004 Apr 15.

    PubMed 15090449

  • Kiehl MG, Kraut L, Schwerdtfeger R, Hertenstein B, Remberger M, Kroeger N, Stelljes M, Bornhaeuser M, Martin H, Scheid C, Ganser A, Zander AR, Kienast J, Ehninger G, Hoelzer D, Diehl V, Fauser AA, Ringden O. Outcome of allogeneic hematopoietic stem-cell transplantation in adult patients with acute lymphoblastic leukemia: no difference in related compared with unrelated transplant in first complete remission. J Clin Oncol. 2004 Jul 15;22(14):2816-25. doi: 10.1200/JCO.2004.07.130.

    PubMed 15254049

  • Yakoub-Agha I, Mesnil F, Kuentz M, Boiron JM, Ifrah N, Milpied N, Chehata S, Esperou H, Vernant JP, Michallet M, Buzyn A, Gratecos N, Cahn JY, Bourhis JH, Chir Z, Raffoux C, Socie G, Golmard JL, Jouet JP; French Society of Bone Marrow Transplantation and Cell Therapy. Allogeneic marrow stem-cell transplantation from human leukocyte antigen-identical siblings versus human leukocyte antigen-allelic-matched unrelated donors (10/10) in patients with standard-risk hematologic malignancy: a prospective study from the French Society of Bone Marrow Transplantation and Cell Therapy. J Clin Oncol. 2006 Dec 20;24(36):5695-702. doi: 10.1200/JCO.2006.08.0952. Epub 2006 Nov 20.

    PubMed 17116940

Questions about this trial

What is this clinical trial studying?

An observational study of Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Asan Medical Center at 4 sites in South Korea.

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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. 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.

Are results available for this study?

The study was stopped early (reason given: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.). Results are not available in the source record.

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?

relapse-free survival (RFS) rate (time frame: 2 years). 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 NCT02428517, which also lists 37 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 20 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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