Acute Myeloid LeukemiaPhase 2/3NCT01751997

Family-mismatched/Haploidentical Donors Versus Matched Unrelated Donors

A Phase 2/3 study testing Transplants from 8/8-matched Unrelated donors and Transplants from family-mismatched/haploidentical donors in people with Acute Myeloid Leukemia, run by Byung-Sik Cho at 1 site in South Korea.

Completed

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

Official record

Search all trials

Trial summary

This study will compare the clinical outcomes of transplants from family-mismatched/haploidentical donors (FMT) with transplants from 8/8-matched unrelated donor (MUT), which is a current gold standard donors when lacking of HLA-matched-siblings 1. Read more about this study

Who is it for?: Ages 17 to 65 years
Conditions the study is for: Acute Myeloid Leukemia
What is being tested?: Transplants from 8/8-matched Unrelated donors and Transplants from family-mismatched/haploidentical donors
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 1 siteSouth Korea
Study dates: Jan 2013to 31 Dec 2019
Phase: Phase 2/3
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 17 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients with AML aged from 18 to 65 years
Eastern Cooperative Oncology Group (ECOG) performance < 2
High risk group for relapse
Complete remission (CR) 1 with unfavorable prognostic factor; presenting white blood cell > 100,000/microliter or prior myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) or MDS/MPN or cytogenetics \& molecular features (intermediate and adverse)
CR2 or CR3 at transplantation
No HLA-matched sibling and unrelated donor (HLA-A, -B, -C, and -DRB1)
Acceptable organ function defined as serum creatinine < 2 mg/dl, unless considered due to leukemia and serum bilirubin < 3 mg/dl, unless considered due to leukemia
Written informed consent form

Who cannot join

Active uncontrolled infections
Corrected pulmonary diffusion capacity of <40%
Cardiac ejection fraction of <35%
ECOG performance status :2, 3, 4
Active central nervous system involvement of disease
Serological evidence of infection with HIV
Pregnancy or breastfeeding
Patient who are not suitable for the trial in accordance with principal investigator's decision

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Catholic Blood and Marrow Transplantation Center, Seoul St. Mary's Hospital
Seoul, 137-701

Other trials in South Korea

About this study

Official title: The Comparison of Transplantation From Family-mismatched/Haploidentical Donors With Matched Unrelated Donors in Adult Patients With Acute Myeloid Leukemia

Primary objectives: Overall survival of FMT may be similar to that of MUT
Secondary objectives:
Comparison of disease-free survival, relapse, non-relapse mortality, immune reconstitution cytomegalovirus infection, and acute or chronic graft-versus-host disease between FMT and MUT. ii. Investigation of possible biomarkers related with above events after transplantation

Read the detailed description

For patients lacking an HLA-identical sibling, 8/8-matched unrelated donors are currently the "gold standard" for a donor, since outcomes after HLA-identical sibling have been compared to 8/8-matched unrelated donors. Currently, there are three alternative graft sources, including mismatched unrelated donors, familial mismatch/haploidentical donors, and umbilical cord bloods. Compared with other sources, transplants from familial mismatch/haploidentical donors (FMT) have the benefit of an immediate availability of a donor, particularly for those patients who urgently need transplantation. Initial reports had characterized FMT to a poor engraftment and a high incidence of graft-versus-host disease. However, outcomes of FMT have significantly improved over the past decade in the optimization of conditioning regimen and graft selection to allow a stable engraftment across major HLA barriers, with promising leukemia-free survival in adults with acute leukemia. Despite the encouraging results and potential benefit of FMT, there have been few studies comparing clinical outcomes of FMT with other donor types, particularly in acute myeloid leukemia (AML) as a single disease. Since August 2008, we have been continuously performing FMT using unmanipulated donor cells and a less aggressive conditioning regimen in high-risk AML lacking an HLA-identical sibling, 8/8 or 7/8-matched unrelated donors. We reported the feasibility of FMT using our novel reduced-intensity regimen without ex vivo T-cell depletion, showing early results similar to outcomes of transplant from 8/8-matched unrelated donors (MUT). This study will test the hypothesis that overall survival at 3 years after FMT is similar to overall survival after MUT.

Conditions: Acute Myeloid Leukemia
Being tested: Transplants from 8/8-matched Unrelated donors, Transplants from family-mismatched/haploidentical donors
Medical subject headings: Leukemia, Myeloid, Acute

What participants receive

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

Transplants from 8/8-matched Unrelated donorsDrug
- Myeloablative conditioning
1. Total body irradiation; 165 cGy, every 12 hours, 8 doses, days -7 to -4 (total 1320 cGy)
2. Cyclophosphamide; 60 mg/kg/day, IV for 30 minutes, days -3 to -2 (total 120 mg/kg)
3. Antithymocyte globulin (ATG); 1.25 mg/kg/day, IV for 6 hours, days -3 to -2, (total 2.5 mg/kg)
- Reduced-intensity conditioning; older patients (age > 55 years) and/or patients with comorbidities
1. Fludarabine; 30 mg/m^2/day, IV for 1 hour, days -8 to -4 (total 150 mg/m^2)
2. Busulfex; 3.2 mg/kg/day, IV for 3 hours, days -3 to -2 (total 6.4 mg/kg)
3. Total body irradiation; 200 cGy, every 12 hours 2 doses, days -1 (total 400 cGy)
4. ATG; 1.25 mg/kg/day, IV for 6 hours, days -3 to -2, (total 2.5 mg/kg)
- GVHD prophylaxis
1. Tacrolimus; 0.03 mg/kg/day, IV for 24 hours from day -1 (0.12 mg/kg/day, PO, if tolerable)
2. Methotrexate; 5 mg/m^2/day, IV push, days +1, +3, +6, +11
Transplants from family-mismatched/haploidentical donorsDrug
- Reduced-intensity conditioning
1. Total body irradiation; 200 cGy, every 12 hours, 4 doses, days -9 to -8 (total 800 cGy)
2. Fludarabine; 30 mg/m^2/day, IV for 1 hour, days -7 to -3 (total 150 mg/m^2)
3. Busulfex; 3.2 mg/kg/day, IV for 3 hours, days -6 to -5 (total 6.4 mg/kg)
4. ATG; 1.25 mg/kg/day, IV for 6 hours, days -4 to -1 (total 5.0 mg/kg)
- GVHD prophylaxis
1. Tacrolimus; 0.03 mg/kg/day, IV for 24 hours from day -1 (0.12 mg/kg/day, PO, if tolerable)
2. Methotrexate; 5 mg/m^2/day, IV push, days +1, +3, +6, +11

Study groups in NCT01751997
Study group	Role	What they receive
Transplants from 8/8-matched unrelated	Active comparator	Participants will receive transplants from 8/8-matched unrelated donors using myeloablative or reduced-intensity conditioning according to age or comorbidity. Receives: Drug: Transplants from 8/8-matched Unrelated donors
Transplants from family-mismatched/haploidentical donors	Experimental	Participants will receive FMT using a reduced intensity conditioning regimens. Receives: Drug: Transplants from family-mismatched/haploidentical donors

What is being measured

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

Overall survival
Overall survival is defined as the time interval between date of enrollment and death from any cause or for surviving patients, to last follow-up
Measured: annually through 3 years

Secondary outcomes (16)

Neutrophil recovery
defined as achieving an absolute neutrophil count greater than or equal to 500/mm^3 for three consecutive measurements on three difference days. The first of the 3 days will be designated the day of neutrophil recovery.
Measured: 56 days
Primary Graft failure
defined as failure to achieve a neutrophil count greater than 500/mm^3 for 3 consecutive days at any time after transplantation.
Measured: 56 days
Secondary Graft failure
defined as the development of an absolute neutrophil count less than 500/mm^3 after achievement of initial engraftment in the absence of recurrent disease.
Measured: 100 days
Platelet recovery
defined as the first day of a sustained platelet count greater than 20,000/mm^3 without platelet transfusions in preceding 7 days. The first day of the sustained platelet count will be designated the day of platelet engraftment.
Measured: 100 days and 180 days
Donor cell engraftment
Donor cell engraftment is defined as donor chimerism greater than or equal 5% on Day 56 after transplantation. Chimerism may be evaluated in whole blood or blood cell fractions, including cluster of differentiation (CD) 3 and CD33 or CD15 fractions. The actual measurement dates may be within +/- 7 days of the above recommended time points.
Measured: 56 days
Acute graft-versus-host disease (aGVHD)
The cumulative incidence of aGVHD (grade II-IV and III-IV) will be determined. The time to onset of aGVHD will be recorded, as well as the maximum grade achieved.
Measured: every 3 months through 3 years
Chronic graft-versus-host disease (cGVHD)
The cumulative incidence of cGVHD will be determined. Data will be collected directly from providers and chart review according to the recommendations of the NIH Consensus Conference. The NIH global severity scores of mild, moderate, and severe cGVHD will be assessed.
Measured: every 3 months through 3 years
Disease free survival
defined as the time interval from date of enrollment and time to relapse/progression, to death or to last follow-up
Measured: annually through year 3
Non-relapse mortality
The cumulative incidence of non-relapse mortality will be estimated at Days 100, 180, and at 1 and 2 years after transplantation. An event for this endpoint is death without evidence of disease progression or recurrence
Measured: annually through year 3
Infection
All grade 2 and 3 infections will be reported. Grade 1 cytomegalovirus infections through Day 56 will also be reported.
Measured: annually through year 3
WT1 MRD assessment
WT1 MRD assessment
Measured: before and 1 month after transplantation, then every 3 months through 3 years
BAALC MRD assessment
BAALC MRD assessment
Measured: before and 1 month after transplantation, then every 3 months through 3 years
NGS-based MRD assessment
NGS-based MRD assessment
Measured: before and 1 month after transplantation, then every 3 months through 3 year
T cells reconstitution
T cell subsets
Measured: before and 2 weeks and 1 month after transplantation, then every 3 months through 1 year
NK cells reconstitution
NK cell subsets
Measured: before and 2 weeks and 1 month after transplantation, then every 3 months through 1 year
B cells reconstitution
B cells
Measured: before and 2 weeks and 1 month after transplantation, then every 3 months through 1 year

Timeline

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

Jan 201331 Dec 2019

First posted18 Dec 2012 (estimated)
Study startJan 2013
Primary completion21 May 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2/3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01751997
Sponsor's protocol ID: CBMTC-AML-1
Status last verified: Apr 2024
First submitted: 14 Dec 2012
Last updated: 19 Apr 2024
Results posted: No
Data monitoring committee: No

Publications

Aversa F. Haploidentical haematopoietic stem cell transplantation for acute leukaemia in adults: experience in Europe and the United States. Bone Marrow Transplant. 2008 Mar;41(5):473-81. doi: 10.1038/sj.bmt.1705966. Epub 2008 Jan 7.
PubMed 18176612
Ruggeri A, Ciceri F, Gluckman E, Labopin M, Rocha V; Eurocord and Acute Leukemia Working Party of the European Blood and Marrow Transplant Group. Alternative donors hematopoietic stem cells transplantation for adults with acute myeloid leukemia: Umbilical cord blood or haploidentical donors? Best Pract Res Clin Haematol. 2010 Jun;23(2):207-16. doi: 10.1016/j.beha.2010.06.002.
PubMed 20837332
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
Beatty PG, Clift RA, Mickelson EM, Nisperos BB, Flournoy N, Martin PJ, Sanders JE, Stewart P, Buckner CD, Storb R, et al. Marrow transplantation from related donors other than HLA-identical siblings. N Engl J Med. 1985 Sep 26;313(13):765-71. doi: 10.1056/NEJM198509263131301.
PubMed 3897863
Anasetti C, Hansen JA. Effect of HLA incompatibility in marrow transplantation from unrelated and HLA-mismatched related donors. Transfus Sci. 1994 Sep;15(3):221-30. doi: 10.1016/0955-3886(94)90134-1.
PubMed 10155543
Henslee-Downey PJ, Abhyankar SH, Parrish RS, Pati AR, Godder KT, Neglia WJ, Goon-Johnson KS, Geier SS, Lee CG, Gee AP. Use of partially mismatched related donors extends access to allogeneic marrow transplant. Blood. 1997 May 15;89(10):3864-72.
PubMed 9160695
Aversa F, Terenzi A, Tabilio A, Falzetti F, Carotti A, Ballanti S, Felicini R, Falcinelli F, Velardi A, Ruggeri L, Aloisi T, Saab JP, Santucci A, Perruccio K, Martelli MP, Mecucci C, Reisner Y, Martelli MF. Full haplotype-mismatched hematopoietic stem-cell transplantation: a phase II study in patients with acute leukemia at high risk of relapse. J Clin Oncol. 2005 May 20;23(15):3447-54. doi: 10.1200/JCO.2005.09.117. Epub 2005 Mar 7.
PubMed 15753458
Ruggeri L, Mancusi A, Capanni M, Urbani E, Carotti A, Aloisi T, Stern M, Pende D, Perruccio K, Burchielli E, Topini F, Bianchi E, Aversa F, Martelli MF, Velardi A. Donor natural killer cell allorecognition of missing self in haploidentical hematopoietic transplantation for acute myeloid leukemia: challenging its predictive value. Blood. 2007 Jul 1;110(1):433-40. doi: 10.1182/blood-2006-07-038687. Epub 2007 Mar 19.
PubMed 17371948
Ciceri F, Labopin M, Aversa F, Rowe JM, Bunjes D, Lewalle P, Nagler A, Di Bartolomeo P, Lacerda JF, Lupo Stanghellini MT, Polge E, Frassoni F, Martelli MF, Rocha V; Acute Leukemia Working Party (ALWP) of European Blood and Marrow Transplant (EBMT) Group. A survey of fully haploidentical hematopoietic stem cell transplantation in adults with high-risk acute leukemia: a risk factor analysis of outcomes for patients in remission at transplantation. Blood. 2008 Nov 1;112(9):3574-81. doi: 10.1182/blood-2008-02-140095. Epub 2008 Jul 7.
PubMed 18606875
Huang XJ, Liu DH, Liu KY, Xu LP, Chen H, Han W, Chen YH, Zhang XH, Lu DP. Treatment of acute leukemia with unmanipulated HLA-mismatched/haploidentical blood and bone marrow transplantation. Biol Blood Marrow Transplant. 2009 Feb;15(2):257-65. doi: 10.1016/j.bbmt.2008.11.025.
PubMed 19167686
Cho BS, Yoon JH, Shin SH, Yahng SA, Lee SE, Eom KS, Kim YJ, Lee S, Min CK, Cho SG, Kim DW, Lee JW, Min WS, Park CW, Kim HJ. Comparison of allogeneic stem cell transplantation from familial-mismatched/haploidentical donors and from unrelated donors in adults with high-risk acute myelogenous leukemia. Biol Blood Marrow Transplant. 2012 Oct;18(10):1552-63. doi: 10.1016/j.bbmt.2012.04.008. Epub 2012 Apr 16.
PubMed 22516055
Cho BS, Min GJ, Park S, Park SS, Shin SH, Yahng SA, Jeon YW, Yoon JH, Lee SE, Eom KS, Kim YJ, Lee S, Min CK, Cho SG, Kim DW, Lee JW, Kim M, Kim Y, Kim HJ. Haploidentical vs matched unrelated donor transplantation for acute myeloid leukemia in remission: A prospective comparative study. Am J Hematol. 2021 Jan;96(1):98-109. doi: 10.1002/ajh.25993. Epub 2020 Nov 24.
PubMed 32905642

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparison of Transplantation From Family-mismatched/Haploidentical Donors With Matched Unrelated Donors in Adult Patients With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT01751997
Acronym / sponsor ID: CBMTC-AML-1
Conditions: Acute Myeloid Leukemia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Byung-Sik ChoUniversity, hospital or other
Study start: Jan 2013 (actual)
Primary completion: 21 May 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 18 Dec 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objectives: Overall survival of FMT may be similar to that of MUT
Secondary objectives:
Comparison of disease-free survival, relapse, non-relapse mortality, immune reconstitution cytomegalovirus infection, and acute or chronic graft-versus-host disease between FMT and MUT. ii. Investigation of possible biomarkers related with above events after transplantation

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Transplants from 8/8-matched unrelated	Active comparator	Drug: Transplants from 8/8-matched Unrelated donorsParticipants will receive transplants from 8/8-matched unrelated donors using myeloablative or reduced-intensity conditioning according to age or comorbidity.
Transplants from family-mismatched/haploidentical donors	Experimental	Drug: Transplants from family-mismatched/haploidentical donorsParticipants will receive FMT using a reduced intensity conditioning regimens.

Who may qualify

Ages: 17 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Patients with AML aged from 18 to 65 years
Eastern Cooperative Oncology Group (ECOG) performance < 2
High risk group for relapse
No HLA-matched sibling and unrelated donor (HLA-A, -B, -C, and -DRB1)
Acceptable organ function defined as serum creatinine < 2 mg/dl, unless considered due to leukemia and serum bilirubin < 3 mg/dl, unless considered due to leukemia

Key exclusion criteria (8 listed)

Active uncontrolled infections
Corrected pulmonary diffusion capacity of <40%
Cardiac ejection fraction of <35%
ECOG performance status :2, 3, 4
Active central nervous system involvement of disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transplants from 8/8-matched Unrelated donors* Myeloablative conditioning 1. Total body irradiation; 165 cGy, every 12 hours, 8 doses, days -7 to -4 (total 1320 cGy) 2. Cyclophosphamide; 60 mg/kg/day, IV for 30 minutes, days -3 to -2 (total 120 mg/kg) 3. Antithymocyte globulin (ATG); 1.25 mg/kg/day, IV for 6 hours, days -3 to -2, (total 2.5 mg/kg) * Reduced-intensity conditioning; older patients (age > 55 years) and/or patients with comorbidities 1. Fludarabine; 30 mg/m^2/day, IV for 1 hour, days -8 to -4 (total 150 mg/m^2) 2. Busulfex; 3.2 mg/kg/day, IV for 3 hours, days -3 to -2 (total 6.4 mg/kg) 3. Total body irradiation; 200 cGy, every 12 hours 2 doses, days -1 (total 400 cGy) 4. ATG; 1.25 mg/kg/day, IV for 6 hours, days -3 to -2, (total 2.5 mg/kg) * GVHD prophylaxis 1. Tacrolimus; 0.03 mg/kg/day, IV for 24 hours from day -1 (0.12 mg/kg/day, PO, if tolerable) 2. Methotrexate; 5 mg/m^2/day, IV push, days +1, +3, +6, +11	Drug	Transplants from 8/8-matched unrelated
Transplants from family-mismatched/haploidentical donors* Reduced-intensity conditioning 1. Total body irradiation; 200 cGy, every 12 hours, 4 doses, days -9 to -8 (total 800 cGy) 2. Fludarabine; 30 mg/m^2/day, IV for 1 hour, days -7 to -3 (total 150 mg/m^2) 3. Busulfex; 3.2 mg/kg/day, IV for 3 hours, days -6 to -5 (total 6.4 mg/kg) 4. ATG; 1.25 mg/kg/day, IV for 6 hours, days -4 to -1 (total 5.0 mg/kg) * GVHD prophylaxis 1. Tacrolimus; 0.03 mg/kg/day, IV for 24 hours from day -1 (0.12 mg/kg/day, PO, if tolerable) 2. Methotrexate; 5 mg/m^2/day, IV push, days +1, +3, +6, +11	Drug	Transplants from family-mismatched/haploidentical donors

Primary outcome

Overall survival
Time frame: annually through 3 years
Overall survival is defined as the time interval between date of enrollment and death from any cause or for surviving patients, to last follow-up

16 secondary outcomes

Neutrophil recovery
Time frame: 56 days
Primary Graft failure
Time frame: 56 days
Secondary Graft failure
Time frame: 100 days
Platelet recovery
Time frame: 100 days and 180 days
Donor cell engraftment
Time frame: 56 days
Acute graft-versus-host disease (aGVHD)
Time frame: every 3 months through 3 years
Chronic graft-versus-host disease (cGVHD)
Time frame: every 3 months through 3 years
Disease free survival
Time frame: annually through year 3
Non-relapse mortality
Time frame: annually through year 3
Infection
Time frame: annually through year 3
WT1 MRD assessment
Time frame: before and 1 month after transplantation, then every 3 months through 3 years
BAALC MRD assessment
Time frame: before and 1 month after transplantation, then every 3 months through 3 years
NGS-based MRD assessment
Time frame: before and 1 month after transplantation, then every 3 months through 3 year
T cells reconstitution
Time frame: before and 2 weeks and 1 month after transplantation, then every 3 months through 1 year
NK cells reconstitution
Time frame: before and 2 weeks and 1 month after transplantation, then every 3 months through 1 year
B cells reconstitution
Time frame: before and 2 weeks and 1 month after transplantation, then every 3 months through 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Background: PubMed 18176612Aversa F. Haploidentical haematopoietic stem cell transplantation for acute leukaemia in adults: experience in Europe and the United States. Bone Marrow Transplant. 2008 Mar;41(5):473-81. doi: 10.1038/sj.bmt.1705966. Epub 2008 Jan 7.
Background: PubMed 20837332Ruggeri A, Ciceri F, Gluckman E, Labopin M, Rocha V; Eurocord and Acute Leukemia Working Party of the European Blood and Marrow Transplant Group. Alternative donors hematopoietic stem cells transplantation for adults with acute myeloid leukemia: Umbilical cord blood or haploidentical donors? Best Pract Res Clin Haematol. 2010 Jun;23(2):207-16. doi: 10.1016/j.beha.2010.06.002.
Background: PubMed 17116940Yakoub-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.
Background: PubMed 3897863Beatty PG, Clift RA, Mickelson EM, Nisperos BB, Flournoy N, Martin PJ, Sanders JE, Stewart P, Buckner CD, Storb R, et al. Marrow transplantation from related donors other than HLA-identical siblings. N Engl J Med. 1985 Sep 26;313(13):765-71. doi: 10.1056/NEJM198509263131301.
Background: PubMed 10155543Anasetti C, Hansen JA. Effect of HLA incompatibility in marrow transplantation from unrelated and HLA-mismatched related donors. Transfus Sci. 1994 Sep;15(3):221-30. doi: 10.1016/0955-3886(94)90134-1.
Background: PubMed 9160695Henslee-Downey PJ, Abhyankar SH, Parrish RS, Pati AR, Godder KT, Neglia WJ, Goon-Johnson KS, Geier SS, Lee CG, Gee AP. Use of partially mismatched related donors extends access to allogeneic marrow transplant. Blood. 1997 May 15;89(10):3864-72.
Background: PubMed 15753458Aversa F, Terenzi A, Tabilio A, Falzetti F, Carotti A, Ballanti S, Felicini R, Falcinelli F, Velardi A, Ruggeri L, Aloisi T, Saab JP, Santucci A, Perruccio K, Martelli MP, Mecucci C, Reisner Y, Martelli MF. Full haplotype-mismatched hematopoietic stem-cell transplantation: a phase II study in patients with acute leukemia at high risk of relapse. J Clin Oncol. 2005 May 20;23(15):3447-54. doi: 10.1200/JCO.2005.09.117. Epub 2005 Mar 7.
Background: PubMed 17371948Ruggeri L, Mancusi A, Capanni M, Urbani E, Carotti A, Aloisi T, Stern M, Pende D, Perruccio K, Burchielli E, Topini F, Bianchi E, Aversa F, Martelli MF, Velardi A. Donor natural killer cell allorecognition of missing self in haploidentical hematopoietic transplantation for acute myeloid leukemia: challenging its predictive value. Blood. 2007 Jul 1;110(1):433-40. doi: 10.1182/blood-2006-07-038687. Epub 2007 Mar 19.
Background: PubMed 18606875Ciceri F, Labopin M, Aversa F, Rowe JM, Bunjes D, Lewalle P, Nagler A, Di Bartolomeo P, Lacerda JF, Lupo Stanghellini MT, Polge E, Frassoni F, Martelli MF, Rocha V; Acute Leukemia Working Party (ALWP) of European Blood and Marrow Transplant (EBMT) Group. A survey of fully haploidentical hematopoietic stem cell transplantation in adults with high-risk acute leukemia: a risk factor analysis of outcomes for patients in remission at transplantation. Blood. 2008 Nov 1;112(9):3574-81. doi: 10.1182/blood-2008-02-140095. Epub 2008 Jul 7.
Background: PubMed 19167686Huang XJ, Liu DH, Liu KY, Xu LP, Chen H, Han W, Chen YH, Zhang XH, Lu DP. Treatment of acute leukemia with unmanipulated HLA-mismatched/haploidentical blood and bone marrow transplantation. Biol Blood Marrow Transplant. 2009 Feb;15(2):257-65. doi: 10.1016/j.bbmt.2008.11.025.
Background: PubMed 22516055Cho BS, Yoon JH, Shin SH, Yahng SA, Lee SE, Eom KS, Kim YJ, Lee S, Min CK, Cho SG, Kim DW, Lee JW, Min WS, Park CW, Kim HJ. Comparison of allogeneic stem cell transplantation from familial-mismatched/haploidentical donors and from unrelated donors in adults with high-risk acute myelogenous leukemia. Biol Blood Marrow Transplant. 2012 Oct;18(10):1552-63. doi: 10.1016/j.bbmt.2012.04.008. Epub 2012 Apr 16.
Derived from this study: PubMed 32905642Cho BS, Min GJ, Park S, Park SS, Shin SH, Yahng SA, Jeon YW, Yoon JH, Lee SE, Eom KS, Kim YJ, Lee S, Min CK, Cho SG, Kim DW, Lee JW, Kim M, Kim Y, Kim HJ. Haploidentical vs matched unrelated donor transplantation for acute myeloid leukemia in remission: A prospective comparative study. Am J Hematol. 2021 Jan;96(1):98-109. doi: 10.1002/ajh.25993. Epub 2020 Nov 24.

Related trials for Acute Myeloid Leukemia

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hee-Je Kim, MD, PhD principal investigator

Seoul St. Mary's Hematology Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall survival (time frame: annually through 3 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 NCT01751997, which also lists 12 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 19 Apr 2024.