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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02428517
Other study ID # AMC-ALLO-044
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 2015
Est. completion date July 2016

Study information

Verified date July 2018
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 complete remission (CR).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria:

- 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)

- 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.

Exclusion Criteria:

- 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
AlloHCT for Young/MSD
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&FMD
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/MSD
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&FMD
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)

Locations

Country Name City State
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Asan Medical Center, University of Ulsan College of Medicine Seoul
Korea, Republic of Ulsan University Hospital, University of Ulsan College of Medicine Ulsan

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (37)

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Kanda Y, Oshima K, Asano-Mori Y, Kandabashi K, Nakagawa M, Sakata-Yanagimoto M, Izutsu K, Hangaishi A, Tsujino S, Ogawa S, Motokura T, Chiba S, Hirai H. In vivo alemtuzumab enables haploidentical human leukocyte antigen-mismatched hematopoietic stem-cell transplantation without ex vivo graft manipulation. Transplantation. 2005 May 27;79(10):1351-7. — View Citation

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* Note: There are 37 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary relapse-free survival (RFS) rate time from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse 2 years
Secondary relapse-free survival (RFS) rate time from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse 5 years
Secondary overall survival (OS) rate time from the diagnosis of disease to death/ time from the enrollment of this trial to death 2 years
Secondary overall survival (OS) rate time from the diagnosis of disease to death/ time from the enrollment of this trial to death 5 years
Secondary cumulative incidence of relapse from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse 2 years
Secondary cumulative incidence of relapse from achieving hematologic CR to hematologic relapse / time from the enrollment of this trial to hematologic relapse 5 years
Secondary treatment-related mortality rate after enrollment of this trial 100 days
Secondary treatment-related mortality rate after enrollment of this trial 1 year
Secondary treatment-related mortality rate after enrollment of this trial 2 years
Secondary treatment-related mortality rate after enrollment of this trial 5 years
Secondary cumulative incidence of acute graft-versus-host disease after enrollment of this trial 100 days
Secondary cumulative incidence of acute graft-versus-host disease after enrollment of this trial 1 year
Secondary cumulative incidence of acute graft-versus-host disease after enrollment of this trial 2 years
Secondary cumulative incidence of acute graft-versus-host disease after enrollment of this trial 5 years
Secondary cumulative incidence of chronic graft-versus-host disease after enrollment of this trial 100 days
Secondary cumulative incidence of chronic graft-versus-host disease after enrollment of this trial 1 year
Secondary cumulative incidence of chronic graft-versus-host disease after enrollment of this trial 2 years
Secondary cumulative incidence of chronic graft-versus-host disease after enrollment of this trial 5 years
Secondary molecular relapse-free survival after enrollment of this trial / after achieving molecular CR (for Ph-positive ALL) 2 years
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