Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation

Myelodysplastic Syndrome Clinical Trial

— RICandDLI  

Official title:

Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01252784
• Other study ID #: Allo-039
• Status: Recruiting
• Phase: Phase 2
• First received: December 1, 2010
• Last updated: December 1, 2010
• Start date: November 2010
• Est. completion date: October 2014

Study information

• Verified date: November 2010
• Source: Cooperative Study Group A for Hematology
• Contact: Je-Hwan Lee, Doctor
• Phone: 82-2-3010-3218
• Email: jhlee3[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.

Description:

Conditioning therapy

• Busulfan 3.2 mg/kg/d on d-7 to -6

• Fludarabine 30 mg/m2 on d-7 to -2

• ATG 1.5-3.0 mg/kg/d on d-3 to -1

• Methylpred 2 mg/kg/d on d-4 to -1

Mobilization and harvest

• Donor

• G-CSF 10 mcg/kg/d s.c. on d-3 to 0

• Harvest of PBMCs on d 0 to +1

Infuse G-PBMCs on d 0 to d+1.

• Donor G-PBMC infusion

GVHD prophylaxis

• Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60.

• Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7

Prophylactic dose-escalating DLIs

• Begin at d+120 or at least 2 wks after IST discontinuation.

• No evidence of recurrence or GVHD CD3+ cell dose increment q 4 wks 4Three dose levels

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Patients with higher risk MDS including chronic myelomonocytic leukemia

• RAEB-1 or RAEB-2

• IPSS Intermediate-2 or High risk category

• Chronic myelomonocytic leukemia

2. Patients with appropriate hematopoietic cell donor

• HLA-matched sibling

• HLA-matched unrelated donor

• HLA-mismatched familial donor 3.16 years old or older

Exclusion Criteria:

• • Presence of significant active infection

• Presence of uncontrolled bleeding

• Any coexisting major illness or organ failure

• Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Asanbyeongwon-gil, songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Study Group A for Hematology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse incidence,duration of remission	The efficacy of the treatment will be measured in terms of relapse incidence and duration of remission (the primary endpoints). The hematopoietic cell donors in the study will include HLA-matched sibling, HLA-matched unrelated donors, and HLA-mismatched familial donors.	4years	Yes
Secondary	engraftment, donor chimerism, secondary graft failure,GVHD	•This study will evaluate engraftment, donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, non-relapse mortality, progression-free survival (PFS), and OS.	4 years	Yes

External Links

•   Reduced-intensity conditioning allogeneic hematopoietic cell transplantation followed by prophylactic dose-escalating donor lymphocyte infusions in higher risk myelodysplastic syndrome