Phase
Condition
Leukemia
Myelodysplastic Syndromes (Mds)
White Cell Disorders
Treatment
N/AClinical Study ID
Ages 8-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Myelodysplastic syndrome with excess blasts: Cytopenias, Unilineage or multilineagedysplasia, 5-19% blasts in bone marrow.
Acute lymphocytic leukemia or acute myelogenous leukemia who are in first remission orsecond remission.
Karnofsky performance status (KPS) >= 70%
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry andfor six months following duration of study participation; should a woman becomepregnant or suspect that she is pregnant while participating on the trial, she shouldinform her treating physician immediately
All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR)identical siblings who is willing to donate primed blood stem cells or a 10/10 allelematched unrelated donor; a single allele mismatch at A, B, C, DR or DQ and a killerimmunoglobulin-like receptor (KIR) mismatch at C will be allowed; all ABO blood groupcombinations of the donor/recipient are acceptable since even major ABOcompatibilities can be dealt with by various techniques (red cell exchange or plasmaexchange)
A cardiac evaluation with an electrocardiogram showing no ischemic changes or abnormalrhythm and an ejection fraction of >= 50% established by multi gated acquisition scan (MUGA) or echocardiogram
Patients must have a serum creatinine of less than or equal to 1.3 mg/dL or creatinineclearance > 80 ml/min
Hepatic: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT),Alkaline phosphatase (ALP) < 5 x upper limit of normal (ULN)
Pulmonary function: Carbon Monoxide Diffusing Capacity corrected (DLCOcorr) > 50% ofnormal, (oxygen saturation [>92%] can be used in child where pulmonary function tests (PFT's) cannot be obtained)
The time from the end last induction or re-induction attempt should be greater than orequal to 14 days
All subjects must have the ability to understand and the willingness to sign a writteninformed consent
Exclusion
Exclusion Criteria:
Diagnosed extramedullary leukemia
Active uncontrolled infection at time of enrollment or documented fungal infectionwithin 3 months.
Evidence of Human immunodeficiency virus (HIV) infection
Prior myeloablative transplant within the last 6 months
Prior radiation therapy that would exclude the use of TMLI
Relapsed patients who have undergone autologous or allogeneic hematopoietic stem celltransplantation previously
Study Design
Study Description
Connect with a study center
Affiliated Hospital to Academy of Military Medical Sciences (307 Hospital of PLA)
Beijing, Beijing 100071
ChinaActive - Recruiting
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