NL-OMON53840尚未招募2 期
A PHASE II OPEN-LABEL STUDY OF UM171-EXPANDED CORD BLOOD TRANSPLANTATION IN PATIENTS WITH HIGH AND VERY HIGH-RISK ACUTE LEUKEMIA/MYELODYSPLASIA. - ECT-001-CB Expanded Cord Blood Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Age 18 to 65 years old
- •2) Presence of a high and very high-risk hematologic malignancy defined as:
- •a. Acute Myeloid Leukemia:
- •i. Primary induction failure (no CR or CRi after >= 2 courses of intensive
- •induction therapy or after >= 1 induction containing high dose Ara-C)
- •ii. Chemorefractory relapse (no CR or CRi after 1 chemointensive treatment)
- •iii. Relapse after allogeneic or autologous transplant.
- •iv. High risk AML in CR1 as defined by European Leukemia Net (ELN)
- •v. >= CR2
- •vi. Presence of minimal residual disease at the time of transplant63
- •b. Acute Lymphoid leukemia
- •i. Primary induction failure (>= 2 inductions)
- •ii. High risk ALL in CR1: Ph like ALL or any other poor risk feature
- •iii. >= CR2
- •iv. Chemorefractory relapse (at least 1 intensive induction chemotherapy)
- •v. Relapse after allogeneic or autologous transplant
- •vi. Presence of minimal residual disease at the time of transplant
- •c. Myelodysplastic syndrome (MDS):
- •i. Relapse after allogeneic or autologous transplant
- •ii. >=10 % blasts within 30 days of start of conditioning regimen
- •iii. Poor and very poor cytogenetics abnormalities
- •iv. CMML with HCT-specific CPSS score high or intermediate-264,65
- •v. Stable disease (absence of CR/PR/HI) after 6 cycles of azacitidine (or
- •another demethylating agent) 66,67.
- •vi. Progressive disease while on azacitidine (or another demethylating
- •agent)66-68.
- •d. Chronic myelogenous leukemia: Patients who have progressed to blast crisis.
- •3) Availability of 2 UCBs >= 4/6 HLA match when DRB1 is performed at the allele
- •level and A, B at antigen resolution (intermediate resolution) and >= 4/8 HLA
- •match when A, B, C and DRB1 are performed at the allele level. An acceptable
- •alternative would be a 3/6 or 5/8 as long as there is no double DRB1 mismatch.
- •a. Selection of cord to be expanded:
- •i. Pre-freeze CD34+ cell count >=0.5 x 105/kg and TNC>=1.5 x 107/kg
- •ii. Needs to be erythrodepleted by bank prior to cryopreservation
- •iii. Must come from a cord bank that is FACT or AABB accredited, FDA approved
- •or eligible for NMDP IND (unless PI approves another bank).
- •b. Selection of non-expanded CB/back-up cord:
- •i. Pre-freeze CD34+ cells >=1.5 x 105/kg with TNC count >= 2.0 x 107/kg or,
- •ii. Pre-freeze CD34+ cells >=1.7 x 105/kg with TNC count >=1.5 x 107 kg.
- •iii. If a single cord does not meet these criteria, 2 back up cords will be an
- •acceptable alternative with each having CD34+ cells >1 x 105/kg with TNC>1.5 x
- •iv. Must come from a cord bank that is FACT or AABB accredited, FDA approved or
- •eligible for NMDP IND (unless PI approves another bank).
- •4) Karnofsky >=70.
- •5) Left ventricular ejection fraction >= 40% (within 3 months unless the patient
- •has received chemotherapy or radiation therapy to the thorax since the last
- •cardiac evaluation) OR fractional shortening >22%
- •6) Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and
- •diffusing capacity corrected for hemoglobin (DLCOc) >= 50% of predicted
- •7) Bilirubin < 2 x upper limit of normal (ULN) unless felt to be related to
- 另有 3 项未显示
排除标准
- •1) Allogeneic myeloablative transplant within 6 months.
- •2) Autologous hematopoietic stem cell transplant within 6 months.
- •3) Active or recent (prior 6 months) invasive fungal infection without ID
- •consult and approval.
- •4) The presence of a malignancy other than the one for which the UCB transplant
- •is being performed and the expected survival related to the malignancy is
- •estimated to be less than 75% at 5 years.
- •5) HIV positivity.
- •6) Hepatitis B or C infection with measurable viral load.
- •7) Liver cirrhosis.
- •8) Pregnancy, breastfeeding or unwillingness to use appropriate contraception.
- •9) Participation in a trial with an investigational agent within 30 days prior
- •to entry in the study.
研究者
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