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A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Post - Remission Therapy for High Risk Leukemia or Myelodysplasia.
|Leukemia, Acute Lymphoblastic (ALL)
|Leukemia, Acute Myeloid (AML)
|Leukemia, Chronic Myeloid (CML)
|Myelodysplastic Syndrome (MDS)
- Primary Objective
- The primary objective of the study is to determine the safety and tolerability of CLT-008 in patients receiving post-remission therapy for high risk acute leukemia (ALL/AML), CML or myelodysplasia (MDS)
- Secondary Objectives
- The secondary objectives related to assessment of CLT-008 activity are to evaluate:
- Time to neutrophil recovery
- Duration of severe neutropenia
- Duration of severe thrombocytopenia
- Duration of G-CSF administration
- CLT-008 engraftment by molecular chimerism analysis
- Incidence, severity and duration of mucositis
- Days of fever and incidence of infections
- Duration of antibiotic use
- Incidence and duration of hospitalization
- The secondary objectives related to assessment of CLT-008 safety are to evaluate:
- Overall frequency and severity of adverse events
- CLT-008 infusion reactions
- Graft-vs-Host Disease (GVHD)
- Failure of autologous neutrophil recovery
- New onset of platelet refractoriness and induction of anti-HLA antibodies
- Deaths on study
- At least 18 years of age
- Planned treatment with intermediate or high-dose cytarabine-based consolidation chemotherapy regimen of not more than 5 days duration
- High risk acute leukemia or MDS as determined by age, remission/relapse history, molecular or cytogenetic criteria:
- AML: a) ≥60 years of age, or b) prior relapse - in second or subsequent CR (CR2+), or c) required 2 or more cycles of induction to achieve CR1, or d) in CR1 and not considered "good risk" as defined under exclusion criterion #1.
- ALL: a) "high" risk CR1: i) high risk cytogenetics [t(9;22) or other bcr-abl rearrangements, t (1:19), t(4;11) or other MLL rearrangements]; or ii) required 2 or more cycles of induction to achieve CR1, or b) prior relapse - in second or subsequent CR (CR2+)
- CML: a) Late accelerated phase or blast crisis after achieving second or subsequent chronic phase
- MDS: a) "high" risk CR1: defined by IPSS score ≥ 2.5, or b) prior relapse - in second or subsequent CR (CR2+)
- In complete remission (CR), or second or subsequent chronic phase in the case of CML, as defined by hematological criteria (e.g. <5% blasts by light microscopy with a marrow cellularity of ≥15%).
- ECOG performance status of 0 -2
- Laboratory test findings:
- Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper institutional limits of normal (ULN), ALT and AST ≤ 2.5 x ULN. Patients with a history of Gilbert’s syndrome may be enrolled if the total bilirubin is < 3 mg/dL with an indirect bilirubin of ≥ 1.5 mg/dL.
- Adequate renal function with serum creatinine ≤ 1.5 x ULN.
- Adequate hematologic function with absolute neutrophil counts ≥ 1,000 cell/mm³, platelets ≥ 75,000 cells/mm³ and hemoglobin value ≥ 7 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value ≥ 7 g/dL with blood transfusions are allowed).
- Adequate cardiac function with left ventricular ejection fraction > 45%.
- Adequate respiratory function with a room air oxygen saturation of at least 92%.
- Adequately informed of the nature and risks of the study with written informed consent given prior to receiving any study medication.
- AML patients in first remission (CR1) under the age of 60 will be considered "good risk" and excluded if they have:
- promyelocytic leukemia t(15;17), or
- isolated t(8;21), or
- isolated inv(16), or
- isolated t(16;16), or
- normal conventional cytogenetics with: i) NPM1 mutation in absence of FLT3-ITD, or ii) isolated homozygous CEBPA mutation in absence of FLT3-ITD
- Prior allograft within 3 years of study registration
- Prior history of active GVHD within 3 years of study registration
- Planned donor lymphocyte infusion prior to Study Day 49
- Planned human cell transplant before Study Day 49
- Planned autologous stem cell harvesting before Study Day 49
- Received an investigational leukemia therapy within 30 days prior to enrollment
- Received prior treatment with CLT-008
- Pregnant or breastfeeding.
- Any condition which could interfere with, or for which the treatment might interfere with, the conduct of the study, or which would, in the opinion of the Investigator, unacceptably increase the risk of the patient’s participation in the study.
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