CRI - Acute Myeloid Leukemia (AML) and Myelodyplastic Syndromes (MDS)
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DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndomes-Government clinical trial
This is a Phase I/II, open-label, dose escalation, multi-dose study of therapy targeting the Interleukin-3 Receptor (IL3R) for patients with relapsed or refractory and ederly or poor-risk Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome with DT388IL3 (IND# 11314) Clinical Trial. DT388IL3 is an immunotoxin targeting the IL3 receptor found on leukemia cells.
DT388IL3 is to be given as a daily infusion for five days. It is anticipated that approximately 40 patients will be enrolled in this study over a period of three years.
Patients will receive full supportive care including transfusions of blood and blood products, antibiotics, fluids, electrolytes, antiemetics (not to include corticosteroids) etc. when appropriate. However, patients are not allowed hematopoietic growth factors, intravenous immunoglobulins, other anti-neoplastic drugs or radiation therapy during the study. Patients will be hospitalized for approximately one week for the completion of the five daily doses of fifteen minute IV infusions of DT388IL3. Patients initially will have follow-up at least weekly with blood work and clinic visits. Bone marrow aspirates and biopsies will be done in follow-up on days 15 and 30 for all patients. Patients who achieve remission will be followed monthly with blood work and every three months with bone marrows until relapse or progression.
- At least 18 years old
- Relapsed, refractory or poor-risk AML or high-risk MDS
- Blast marrow index ≤ 40
- Not eligible for or willing to undergo a bone marrow or stem cell transplant
- Adequate cardiac function
- Adequate liver function
- Adequate kidney function
- No serious concurrent medical conditions, CNS disease, uncontrolled infections, heart attack in the last six months, or disseminated intravascular coagulopathy (DIC)
- Willing to use an approved form of birth control while on study and for two weeks after completion