VPA Expanded UCB Transplantation for Treatment of Patients With Hematological Malignancies

Completed · Phase 1

Conditions studied: Hematological Malignancy, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia in Remission, Myelodysplastic Syndromes, Non-Hodgkin Lymphoma, Hodgkin Lymphoma

In brief

In this Phase I study, the study team will evaluate the safety of Valproic Acid (VPA) expanded cord blood stem cells defined by the lack of serious infusion reactions or graft failure in patients with hematological malignancies undergoing umbilical cord blood transplantation. Moreover, the study team will also evaluate time to neutrophil and platelet engraftment as well as transplant related outcomes such as graft versus host disease (GVHD), treatment related mortality (TRM), and overall survival (OS).

Key facts

Study ID

NCT03885947

Run by

Alla Keyzner

People needed

7

Starts

2019-02-21

Expected to finish

2021-03-10

Last updated by the study team

2021-05-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Disease criteria:
• Patients with the following hematological malignancies:
• Acute Myeloid Leukemia (AML) in complete remission (CR)
• Acute Lymphoblastic Leukemia (ALL) in complete remission (CR)
• Myelodysplastic Syndrome (MDS) requiring intensive chemotherapy
• Non-Hodgkin lymphoma in complete or partial remission
• Hodgkin lymphoma in complete or partial remission
• Age Criteria:
• 18 years up to 65 years.
• Organ Function and Performance Status Criteria:
• Performance status score: Karnofsky Score ≥60
• Adequate major organ function defined as:
• Left ventricular ejection fraction ≥40%
• Pulmonary function test demonstrating DLCO ≥50% predicted and corrected for hemoglobin
• Serum creatinine ≤ 2 mg/dL
• Transaminases ≤ 3x ULN
• Bilirubin ≤3x ULN except for in case of Gilbert's syndrome or ongoing hemolysis
• Ability to understand and the willingness to sign a written informed consent document
• Donor availability:
• Lack of suitable HLA matched related or unrelated donor available within 30 days or less if BMT is urgent in the opinion of the transplant physician.

You may not qualify if…

• Progressive, persistent disease or active malignancy
• Greater than 10% blasts on bone marrow biopsy in patients with MDS
• Chemotherapy naïve
• History of myelofibrosis
• Presence of Bone Marrow Fibrosis grade 2/3
• Presence of donor specific anti-HLA antibodies against available UCB units at A, B, C or DR loci, with a mean fluorescence intensity (MFI)>1000
• History of prior allogeneic stem cell transplantation
• Uncontrolled viral, bacterial or fungal infection
• History of HIV infection
• Presence of active CNS disease at the time of transplantation
• Pregnant or breastfeeding female
• Inability or unwillingness to use effective birth control.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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