TXA127 in Enhancement of Engraftment in Adult Double Cord Blood Transplantation

Stopped early · Phase 1

Conditions studied: Double Cord Blood Transplant, Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Myelofibrosis, Acute Lymphoblastic Leukemia, Chronic Myelocytic Leukemia, Non Hodgkins Lymphoma, Hodgkins Lymphoma, Chronic Lymphocytic Leukemia

In brief

The purpose of this study is to evaluate the effect of TXA127 on neutrophil and platelet counts in adult patients who have undergone a double cord blood transplant. The study will also evaluate the effect of TXA127 on chemotherapy-induced mucositis, an inflammation of the mucous membranes in the digestive tract (mouth to anus) and immune reconstitution which helps patients fight infections. For patients undergoing CBT, both neutrophil and platelet normalization and immune reconstitution can be delayed. TXA127 has shown to be well tolerated by patients and appears to induce a rapid production of neutrophils and platelets in the bloodstream as well as increase the immune system components. It has also been shown to reduce the severity of chemotherapy-induced mucositis.

Key facts

Study ID: NCT01300611
Run by: Tarix Pharmaceuticals
People needed: 20
Starts: 2011-01-01
Expected to finish: 2020-12-01
Last updated by the study team: 2020-12-08

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects with Acute Myelogenous Leukemia (AML) past first remission, in first or subsequent relapse, induction failure, or in first remission with high-risk for relapse (with high-risk cytogenetics or presence of flt3 mutation or secondary leukemia from prior chemotherapy)
Myelodysplastic Syndrome or Myelofibrosis of intermediate or high-risk
Acute Lymphoblastic Leukemia (ALL): Induction failure, fist complete remission with Philadelphia chromosome or translocation (4:11), hypodiploidy and or evidence of minimal residual disease by flow cytometry, second or third complete remission or second relapse
Chronic Myelocytic leukemia (CML): Second chronic phase or accelerated phase
Non-Hodgkin's Lymphoma (NHL): Induction failures, second or third complete remission or relapse
Hodgkin's Lymphoma (HL): Induction failures, second or third complete remission or relapse
Chronic Lymphocytic leukemia (CLL): Progressive disease following standard therapy
Other hematologic malignancies which meet investigational site standards for cord blood transplant
Subjects must be at least 18 years of age
Subjects must have ECOG status of ≤ 2
Subjects with bone marrow blasts ≤ 10%
Subjects must have adequate major organ function
Male and Female Subjects capable of reproduction must agree to use contraceptive methods during the course of the study and for 2 months following the last administration of study drug
Cord blood requirements: a) Unrelated CB will be used as a source of hematopoietic support if a 7/8 or 8/8 related or 8/8 unrelated bone marrow donor is not available, or if the tempo of the subject's disease dictates it is not in the subject's best interest to wait for an unrelated marrow donor to be procured. b) Subjects must have two CB units available which are matched with the subject at 4/6, 5/6, or 6/6 HLA class I (serological) and II (molecular) antigens. Each unit must contain at least 1 x 10\^7 total nucleated cells/kg recipient body weight (pre-thaw).

You may not qualify if…

Subjects who received antineoplastic treatment including chemotherapy, immunotherapy and radiation therapy ≤ 2 weeks prior to Screening Period
Subjects who underwent prior total body irradiation
Subjects who received prior allogeneic hematopoietic cell transplants
Subjects seropositive for HIV, Hepatitis B or Hepatitis C
Female subjects who are pregnant or breastfeeding
Subjects who have received an investigational drug within 30 days of projected first administration of study drug (Day 0)
Subjects with current alcohol use, illicit drug use, or any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule
Subjects with known hypersensitivity to TXA127
Subjects with uncontrolled medical or psychiatric condition which would limit informed consent
Subjects with a willing and appropriate HLA-matched related marrow donor

Where it is running

MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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