TerminatedPhase 1

TXA127 in Enhancement of Engraftment in Adult Double Cord Blood Transplantation

United States20 participantsStarted 2011-01

Plain-language summary

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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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…

What they're measuring

Safety of TXA127 (Angiotensin 1-7) in subjects undergoing double cord blood transplantation

Timeframe: 100 days post-transplantation

Trial details

NCT IDNCT01300611

SponsorTarix Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12