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Phase I Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Adults Undergoing Double Cord Blood Transplantation

Phase 1
18 Years
60 Years
Open (Enrolling)
Double Cord Blood Transplant, Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Myelofibrosis, Acute Lymphoblastic Leukemia, Chronic Myelocytic Leukemia, Non Hodgkins Lymphoma, Hodgkins Lymphoma, Chronic Lymphocytic Leukemia

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Trial Information

Phase I Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Adults Undergoing Double Cord Blood Transplantation

Cord blood as a hematopoietic stem cell source has multiple advantages. Cord blood is
normally discarded at birth and can easily be collected and stored. Availability of numerous
CB banks has resulted in genetically diverse CB units including those from non-Caucasians.
Once a suitable CB unit is located, confirmatory typing can be quickly performed and a donor
unit can be shipped to the transplant center. Furthermore, because a CB graft results in a
lower incidence of graft-versus-host-disease, one or two antigen-mismatched units are
acceptable for transplantation. Despite these advantages, CB has a significant drawback
which is that the number of hematopoietic stem cells obtained from a unit of CB is
significantly lower than from a bone marrow (BM) harvest or peripheral blood stem cell
(PBSC) harvest. Both engraftment and immune reconstitution are delayed in patients
undergoing CB transplant. TXA127 is pharmaceutically-formulated angiotensin 1-7, a
non-hypertensive derivative of angiotensin II (which contains the 8th amino acid conferring
receptor binding to blood pressure receptors). TXA127 has multilineage effects on
hematopoietic progenitors in vitro and in vivo. The hematopoietic properties demonstrated in
preclinical and clinical studies support the investigation of TXA127 to reduce time to
neutrophil and platelet engraftment following transfusion of limited number of CD34+ cells.

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

- 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).

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Description:

The safety and tolerability profile of TXA127 will be provided by descriptively summarizing, at a minimum, the following outcomes: 1) number and proportion of patients with adverse events presented by preferred term, by system organ class (SOC), and by severity grade and relationship to TXA127, as assessed by the Investigator; 2) number and proportion of patients terminating TXA127 due to adverse events related to TXA127; 3) Day 100 treatment-related mortality (TRM) rate; 4) Day 100 mortality rate; 5) number of red blood cell and other blood component transfusions; 6) incidence of infection.

Outcome Time Frame:

100 days post-transplantation

Safety Issue:


Principal Investigator

Uday R Popat, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

September 2013

Related Keywords:

  • Double Cord Blood Transplant
  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Myelofibrosis
  • Acute Lymphoblastic Leukemia
  • Chronic Myelocytic Leukemia
  • Non Hodgkins Lymphoma
  • Hodgkins Lymphoma
  • Chronic Lymphocytic Leukemia
  • Double Cord Blood Transplantation
  • Neutrophil Engraftment
  • Platelet Engraftment
  • Immune Reconstitution
  • Mucositis
  • Primary Myelofibrosis
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia



MD Anderson Cancer Center Houston, Texas  77030-4096