TXA127 in Enhancement of Engraftment in Adult Double Cord Blood Transplantation (USBTXA127CBT)
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ClinicalTrials.gov Identifier: NCT01300611 |
Recruitment Status :
Terminated
First Posted : February 21, 2011
Last Update Posted : December 8, 2020
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Condition or disease | Intervention/treatment | Phase |
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Double Cord Blood Transplant Acute Myelogenous Leukemia Myelodysplastic Syndrome Myelofibrosis Acute Lymphoblastic Leukemia Chronic Myelocytic Leukemia Non Hodgkins Lymphoma Hodgkins Lymphoma Chronic Lymphocytic Leukemia | Drug: TXA127 300 mcg/kg/day Drug: TXA127 1000 mcg/kg/day | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Phase I Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Adults Undergoing Double Cord Blood Transplantation |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | December 2020 |
Actual Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
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Experimental: TXA127 300 mcg/kg/day
Treatment group 1 (300 mcg/kg/day) of a two-arm, dose-escalation pilot feasibility trial of TXA127 (Angiotensin 1-7) in subjects undergoing double cord blood transplantation for the treatment of a variety of hematologic malignancies for whom there is no available therapy with substantive anti-disease effect.
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Drug: TXA127 300 mcg/kg/day
Injection, 300 mcg/kg/day for 28 days |
Experimental: TXA127 1000 mcg/kg/day
Treatment group 2 (1000 mcg/kg/day) of a two-arm, dose-escalation pilot feasibility trial of TXA127 (Angiotensin 1-7) in subjects undergoing double cord blood transplantation for the treatment of a variety of hematologic malignancies for whom there is no available therapy with substantive anti-disease effect.
|
Drug: TXA127 1000 mcg/kg/day
Injection, 1000 mcg/kg/day for 28 days |
- Safety of TXA127 (Angiotensin 1-7) in subjects undergoing double cord blood transplantation [ Time Frame: 100 days post-transplantation ]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.
- Platelet transfusion requirements [ Time Frame: 100 days post-transplantation ]Platelet transfusion requirements based on units of platelets transfused and days of platelet transfusions
- Immune reconstitution [ Time Frame: 100 days post-transplantation ]Immune reconstitution will be assessed via the measurement of peripheral blood concentrations of CD3+, CD4+, CD8+, CD19+, and CD56+ cells (performed at Study Days 62 and 100).
- Incidence, duration, and severity grade of mucositis [ Time Frame: 100 days post-transplantation ]Incidence of mucositis is defined by the occurrence of least one adverse event with MedDRA preferred term that includes "mucositis" or "stomatitis". The severity grade will be determined by NCI-CTCAE.
- Incidence, duration, and severity grade of acute graft-vs-host-disease (aGVHD) [ Time Frame: 100 days post-transplantation ]Incidence, severity and duration of aGVHD will be reported as a proportion (with 95% CIs) of subjects with Grade II-IV aGVHD. All incidents of aGVHD will at a minimum be listed, with the severity and time course included.
- Time to engraftment/recovery [ Time Frame: 100 days post-transplantation ]Time to neutrophil engraftment and platelet recovery

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300611
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Uday R Popat, MD | M.D. Anderson Cancer Center |
Responsible Party: | Tarix Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01300611 |
Obsolete Identifiers: | NCT01302678 |
Other Study ID Numbers: |
TXA127-2010-001 |
First Posted: | February 21, 2011 Key Record Dates |
Last Update Posted: | December 8, 2020 |
Last Verified: | December 2020 |
Double Cord Blood Transplantation Neutrophil Engraftment Platelet Engraftment Immune Reconstitution Mucositis |
Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Hematologic Diseases Leukemia, Lymphoid Leukemia, B-Cell Myeloproliferative Disorders |