Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia

Leukemia, Myelomonocytic, Acute Clinical Trial

Official title:

Application of Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04687657
• Other study ID #: XJTU1AF-CRF-2020-016
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: huaiyu Wang, doctor
• Phone: 0086-18991232410
• Email: whymed[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After complete remission, elderly AML patients cannot tolerate hematopoietic stem cell transplantation and standard-dose consolidation chemotherapy, and the 5-year survival rate is around 10%. Therefore, it is necessary to explore treatment strategy that can support chemotherapy or improve immunity. Umbilical cord blood is rich in hematopoietic stem cells and immune cells. However,Cord blood transplantation for adults is still being explored. The application of cord blood in supportive treatment can be actively explored. Cord blood has low immunogenicity and is unlikely to cause Graft versus host disease (GVHD), and the infusion is relatively safe. The Department of Hematology of Shanghai Ruijin Hospital has conducted a related phase II clinical study, and found that cord blood transfusion reduced the chance of infection and increased the 2-year survival. Our subject is a prospective single-arm clinical study. It is planned to recruit 20 elderly AML patients to explore whether the application of cord blood infusion can further improve the prognosis of patients during their consolidation chemotherapy.

Description:

20 elderly AML patients who achieved complete remission (CR) after induction chemotherapy will be enrolled in this study. Baseline data are collected and informed consents are signed before consolidation chemotherapy. At the same time, HLA typing test is carried out, and the corresponding cord blood is matched from the cord blood bank. During the consolidation chemotherapy stage, the cord blood transfusion is given twice (interval of 1 month) to support treatment. On the first day after umbilical cord blood transfusion, the proportion of NK cells in peripheral blood are detected. If it is less than 20%, the NK cells are activated by subcutaneous injection of recombinant human interleukin-2 (rhIL-2) on the second day after infusion. The treatment effects are continuously monitored and followed up regularly after treatment.The intend of this trial is to explore whether cord blood transfusion in the consolidation phase can further reduce the recurrence rate of AML and improve prognosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age =60 years

• Patients with primary AML diagnosed in accordance with the "Adult Acute Myeloid Leukemia (Non-Acute Promyelocytic Leukemia) Chinese Diagnosis and Treatment Guidelines (2017 Edition)", who achieved CR after induction chemotherapy

• Normal heart function , Ejection fraction = 50%

• Normal liver function with ALT and AST = 2.5 times the upper limit of normal value, bilirubin = 2 times the upper limit of normal value

• Normal kidney function with blood creatinine = 3.0 mg/dL (= 260 µmol/L)

• Voluntarily signed an informed consent.

Exclusion Criteria:

• Combined with severe infection

• Combined with other malignant tumors

• Other patients deemed unsuitable to be tested by the investigator

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Acute

Intervention

Drug:
• umbilical cord blood
During the consolidation chemotherapy stage, the umbilical cord blood transfusion is given twice (interval of 1 month) to support treatment. On the first day after umbilical cord blood transfusion, the proportion of NK cells in peripheral blood is detected. If it is less than 20%, the NK cells sre activated by subcutaneous injection of recombinant human interleukin-2 (rhIL-2) on the second day after infusion.

Locations

Country	Name	City	State
China	The first affiliated hospital of Xi'an jiaotong university	Xi'an	Shanxi
China	Xi'anJiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (6)

Ballen KK, Gluckman E, Broxmeyer HE. Umbilical cord blood transplantation: the first 25 years and beyond. Blood. 2013 Jul 25;122(4):491-8. doi: 10.1182/blood-2013-02-453175. Epub 2013 May 14. Review. — View Citation

Döhner H, Weisdorf DJ, Bloomfield CD. Acute Myeloid Leukemia. N Engl J Med. 2015 Sep 17;373(12):1136-52. doi: 10.1056/NEJMra1406184. Review. — View Citation

Dolstra H, Roeven MWH, Spanholtz J, Hangalapura BN, Tordoir M, Maas F, Leenders M, Bohme F, Kok N, Trilsbeek C, Paardekooper J, van der Waart AB, Westerweel PE, Snijders TJF, Cornelissen J, Bos G, Pruijt HFM, de Graaf AO, van der Reijden BA, Jansen JH, va — View Citation

Li X, Dong Y, Li Y, Ren R, Wu W, Zhu H, Zhang Y, Hu J, Li J. Low-dose decitabine priming with intermediate-dose cytarabine followed by umbilical cord blood infusion as consolidation therapy for elderly patients with acute myeloid leukemia: a phase II sing — View Citation

Mehta RS, Shpall EJ, Rezvani K. Cord Blood as a Source of Natural Killer Cells. Front Med (Lausanne). 2016 Jan 5;2:93. doi: 10.3389/fmed.2015.00093. eCollection 2015. Review. — View Citation

Stringaris K, Sekine T, Khoder A, Alsuliman A, Razzaghi B, Sargeant R, Pavlu J, Brisley G, de Lavallade H, Sarvaria A, Marin D, Mielke S, Apperley JF, Shpall EJ, Barrett AJ, Rezvani K. Leukemia-induced phenotypic and functional defects in natural killer c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year Overall survival	the overall survival rate of enrolled patients at the end of 2 years	2-years
Secondary	2-year Disease-free survival	DFS is measured from the date when CR is achieved. And the end includes death or relapse.	2-years