NK Cell Infusion for Patients With Acute Myeloid Leukemia

NCT04221971 | Unknown Phase 1

• 1 other identifier: 2019PHD005-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Natural killer (NK) cells exert antitumor effects via their cytotoxic and cytokine-secreting capacity without present of clinical symptoms. In recent years, with the continuous advancement of in vitro expansion methods, the application of good quality management technology, NK cells could be clinical grade expanded without the need for pre-purification, feeder-free, and serum-free culture. In this clinical trial the investigators want to demonstrate the safety and efficacy chemotherapy combined with donor-derived in vitro activated NK cells infusion for high risk AML patients.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Closely monitor the patient's temperature, rash, BP, and other adverse reactions during the 48 hours after the infusion, and pay attention to acute and chronic GVHD; follow up once every 1-2 weeks within 6 months after the infusion, and review the blood count and biochemistry. Increase or decrease the relevant inspections and inspection frequencies as appropriate according to the condition;

  Two months after NK treatment

Secondary Outcomes (4)

• Number of participants acheived CR post NK treatment

  One month after NK treatment

• Monitor the metabolism, migration and reconstruction of NK cells in vivo post NK treatment

  One month after NK treatment

• Assess the cell count recovery time of peripheral blood in chemotherapy combined with NK infusion

  Two months after NK treatment

• Number of participants relapsed post NK treatment

  Every months after NK treatment within 1 year

Study Arms (1)

AML patients with NK cells infusion

EXPERIMENTAL

The relapsed/refractory AML patient received Flu+CTX (Flu 25mg/m2 (-6d to -2d)，CTX 1.0g/m2 (-6d to -5d) and haploidentical NK cells infusion postchemotherapy for at least 48 hours. NK cell dose was over 1+E07/ kg with 3 consecutive infusions. NK cells infusion interval was 1 day.

Drug: chemotherapy combined with NK cells infusion

Interventions

chemotherapy combined with NK cells infusion DRUG

chemotherapy combined with NK cells infusion

Also known as: cyclophosphamide (Cy, 1000 mg/m2/day, day -6 to -5), and fludarabine (Flu, 25 mg/m2/day, day -6 to -2)

AML patients with NK cells infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AML patients receiving standard NCCN induction and consolidation chemotherapy;
• Age\> = 18 years old;
• Relapsed and refractory AML: continued non-remission after induction and consolidation chemotherapy with NCCN standard protocol, or relapse after remission, or continued MRD positive;
• MDS-RAEB, MDS-AML, MPD-AML;
• ECOG≤3;
• No serious organ dysfunction within 2 weeks before treatment:
• Heart: no arrhythmia and LVEF≥50% and no pericardial effusion;
• Liver: liver function \<2 times the upper limit of ALT and \<1.5 times the upper limit of total bilirubin, no active hepatitis;
• Kidney: serum creatinine \<1.5 mg / dl; or if serum creatinine exceeds the upper limit, serum creatinine clearance should be CrCl\> 50 ml / min;
• indoor fingertip blood oxygen saturation ≧ 92%;
• Expected survival time ≥ 3 months;
• The interval between re-induction therapy and NK cell therapy is at least 2 weeks, and the toxic and side effects of all induction remission treatments have disappeared; if the patient is receiving non-invasive chemotherapy, such as hydroxyurea, low-dose cytarabine, before receiving this program Should be discontinued before;
• All patients and donors are willing to join this clinical trial and sign informed consent.

You may not qualify if:

• Combined with a history of other malignant tumors \<5 years (except cured skin basal cell carcinoma, cured cervical carcinoma in situ and gastrointestinal tumors confirmed to be cured by endoscopic mucosal resection);
• Have received bone marrow or organ transplant;
• Those who are allergic to the biological agents used in this treatment;
• active infection;
• Those who received other cell treatments such as DLI, CMV-CTL, EBV-CTL;
• HBV carriers;
• Patients with extramedullary recurrence;
• Chest radiographic examination to determine patients with pulmonary inflammation;
• Researchers do not consider it appropriate to participate in this trial.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• The University of Science and Technology of China: collaborator

Study Sites (1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cyclophosphamide; fludarabine; Influenza Vaccines

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Xiao-Jun Huang, M.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang-Yu Zhao, M.D.

CONTACT

8610-88325949; zhao_xy@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: January 9, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)