A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML)

NCT00808080 | Terminated Phase 1 Results DMC

• 1 other identifier: 070768
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this protocol is to investigate a novel form of immune therapy for patients with acute myelogenous leukemia (AML) who are in remission (CR) but who are at high risk for relapse.

Conditions

AML

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• 6 Dose Cohorts for Safety Monitoring. Each Cohort is Assessed for DLT for One Month After Autologous Cultured CTL Infusion Prior to Enrolling the Next Cohort.

  2.5 years estimated

Secondary Outcomes (1)

• If Phase I Has Successfully Shown the Target Dose to be Below the MTD Continue Enrolling Until 38 Patients Have Received the Target Dose. Patients Will be Monitored for Safety and Efficacy.

  2.5 years estimated

Study Arms (1)

Biologic

EXPERIMENTAL

AML\_CTL cells

Biological: AMLCTL

Interventions

AMLCTL BIOLOGICAL

Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)

Biologic

Eligibility Criteria

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

You may qualify if:

• Diagnosis of AML, not M3
• At least 10% of circulating leukocytes are AML blast cells
• Age 18 through 75
• Sex male or female
• Patient is considered a potential candidate for AHSCT

You may not qualify if:

• Participation in another immunotherapy trial within 30 days
• Presence of active malignancy other than AML
• History of autoimmune disease requiring systemic treatment
• ECOG performance status of 3 or 4
• Major organ system dysfunction
• Recent (30 days) or current use of steroids other than topical skin preparations
• History of allogeneic transplant
• Patients who, for any reason are not deemed candidates for AHSCT
• Eligibility for autologous CTL Infusion:
• Patient has CTL that are in sufficient number and are suitable for infusion
• Patient is stable, afebrile, engrafted, ECOG status 0-2, in CR and received AHSCT 45 - 60 days earlier.
• Temperature \> 38 C and/or known to be infected
• Absence of engraftment ANC \> 500 and Plt \> 20,000 unsupported
• Life expectancy less than 6 weeks
• Autoimmune disease requiring systemic treatment.

Sponsors & Collaborators

• Thomas A. Lane, MD: lead

Study Sites (1)

UCSD

La Jolla, California, 92093, United States

Location

Limitations and Caveats

Accrual trial was insufficient. No patient became eligible for CTL infusion. Cell culture information gleaned from a comparison of different culture methods will greatly facilitate future studies of autologous CTL-directed immunotherapy for AML.

Results Point of Contact

• Title: Dr. Thomas Lane, Stem Cell Lab Director
• Organization: UC San Diego Moores Cancer Center

jreiner@Ucsd.edu

858-822-5364

Study Officials

• Thomas Lane, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: January 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 9, 2019
• Results First Posted: February 22, 2016

Record last verified: 2019-04

Locations

US (1)