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

AML Clinical Trial

— AMLCTL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00808080
• Other study ID #: 070768
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: April 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary Aim: To conduct a Phase 1/2 clinical trial of autologous CTL-mediated immunotherapy in a homogeneous group of patients with AML who have recently received an autologous hematopoietic stem cell transplant. Specifically:

Phase 1: To determine the MTD of autologous AML-reactive cultured CTL in patients with AML who have recently received an AHSCT.

Phase 2: To determine 1 year progression-free survival of the study group vs institutional historical control group composed of a sequential series of recent patients who have received an AHSCT for AML.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria (Initial Eligibility Screen):

• 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

Exclusion criteria (Initial Eligibility Screen):

• 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:

Inclusion Criteria:

• 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.

Exclusion or delay criteria:

• 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.

• ECOG performance status of 3 or 4

• Major organ system dysfunction

Related Conditions & MeSH terms

• AML
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• AMLCTL
Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)

Locations

Country	Name	City	State
United States	UCSD	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Thomas A. Lane, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion. No CTL infusions were administered to any subject, consequently NO outcome measure results are available.	2.5 years estimated