Clinical trial NCT00808080: A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML)
Official title: A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: AML
Keywords: AML
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2008-12-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2.5 years estimated
Secondary outcomes:
measure: 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.
timeFrame: 2.5 years estimated
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
affiliation: UCSD
name: Thomas Lane, MD
role: PRINCIPAL_INVESTIGATOR
References: