Clinical trial · Interventional
A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell (AHSC) Transplantation for Acute Myeloid Leukemia (AML)
A Clinical Trial of Cytotoxic T Cells Augmenting Autologous Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia
NCT00808080CI-TRIAL-00038029AMLCTLterminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMLCTL | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biologic
- description
- AML\_CTL cells
- interventionNames
- Biological: AMLCTL
Primary outcomes (1)
- 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 (1)
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.