CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Autologous CIK cell infusionbiological
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00815321
NCT00815321Phase 2Completed

Autologous Cytokine Induced Killer Cells as Adjuvant Adoptive Immunotherapy in Patients With Chronic Myeloid Leukemia on Standard Drug Therapy

Singapore General Hospital·interventional·Posted Dec 30, 2008·Updated Feb 10, 2017

In Brief

A Phase 2 clinical trial evaluating Autologous CIK cell infusion for Chronic Myeloid Leukemia. Completed, enrolled 11 participants across 1 site.

Detailed Summary

This is an extension of our ongoing clinical trial using ex vivo expanded autologous Cytokine-induced killer (CIK) cells as an adoptive cellular immunotherapy for haematological malignancies. The pre-existing clinical trial targets patient with acute myeloid leukemia or MDS, and relapsed disease post allogeneic transplant. Chronic myeloid leukemia (CML) is a disease with good response to kinase inhibitors. There are however patients in transformed phase of the disease who do not respond to these treatment. A small proportion of patients with response to Imatinib may develop mutations resulting in drug resistance. In addition, the vast majority of patients with a good response to the kinase inhibitors still have persistent CML cells detectable at a molecular level. It is known that the CML progenitors are not sensitive to the kinase inhibitors. On the other hand, immune mediated mechanism is known to be able to eradicate CML as shown by efficacy of donor lymphocyte infusion in the allogeneic transplant setting. Early clinical trials have shown clearance of bcr-abl using peptide vaccination. There is also convincing mouse data showing eradication of CML at molecular level by autologous CIK cells, but no clinical trial has been done using CIK cells for CML. We therefore plan to expand our current CIK trial to include CML as a disease, for CML patients with various degree of response to the kinase inhibitors which have already offered its maximal effect. We aim to study whether autologous CIK cells may further improve disease response, either in the eradiation of minimal residual disease, or in conjunction with chemotherapy for control of high tumour load disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSingapore
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 30, 2008
Enrollment StartDec 1, 2008
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.5 years ago

Interventions

Autologous CIK cell infusionbiological

4 CIK cells will be infused into patients at regular 3-weekly intervals for 4 infusions. The target cell dose per infusion is 1x10e10 CD3 cells. For patients with uncontrolled accelerated or blastic transformation undergoing chemotherapy, this will be given at the nadir of lymphopenia following chemotherapy. For other patients this will be given without interruption of the ongoing treatment with Imatinib or other kinase inhibitor.