Study Results
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Basic Information
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RECRUITING
PHASE1/PHASE2
23 participants
INTERVENTIONAL
2020-12-03
2025-09-01
Brief Summary
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Detailed Description
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This is a prospective phase I/IIa study. The first phase is a IL-2 dose-escalating safety study in twelve patients. The second phase of the study is designed as a Simon's optimal two-stage single-arm phase IIa study, comprising seventeen patients. Prior to NK cell infusion, all patients will receive cyclophosphamide and fludarabine (Cy/Flu) based lymphodepleting chemotherapy. On day 0, all patients will receive a fixed dose of 1.0-3.0 x 10\^9 allogeneic umbilical cord blood-derived NK cells (UCB-NK cells). These cells are generated ex vivo from CD34+ hematopoietic progenitor cells obtained from an allogeneic UCB unit.
In phase I of the study patients will receive UCB-NK cells without subcutaneous (SC) IL-2, with lower dose SC IL-2 or with higher dose SC IL-2 (n=3 per treatment group, n=6 in the highest tolerable dose). After establishing the safety of UCB-NK cells combined with SC IL-2, we will continue with phase IIa of the study, with ten patients in the first stage (including the six patients from phase I with comparable IL-2 dose) and if clinical efficacy is achieved an additional seven patients in the second stage.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
The primary objective of phase IIa of the study is to evaluate the effect of UCB-NK cell adoptive immunotherapy in combination with SC IL-2 following a non-myeloablative immunosuppressive conditioning regime on disease activity in patients with AML. Therefore 17 patients will be evaluated using a Simon's optimal two-stage single-arm study design, with 10 patients in the first stage and an additional 7 patients in the second stage. These patients will receive NK cells with the highest tolerable dose IL-2, established after phase I.
TREATMENT
NONE
Study Groups
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NK cells without IL-2
On day 0, patients will receive a fixed dose of 1.0-3.0 x 10\^9 allogeneic UCB-NK cells. Prior to NK cell infusion, patients will receive cyclophosphamide and fludarabine (Cy/Flu) based lymphodepleting chemotherapy. NK cells administration will not be followed by sc IL-2. N=3.
UCB-NK cells
Natural killer cells generated from CD34+ hematopoietic progenitor cells derived from an allogeneic umbilical cord blood
NK cells with low dose IL-2
On day 0, patients will receive a fixed dose of 1.0-3.0 x 10\^9 allogeneic UCB-NK cells. Prior to NK cell infusion, patients will receive cyclophosphamide and fludarabine (Cy/Flu) based lymphodepleting chemotherapy. IL-2 will be administered in a fixed dose of 3.0 x 10\^6 units starting 4 hours after NK cell infusion and given every other day for 6 doses in total. N=3
UCB-NK cells
Natural killer cells generated from CD34+ hematopoietic progenitor cells derived from an allogeneic umbilical cord blood
IL-2
In vivo cytokine support
NK cells with higher dose IL-2
On day 0, patients will receive a fixed dose of 1.0-3.0 x 10\^9 allogeneic UCB-NK cells. Prior to NK cell infusion, patients will receive cyclophosphamide and fludarabine (Cy/Flu) based lymphodepleting chemotherapy. IL-2 will be administered in a fixed dose of 6.0 x 10\^6 units starting 4 hours after NK cell infusion and given every other day for 6 doses in total. N=6
UCB-NK cells
Natural killer cells generated from CD34+ hematopoietic progenitor cells derived from an allogeneic umbilical cord blood
IL-2
In vivo cytokine support
Interventions
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UCB-NK cells
Natural killer cells generated from CD34+ hematopoietic progenitor cells derived from an allogeneic umbilical cord blood
IL-2
In vivo cytokine support
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients may belong to any of the following categories:
* Relapsed/refractory disease after treatment with intensive chemotherapy, hypomethylating agents, targeted agents, autologous or allo-SCT (at least 6 months ago) and DLI
* Newly diagnosed, untreated patients ineligible for allo-SCT
* Age ≥ 18 years
* WHO performance 0-2
* Life expectancy of \> 4 months
* Written informed consent
* Hydrea is allowed as pre-treatment to control blast count until day -3
* Other disease controlling medication is allowed until day -7
Exclusion Criteria
* Patients on immunosuppressive drugs or active GvHD
* Patients with active infections (viral, bacterial or fungal); acute anti-infectious therapy must have been completed within 14 days prior to study treatment
* Severe cardiovascular disease (CTCAE III-IV)
* Severe pulmonary dysfunction (CTCAE III-IV)
* Severe renal dysfunction (CTCAE III-IV)
* Severe hepatic dysfunction (CTCAE III-IV)
* Severe neurological or psychiatric dysfunction (CTCAE III-IV)
* Patients on concurrent chemotherapy or interferon-alpha treatment
* Pregnancy or breastfeeding
18 Years
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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N.P.M. Schaap
Role: PRINCIPAL_INVESTIGATOR
Department of Hematology
Locations
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Radboud University Medical Center
Nijmegen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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H. Dolstra, Ass. Prof.
Role: primary
References
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Dolstra H, Roeven MWH, Spanholtz J, Hangalapura BN, Tordoir M, Maas F, Leenders M, Bohme F, Kok N, Trilsbeek C, Paardekooper J, van der Waart AB, Westerweel PE, Snijders TJF, Cornelissen J, Bos G, Pruijt HFM, de Graaf AO, van der Reijden BA, Jansen JH, van der Meer A, Huls G, Cany J, Preijers F, Blijlevens NMA, Schaap NM. Successful Transfer of Umbilical Cord Blood CD34+ Hematopoietic Stem and Progenitor-derived NK Cells in Older Acute Myeloid Leukemia Patients. Clin Cancer Res. 2017 Aug 1;23(15):4107-4118. doi: 10.1158/1078-0432.CCR-16-2981. Epub 2017 Mar 9.
Other Identifiers
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2019-001929-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HEMAML42
Identifier Type: -
Identifier Source: org_study_id
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