Trial record 1 of 1 for:
NCT00914628
Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia (TK008)
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| ClinicalTrials.gov Identifier: NCT00914628 |
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Recruitment Status :
Terminated
(EMA withdrew the marketing Authorisation at the request of AGC Biologics S.p.A (formerly MolMed S.p.A), which decided to permanently discontinue the marketing of the product for commercial reasons)
First Posted : June 5, 2009
Results First Posted : June 22, 2021
Last Update Posted : June 22, 2021
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Sponsor:
AGC Biologics S.p.A.
Information provided by (Responsible Party):
AGC Biologics S.p.A.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Acute Leukemia (Category) |
| Interventions |
Genetic: HSV-Tk Other: T-cell depleted or T-cell replete strategies |
| Enrollment | 92 |
Participant Flow
| Recruitment Details |
Study period: Date of First patient enrolled: 12.04.2010; Date of Last patient completed: 30.11.2019; Date of End of study: 30.11.2019. |
| Pre-assignment Details | Planned sample size n.170; Randomized patients n. 92. Discontinued n. 70; Early termination by the Sponsor n. 22; |
| Arm/Group Title | A-Experimental Arm | B - Control Arm |
|---|---|---|
 Arm/Group Description |
Patients received an infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) followed by the infusion of HSV-TK genetically modified CD3+ cells. In absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis. HSV-TK engineering donor Lymphocytes |
The physician could choose between the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) or unmanipulated haploidentical transplantation (bone marrow or peripheral blood) followed by high-dose cyclophosphamide. |
| Period Title: Overall Study | ||
| Started | 64 [1] | 28 [1] |
| Completed | 0 [2] | 0 [2] |
| Not Completed | 64 | 28 |
| Reason Not Completed | ||
| Death | 35 | 17 |
| Medical decision | 4 | 0 |
| Protocol Violation | 1 | 0 |
| Lack of Efficacy | 1 | 0 |
| non-randomized | 1 | 0 |
| Relapse | 1 | 2 |
| Study terminated by Sponsor | 14 | 8 |
| Patients who did not receive a single dose | 7 | 1 |
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[1]
Referred to all randomized patient
[2]
Early termination of the Study
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Baseline Characteristics
| Arm/Group Title | A - Experimental Arm | B- Comparator Arm | Total | |
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Arm/Group Description |
patients received the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg), followed by the infusion of HSV-TK genetically modified CD3+ cells In absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis. | the physician chose whether the patient received the infusion of CD34+ cells plus a dose of T cells (approximately 1 x 104/Kg) or an unmanipulated haploidentical bone marrow or peripheral blood transplant followed by high-dose cyclophosphamide. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 64 | 28 | 92 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 64 participants | 28 participants | 92 participants | |
| 45.89 (15.29) | 51.43 (12.41) | 47.58 (14.63) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 64 participants | 28 participants | 92 participants | |
| Female |
23 35.9%
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9 32.1%
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32 34.8%
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| Male |
41 64.1%
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19 67.9%
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60 65.2%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 64 participants | 28 participants | 92 participants | |
| Asian |
1 1.6%
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0 0.0%
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1 1.1%
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| Black |
3 4.7%
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1 3.6%
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4 4.3%
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| Caucasian |
55 85.9%
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24 85.7%
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79 85.9%
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| Other |
5 7.8%
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3 10.7%
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8 8.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Anna Stornaiuolo |
| Organization: | AGC Biologics S.p.A |
| Phone: | 00390221277440 |
| EMail: | astornaiuolo@agcbio.com |
| Responsible Party: | AGC Biologics S.p.A. |
| ClinicalTrials.gov Identifier: | NCT00914628 |
| Other Study ID Numbers: |
TK008 2009-012973-37 ( Registry Identifier: EUdraCT number ) |
| First Submitted: | June 3, 2009 |
| First Posted: | June 5, 2009 |
| Results First Submitted: | February 12, 2021 |
| Results First Posted: | June 22, 2021 |
| Last Update Posted: | June 22, 2021 |