Haploidentical Transplantation With Early Adoptive Transfer of CD56+CD3- NK Cells
NCT ID: NCT01220544
Last Updated: 2010-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2001-07-31
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HaploTransplant with NK cells
Haploidentical transplantation of mega-dose CD34+ hematopoetic stem cells with transfer of CD56+CD3-NK cells at day +2
Haploidentical transplantation with donor NK cells
Pat received a myeloablative conditioning regimen with 12 Gy total-body irradiation in six single doses from day -11 to day -9, thiotepa (5mg/kg/d) on days -8 and -7, fludarabine (40mg/m2/d) from day -6 to day -3, and OKT-3 (5mg/d) from day -5 to day +3. The stem cell graft was aimed to contain \> 8 x 10e6 CD34+ cells/kg and \< 5 x 10e4 CD3+ cells/kg. A minimum of 1 x 10e7 CD56+CD3- NK cells/kg will be transferred on days +2.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Haploidentical transplantation with donor NK cells
Pat received a myeloablative conditioning regimen with 12 Gy total-body irradiation in six single doses from day -11 to day -9, thiotepa (5mg/kg/d) on days -8 and -7, fludarabine (40mg/m2/d) from day -6 to day -3, and OKT-3 (5mg/d) from day -5 to day +3. The stem cell graft was aimed to contain \> 8 x 10e6 CD34+ cells/kg and \< 5 x 10e4 CD3+ cells/kg. A minimum of 1 x 10e7 CD56+CD3- NK cells/kg will be transferred on days +2.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. AML with aberration Del (5q) -5, del (7q) -7, t(9;22) or t(6;9), abn 3q, 9q, 11q, 20q, 21q, 17p;
2. AML with a complex caryotype;
3. secondary AML after previous chemo- or radiotherapy or MDS;
4. Ph-positive ALL
* Patients with AML or ALL after induction failure or in second CR
* Patients with CML in second chronic or accelerated phase
* Patients with malignant Lymphoma and the following high risk features:
1. relapse after autologous transplantation
2. primary chemotherapy refractory disease
* All patients must fulfill the following criteria:
1. lack of a suitable HLA-identical family, unrelated or cord blood donor
2. no active infection, no severe impairment of cardial, pulmonary, renal and hepatic function
3. blast count in the marrow \< 30%
4. informed consent
Exclusion Criteria
* blast count in the marrow \> 30%
* unable or unwilling to sign and/or understand informed consent
18 Years
54 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Leipzig
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Charite University Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lutz Uharel, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University Medicine
Dietger Niederwieser, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leipzig
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Charite Campus Benjamin FRanklin, Medical Clinic III, Department of Hematology/Oncology
Berlin, State of Berlin, Germany
Medical Clinic II, Department of Hematology/Oncology, University of Leipzig
Leipzig, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BELEHAPLO-1412001
Identifier Type: -
Identifier Source: org_study_id