Status:
UNKNOWN
Infusion of Donor Derived Cytokine Induced Killer (CIK) Cells in Hematological Patients Relapsed After Haploidentical Stem Cell Transplant
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Conditions:
Relapsed Hematologic Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The haematological neoplasia relapse is the cause of higher mortality after allogeneic stem cell transplantation (HSCT). When transplantation fails the most common therapeutic strategy is to increase ...
Detailed Description
Disease relapse is a major cause of mortality following allogeneic hematopoietic stem cell transplantation (HSCT) for hematologic malignancies. When allogeneic transplant fails the most common therape...
Eligibility Criteria
Inclusion
- Male or female patients 18 years or older
- Patients treated with haploidentical allogeneic transplantation for hematologic malignancies, excluding Chronic Myeloid Leukemia (CML), such as acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), multiple myeloma (MM), myelofibrosis (MF) and myelodysplastic syndrome (MDS)
- To be enrolled to the safety run-in cohort, patients must have:
- \- Evidence of relapsed disease after allogeneic transplantation, including molecular, cytogenetic or overt hematologic relapse
- To be enrolled to the phase II cohort, patients must have:
- Evidence of relapsed disease after allogeneic transplantation, including, molecular, cytogenetic or overt hematologic relapse, or
- Mixed chimerism after the day +90, defined as \<75% donor in unfractionated bone marrow and/or \<75% donor in unfractionated Peripheral blood (PB) and/or \<75% donor in fractionated CD3+ peripheral blood.
- Availability of a donor willing to donate peripheral blood mononuclear cells
- Withdrawn of immune suppression at least 3 weeks before the beginning of the cell therapy program
- Written informed consent prior to any study procedures being performed
- For female patients:
- being postmenopausal for at least 1 year before the screening visit,OR
- being surgically sterile, OR
- if they are of childbearing potential, must agree to practice highly effective method of contraception and one additional effective (barrier) method from the time of signing the informed consent until the end of study. Highly effective method of contraception includes: (i) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal; (ii) progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable (intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence) OR
- must agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject from the time of signing the informed consent until the end of study. \[Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.\]
- For male patients, even if surgically sterilized (i.e., status postvasectomy): a) with female partners of childbearing potential: must agree to practice barrier contraception (condom with or without spermicide) from the time of signing the informed consent until the end of study and his female partner must agree to practice method of contraception including one of the following: estrogen and progestogen containing hormonal contraception; inhibition of ovulation: oral, intravaginal, transdermal; progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable (intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion) from the time of signing the informed consent until the end of study.b) must agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject from the time of signing the informed consent until the end of study. \[Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.\] c) must agree to refrain from donating sperm
Exclusion
- The presence of any of the following will exclude a subject from study enrolment 1. Donors positive for HIV, (Hepatitis B virus) HBV, (Hepatitis C virus) HCV, Treponema or unfit to donate peripheral blood mononuclear cells 2. Patients with active grade 2 or more acute or moderate chronic GVHD at study entry or before CIK infusion 3. Patients with rapidly progressive disease or not controlled by palliative supportive treatments, including chemotherapy, and with life expectancy less than 8 weeks 4. Any serious medical or psychiatric illness, including drug or alcohol abuse, that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
- \-
Key Trial Info
Start Date :
January 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03821519
Start Date
January 13 2019
End Date
May 1 2023
Last Update
December 23 2021
Active Locations (1)
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1
A O Papa Giovanni XXIII
Bergamo, Italy, 24127