UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000161 |
|---|---|
| Receipt number | R000000231 |
| Scientific Title | Phase I/II study of adoptive immunotherapy using predetermined minor histocompatibility antigen-specific cytotoxic T cells for patients with high-risk leukemia that relapsed following allogeneic hematopoietic stem cell transplantation. |
| Date of disclosure of the study information | 2005/09/12 |
| Last modified on | 2005/09/12 00:34:20 |
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Basic information
Public title
Phase I/II study of adoptive immunotherapy using predetermined minor histocompatibility antigen-specific cytotoxic T cells for patients with high-risk leukemia that relapsed following allogeneic hematopoietic stem cell transplantation.
Acronym
Cellular adoptive immunotherapy targeting predetermined minor histocompatibility antigens for the treatment of patients with relapsed leukemia following transplantation.
Scientific Title
Phase I/II study of adoptive immunotherapy using predetermined minor histocompatibility antigen-specific cytotoxic T cells for patients with high-risk leukemia that relapsed following allogeneic hematopoietic stem cell transplantation.
Scientific Title:Acronym
Cellular adoptive immunotherapy targeting predetermined minor histocompatibility antigens for the treatment of patients with relapsed leukemia following transplantation.
Region
| Japan |
Condition
Condition
1) RAEB, CMML 2) AML or ALL in induction failure or beyond first remission 3) Ph/p190-positive ALL at any stage 4) imatinib-resistant CML
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I/II study to evaluate the safety and efficacy of adoptive immunotherapy using cytotoxic T cells specific for predetermined minor histocompatibility antigens in treating patients with high-risk leukemia following allogeneic hematopoietic stem cell transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
1) Determine the toxicity including grade II or more acute GVHD from the initiation of T cell infusion to 2 weeks after the last infusion and extensive chronic GVHD. 2) Determine the non-hematological toxicity (grade 3 or 4) from the initiation of T cell infusion to 2 weeks after the last infusion.
Key secondary outcomes
1) Determine the CR rate from the initiation of T cell infusion to 2 weeks after last infusion. 2) Determine the persistence and kinetics of transfused T cells in vivo from the initiation of T cell infusion to 2 weeks after last infusion. 3) Determine the T cell number that can be infused safely.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Upon relapse, immunosuppressive drugs are withdrawn. If necessary, cytoreductive chemotherapy may be administered before adoptive immunotherapy. In the absence of unacceptable toxicity due to cessation of immunosuppressive drugs or chemotherapy, patients receive weekly CTL clone infusion 5 times. Initial dose is 3 million cells/m2. Cell numbers are escalated by 3.2 times each infusion. If anti-leukemic effect is observed, dose escalation is suspended.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed of one of the following type of leukemia: (a) RAEB, CMML, (b) AML or ALL in induction failure or beyond first remission, (c) Ph/p190-positive ALL at any stage, (d) imatinib-resistant CML 2) Aged 18 to 65 years 3) Sufficient organ function 4) ECOG PS 0-2 at time of enrollment 5) Patients receiving their first transplantation 6) Donor-patient pairs possessing appropriate disparity in predetermined minor histocompatibility antigens and restriction HLA alleles (i.e., BCL2A1/A24, HA-1/A*0201). 7) Written informed consent from the patients or their legal guardians (under 20 years old). 8) No other complications not suitable for transplantation. 9) Eligibility criteria at time of CTL infusion: (a) Patients with relapse at least 60 days after transplantation. (b) CTL clones must have been generated and have completed QC testing before treatment. (c) Relapsed leukemia as clearly defined by 1 or more of the following: morphologic relapse, cytogenetic relapse, molecular relapse. (d) Patients with >= grade III acute GVHD after transplantation. Patients with >= grade II acute GVHD or extensive chronic GVHD after cessation of immunosuppressive drugs other than maintenance dose of steroid. (e) No non-hematopoietic organ toxicity >= grade 3 one week prior to CTL infusion (NCI-CTC). (f) Neutrophil counts >= 200/ul at least 10 days after completion of cytoreductive chemotherapy.
Key exclusion criteria
1) CNS involvement or uncontrollable extramedullary disease. 2) Severe infections (including active tuberculosis) or double cancer 3) Patients with organ toxicity as follows: (a) T.Bil >= 1.5 mg/dl, (b) GOT, GPT >= 2.5 x N (upper normal limit of individual institutions), (c) serum creatine >= 1.5 x N, 24-h Ccr =< 60 ml/min, (d) PaO2 < 60 mmHg, (e) ejection fraction <50%, (f) abnormal ECG (ischemic change or arrhythmia requiring treatment) 4) Uncontrolable HT 5) One of the following: positive HBs antigen, seropositive to HCV, seropositive to HIV, seropositive to HTLV-1, seropositive to STS 6) Patients treated with major tranquilizer or antidepressant 7) Patients inappropriate for transplantation with reasons other than above.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Akatsuka, M.D.,Ph.D |
Organization
Aichi Cancer Center
Division name
Division of Immunology, Department of Cell Therapy and Hematology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, JAPAN
TEL
052-762-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Akatsuka, M.D.,Ph.D |
Organization
Aichi Cancer Center
Division name
Division of Immunology, Department of Cell Therapy and Hematology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, JAPAN
TEL
052-762-6111
Homepage URL
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2003 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 12 | Day |
Last modified on
| 2005 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000231
