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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000162
Receipt No. R000000232
Scientific Title Phase I/II study of adoptive immunotherapy using cytotoxic T cells specific for minor histocompatibility antigen restricted to hematopoietic 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

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Basic information
Public title Phase I/II study of adoptive immunotherapy using cytotoxic T cells specific for minor histocompatibility antigen restricted to hematopoietic cells for patients with high-risk leukemia that relapsed following allogeneic hematopoietic stem cell transplantation
Acronym Cellular adoptive immunotherapy using CTL specific for hematopoietic-lineage minor histocompatibility antigen for the treatment of patients with relapsed leukemia following transplantation.
Scientific Title Phase I/II study of adoptive immunotherapy using cytotoxic T cells specific for minor histocompatibility antigen restricted to hematopoietic cells for patients with high-risk leukemia that relapsed following allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym Cellular adoptive immunotherapy using CTL specific for hematopoietic-lineage minor histocompatibility antigen 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 minor histocompatibility antigens restricted to hematopoietic cells 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) Written informed consent from the patients or their legal guardians (under 20 years old). 7) No other complications not suitable for transplantation. 8) 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
Email

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
Email yakatsuk@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center
Institute
Department

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
Email

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
2004 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2009 Year 03 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000232

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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