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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | C000000253 |
Receipt No. | R000000319 |
Scientific Title | A phase I/II trial of HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning |
Date of disclosure of the study information | 2005/10/01 |
Last modified on | 2012/03/30 |
Basic information | ||
Public title | A phase I/II trial of HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning | |
Acronym | A phase I/II trial of HLA haploidentical minitransplantation | |
Scientific Title | A phase I/II trial of HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning | |
Scientific Title:Acronym | A phase I/II trial of HLA haploidentical minitransplantation | |
Region |
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Condition | ||
Condition | Chronic myeloid leukemia, Acute myeloid leukemia, Acute lymphoid leukemia, Myelodysplastic syndrome, Malignant lymphoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the safety and efficacy of HLA haploidentical peripheral blood stem cell transplantation following redeced-intensity conditioning for the patients with refractory hematological malignancies. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | Neutrophil engraftment within 35 days after transplantation (Phase I)
Overall survival at day 100 after transplantion (Phase II) |
Key secondary outcomes | Incidence and severity of acute GVHD
Incidence and severity of chonic GVHD Overall survival at 1 year after transplantation Diase free survival at 1 year after transplantation Treatment related mortality at 1 year after transplantation Incidence and severity of infectious disease after transplantation Immune reconstitution after transplantation |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 1 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) CML(2nd or later CP, AP, BC or relapse in non-CP state after allogeneic stem cell transplantation), AML(2nd or later CR, primary refractory or non-CR), ALL(2nd or later CR, primary refractory, non-CR or 1st CR in patients with Ph+ALL who could not achieve molecular remission), MDS/CMML(Int-II or high of the International Prognostic Scoring System, or relapse), Maglignant lymphoma (chemorefractory aggressive lymphoma)
2) Patients aged between 35 and 55 years. Patients aged between 18 and 35 years who are not eligible for myeloablative conditioning. 3) Written informed consent. 4) Unavailability of HLA-matched or -one antigen mismatched-related donor. Unavailability of HLA-matched or one allele mismatched-unrelated donor or needs urgent transplantation. 5) Availability of HLA-haploidentical family donor. 6) Performance status 0 or 1 7) Sufficient organ function |
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Key exclusion criteria | 1) Allergy for the agents used in conditioning or GVHD prophylaxis
2) Positivity for HBs antigen and/or HIV antibody 3) Active lesions in CNS 4) Active infections 5) Patients who are considered as inappropriate with other reasons |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hyogo College of Medicine | ||||||
Division name | Division of Hematology, Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 1-1, Mukogawa-cho, Nishinomiya, Hyogo | ||||||
TEL | 0798-45-6886 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Hyogo College of Medicine | ||||||
Division name | Division of Hematology, Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 1-1, Mukogawa-cho, Nishinomiya, Hyogo | ||||||
TEL | 0798-45-6886 | ||||||
Homepage URL | |||||||
haplo@hyo-med.ac.jp |
Sponsor | |
Institute | Health and Labour Sciences Research Grants, Research on Human Genome, Tissue Engineering, Ministry of Health, Labour and Welfare |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000319 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |