UMIN ID: UMIN000000865
Registered date:24/10/2007
Efficacy of intra-bone-marrow cord blood transplantation with reduced-intensity conditioning for adult hematological malignancies
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Acute leukemia, Chronic leukemia, Myelodysplastic syndrome, Malignant lymphoma, Multiple myeloma |
| Date of first enrollment | 2007/09/01 |
| Target sample size | 22 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Reduced-intensity conditioning followed byintra-bone-marrow cord blood transplantation |
Outcome(s)
| Primary Outcome | Probability of survival with engraftment at 60 days post-transplant |
|---|---|
| Secondary Outcome | Adverse events related to intra-bone-marrow injection, term to hematopoietic recovery, treatment-associated toxicity, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, transplant-related mortality, relapse rate, disease-free survival, overall survival, causes of death |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Any of the following. (1)Positive for HIV antibody or HBs antigen or HCV antibody (2)Patients treated with gemtuzumab ozogamicin within 6 months (3)Pregnant or during breast feeding (4)Patients with other malignant comorbidity (5)Uncontrolled psychiatric disease (6)Uncontrolled active infection (7)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen. (8)Impaired organ function (a)left ventricular ejection fraction smaller than 40% (b)FEV1.0 and TLC less than 30% (c)AST or ALT over 5xULN(NCI-CTCAE Grade 3) (d)serum creatinine over 3xULN(NCI-CTCAE Grade 3) (9)Re-transplant within 1 year from the previous transplantation (10)Cases that physicians judged as inappropriate. |
Related Information
| Primary Sponsor | Department of Hematology and Oncology, Nagoya University Graduate School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Hematology and Oncology, Nagoya University Graduate School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Makoto Murata |
| Address | 65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan Japan |
| Telephone | 052-744-2145 |
| mmurata@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University Graduate School of Medicine Department of Hematology and Oncology |
| scientific contact | |
| Name | Makoto Murata |
| Address | 65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan Japan |
| Telephone | 052-744-2145 |
| mmurata@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University Graduate School of Medicine Department of Hematology and Oncology |