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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004264 |
Receipt No. | R000005113 |
Scientific Title | A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT) |
Date of disclosure of the study information | 2010/11/01 |
Last modified on | 2018/10/01 |
Basic information | ||
Public title | A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT) | |
Acronym | A PK/Phase I study of i.v. MMF for GVHD prophylaxis | |
Scientific Title | A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT) | |
Scientific Title:Acronym | A PK/Phase I study of i.v. MMF for GVHD prophylaxis | |
Region |
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Condition | ||
Condition | Refractory hematologic disorders, including
1. Acute myelogenous leukemia 2. Acute lymphoblastic leukemia 3. Myelodysplastic syndrome 4. Chronic myelogenous leukemia 5. Malignant lymphoma 6. Aplastic anemia |
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Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | This PK/Phase I study is conducted to establish i.v. MMF dosing for GVHD prophyraxis as a substitute for p.o. MMF at the inability to oral intake after allo-SCT. |
Basic objectives2 | Pharmacokinetics |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 1. PK analysis of i.v. MMF, and comparison of PK parameters between i.v. and p.o. MMF
2. Grade of treatment-related toxicity by using i.v. MMF |
Key secondary outcomes | 1. Time to hematopoietic recovery
2. The cumulative incidence and severity of acute GVHD until day 100 3. Overall survival and progression-free survival at day 100 and 1-year after allo-SCT 4. Drug interaction studies with MMF |
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 | For GVHD prophylaxis, MMF is administered 4-6 h after allo-SCT at a dose of 1000 mg i.v. (diluted to a concentration of 6 mg/ml using 5% Dextrose, over 2 h) thrice daily (or twice daily in the case of cord blood transplantation) from day 0 to day 10 (for up to 14 days). Thereafter, patients are changed to p.o. MMF at the same dose and interval. After day 31, the dose tapers depending on individual risk factors for GVHD.
Blood samples (2 ml) for PK analysis are collected in EDTA tubes at 0, 0.5, 1, 2, 4, 8, and 12 h after the morning dose on days 2 and 9 during i.v. MMF administration and at 0, 1, 2, 4, 8, and 12 h on day 16 during p.o. MMF administration. Total mycophenolic acid (MPA) levels are quantified by reverse-phase HPLC. After quantification, non-compartmental analyses of total MPA concentration time data are conducted to estimate the AUC. |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_6 | ||
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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. Age between 15 and 69 years
2. ECOG performance status 0 or 1 3. Written informed consent for participation |
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Key exclusion criteria | 1. Contraindication of MMF administration
2. SpO2 of less than 93% without oxygen inhalation 3. Serum creatinin of greater than 2.0mg/dl 4. Liver function with serum total bilirubin of greater than 2.0mg/dl, or AST of greater than 4.0 x ULN 5. Left ventricular ejection fraction of less than 50% 6. Past history of cardiac event, or significant cardiac disease 7. Uncontrolled diabetus mellitus 8. Another active neoplastic disease 9. Uncontrolled active infections 10. Serologically positive for HIV antibody and/or HBs antigen 11. Pregnant, or during breast feeding 12. Uncontrolled psychiatric disease 13. Allergic history to drugs used in the conditioning regimens or GVHD prophylaxis regimens 14. Patients suggested as ineligible by their attending physician |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kobe University Graduate School of Medicine | ||||||
Division name | Medical Oncology/Hematology, Department of Medicine | ||||||
Zip code | |||||||
Address | 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo | ||||||
TEL | 078-382-5820 | ||||||
hminami@med.kobe-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kobe University Hospital | ||||||
Division name | Medical Oncology/Hematology | ||||||
Zip code | |||||||
Address | 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo | ||||||
TEL | 078-382-5820 | ||||||
Homepage URL | |||||||
atsuo@med.kobe-u.ac.jp |
Sponsor | |
Institute | Kobe University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | School of Pharmacy and Pharmaceutical Science, Mukogawa Women's University |
Name of secondary funder(s) |
IRB Contact (For public release) | |
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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 | 神戸大学医学部附属病院(兵庫県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | https://www.ncbi.nlm.nih.gov/pubmed/295117 |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Management information | |||||||
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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=R000005113 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |