A Study of DSP-2033 (Alvocidib) in Patients With Acute Myeloid Leukemia
NCT ID: NCT03563560
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2018-05-15
2020-03-31
Brief Summary
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Detailed Description
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1. To evaluate the safety of DSP-2033 (Alvocidib) in combination with cytarabine/mitoxantrone (ACM regimen) in Japanese patients with relapsed or refractory AML and to confirm its tolerability.
2. To evaluate the safety of DSP-2033 （Alvocidib) in combination with cytarabine/daunorubicin (A+7+3 regimen) in Japanese newly diagnosed AML patients and to confirm its tolerability.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ACM regimen
ACM regimen is for Japanese patients with relapsed or refractory AML.
Alvocidib
ACM regimen:30 mg/60 mg, 30-minute intravenous (IV) infusion, followed 4-hour IV infusion from Day 1 to Day 3 A+7+3 regimen: recommended dose (RD), 30-minute IV infusion, followed 4-hour IV infusion from Day 1 to Day 3
Cytarabine
300 or 667 mg/m2/day, 72-hour continuous IV infusion starting on Day 6 (ACM regimen)
Mitoxantrone
14 or 40 mg/m2/day, IV infusion over 1 hour to 2 hours at 12 hours after the end of DSP-AraC administration (acceptable range + 3 hours)
A+7+3 regimen
A+7+3 regimen is for Japanese newly diagnosed AML patients.
Alvocidib
ACM regimen:30 mg/60 mg, 30-minute intravenous (IV) infusion, followed 4-hour IV infusion from Day 1 to Day 3 A+7+3 regimen: recommended dose (RD), 30-minute IV infusion, followed 4-hour IV infusion from Day 1 to Day 3
Cytarabine
100 mg/m2/day, continuous IV infusion for 7 days from Day 5 to Day 11 (A+7+3 regimen)
Daunorubicine
60 mg/m2/day, 30-minute IV infusion for 3 days from Day 5 to Day 7
Interventions
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Alvocidib
ACM regimen:30 mg/60 mg, 30-minute intravenous (IV) infusion, followed 4-hour IV infusion from Day 1 to Day 3 A+7+3 regimen: recommended dose (RD), 30-minute IV infusion, followed 4-hour IV infusion from Day 1 to Day 3
Cytarabine
300 or 667 mg/m2/day, 72-hour continuous IV infusion starting on Day 6 (ACM regimen)
Mitoxantrone
14 or 40 mg/m2/day, IV infusion over 1 hour to 2 hours at 12 hours after the end of DSP-AraC administration (acceptable range + 3 hours)
Cytarabine
100 mg/m2/day, continuous IV infusion for 7 days from Day 5 to Day 11 (A+7+3 regimen)
Daunorubicine
60 mg/m2/day, 30-minute IV infusion for 3 days from Day 5 to Day 7
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Japanese patients diagnosed with AML by the 4th edition of WHO criteria.
2. Patients aged between 20 and 64 at acquisition of informed consent.
3. Have received an adequate explanation of the objectives/contents of the clinical study, anticipated therapeutic effects/pharmacology, and risks to his/her understanding, and voluntarily provide written informed consent to participation in the clinical study.
4. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2 at entry.
5. Have a left ventricular ejection fraction (LVEF) ≥ 50% determined by echocardiography or multigated acquisition (MUGA) scan within 14 days prior to entry.
6. Have an arterial oxygen saturation (SpO2) ≥ 90% within 14 days prior to entry.
7. The laboratory test within 14 days prior to entry (for multiple tests, the most recent before the entry) meet the following criteria for major organ function.
1. Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) of the institutional reference standard
2. AST and ALT ≤ 2 x ULN of the institutional reference standard
3. Total bilirubin ≤ 2.0 mg/dL
8. Female patients of childbearing potential must have negative pregnancy test results at entry.
9. Female patients or patients with partners of childbearing potential must agree to use an appropriate method of contraception for a period between acquisition of informed consent and 6 months (180 days) after the final dose so that patients or female partners would not become pregnant.
10. AML patients who could not attain remission after 1 or 2 cycles of potent chemotherapy with anthracycline, cytarabine, and etoposide, or potent chemotherapy with anthracycline and cytarabine. Or patients with 1st or 2nd recurrent AML after complete remission following initial therapy.
11. Treatment naive AML patients.
Exclusion Criteria
1. Diagnosed with acute promyelocytic leukemia (APL) (FAB classification: M3).
2. Received a transplantation such as hematopoietic stem cell transplant.
3. Have active central nervous system (CNS) leukemia.
4. Complicated by ≥ Grade 3 infection as specified in Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03).
5. HIV antibody, HBs antigen, or HCV antibody tested positive within 90 days prior to entry.
6. Have New York Heart Association (NYHA) cardiac function classification III or IV heart disease or a history, ≥ Grade 3 arrhythmia, angina pectoris or abnormal electrocardiogram (ECG) findings as specified in CTCAE v4.03 or a history of these above.
7. Have a disease that may interfere with the study treatment, such as interstitial pneumonia, pulmonary fibrosis, or active tuberculosis.
8. Complicated by uncontrolled disseminated intravascular coagulation.
9. Have other active malignancies (synchronous multiple malignancies and metachronous multiple malignancies with a disease-free interval not more than 5 years. However, carcinoma in situ that is determined to be cured by local treatment or lesions equivalent to mucosal carcinoma are not included in active multiple malignancies.)
10. Have an uncontrolled complication.
11. Complicated by mental deficits or have a history of mental deficits. However, patients who are able to comply with the study protocol can be included at the discretion of a physician.
12. Complicated by varicella.
13. Received any previous treatment with DSP-2033 or other CDK inhibitors.
14. Received any investigational product or post-marketing clinical study drug within 3 months (90 days) prior to entry.
15. Pregnant or lactating women\*)
\*) If a lactating woman agrees to discontinue breast feeding between acquisition of informed consent and 6 months (180 days) after the final dose, she could be included in the study.
16. Patients who are determined to be inappropriate for participation in this study by the investigator or subinvestigator.
17. Have the cumulative total exposure of anthracycline, daunorubicin-equivalent dose, exceeds 360 mg/m2 (body surface area) at entry.
18. Received other leukemia treatment within 21 days prior to entry.
19. Have a history of radiation therapy on the mediastinum.
20. Have sustained ≥ Grade 2 adverse drug reaction (except alopecia) as specified in CTCAE v4.03, which developed by the previous treatment.
21. Have a history of hypersensitivity against any one of cytarabine, mitoxantrone, or contained excipients.
22. Have the cumulative total exposure of anthracycline, daunorubicin-equivalent dose, exceeds 100 mg/m2 (body surface area) at entry.
23. Have a history of hypersensitivity against any one of cytarabine, daunorubicin, or contained excipients.
20 Years
64 Years
ALL
No
Sponsors
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Sumitomo Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fukui University Hospital
Yoshida-gun, Fukui, Japan
Chugoku Central Hospital
Fukuyama, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Osaka City Hospital Organization
Miyakojima-ku, Osaka, Japan
Kindai University Hospital
Sayama, Osaka, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan
Kyushu University Hospital
Fukuoka, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Countries
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References
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Ikezoe T, Ando K, Onozawa M, Yamane T, Hosono N, Morita Y, Kiguchi T, Iwasaki H, Miyamoto T, Matsubara K, Sugimoto S, Miyazaki Y, Kizaki M, Akashi K. Phase I study of alvocidib plus cytarabine/mitoxantrone or cytarabine/daunorubicin for acute myeloid leukemia in Japan. Cancer Sci. 2022 Dec;113(12):4258-4266. doi: 10.1111/cas.15458. Epub 2022 Oct 10.
Other Identifiers
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DC850101
Identifier Type: -
Identifier Source: org_study_id
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