Neoplasms

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Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

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All Drugs and Chemicals

Analgesics

Cytarabine

Mitoxantrone

Daunorubicin

Idarubicin

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Antibiotics, Antitubercular

Enzyme Inhibitors

Antimetabolites

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Immunologic Factors

High dose ARA-C will be applied after two 7+3 induction courses during the first and the second consolidation courses: ARA-C 1 g/m2 bid 1-3 days with idarubicin (8mg/m2 3-5 days)and mitoxantrone (10 mg/m2 3-5 days)

Standard dose ARA-C will be applied after two 7+3 induction courses the first and the second consolidation courses : ARA-C 100 g/m2 bid 1-7 days with idarubicin (8mg/m2 1-3 days)and mitoxantrone (10 mg/m2 1-3 days)

high dose ARA-C consolidation together with high cumulative dose of anthracyclines daunorubicin, idarubicin, mitoxantrone(720-660 mg/m2)

high dose ARA-C

standard dose ARA-C

Valeriy G Savchenko

The goal: to evaluate the role of high dose ara-c plus idarubicin and mitoxantrone consolidation followed by maintenance in the setting of high total cumulative anthracyclines dose(720-660 mg/m2).

In previous Russian AML multicenter studies it was shown that escalation of ARA-C dose (from 5,6 g to 72 g in 4 induction/consolidation courses) in parallel with anthracyclines dose reduction (from 630 mg/m2 to 285 mg/m2)did not improve survival, but decreased feasibility. In the ongoing trial we try to learn whether anthracyclines dose escalation (up to 720-660 mg m2) will or will not equivalise the standard (5,6 g in 4 induction/consolidation courses) and high (14,8 g) ARA-C doses.

3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia

Multicenter Randomised Clinical Trial in Acute Myeloid Leukemia Treatment Based on Three Anthracyclines, Comparing Two Types of Consolidation With Different ARA-C Doses Followed by One Year Maintenance

National Research Center for Hematology, Russia

MD PhD

Antibodies

Immunoglobulins

Ficlatuzumab 5-20 mg/kg; intravenous; Days 0, 14, 28, 42; Number of cycles: until progression or unacceptable toxicity develops.

Cytarabine 2 g/m2; intravenous; Days 2-7; Number of cycles: until progression or unacceptable toxicity develops.

5-20 mg/kg; intravenous; Days 0, 14, 28, and 42. Number of cycles: until progression or unacceptable toxicity develops.

Ficlatuzumab

2 g/m2; intravenous; Days 2-7; Number of cycles: until progression or unacceptable toxicity develops.

Charalambos Andreadis, MD

The purpose of this study is to see if ficlatuzumab when combined with cytarabine, a standard treatment for AML, is safe to give to patients and to determine the best dose to give. The study doctors want to see what effects, good and/or bad, the study drug has on subjects and their AML. The study will look at what side effects subjects may have and how subjects feel after receiving the study drug.

Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML

Phase Ib Study of Ficlatuzumab With High Dose Cytarabine (HiDAC) in Relapsed and Refractory AML

AVEO Pharmaceuticals, Inc.

Gateway for Cancer Research

C. Babis Andreadis

Associate Professor of Clinical Medicine

High-dose cytarabine 3.0 g/m2 q12hr 3-hour iv infusion on days 1, 3, 5 plus daunorubicin 45 mg/m2/day continuous iv infusion for 3 days (D1-3).

cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7) plus high-dose daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).

High dose Cytarabine 3.0 g/m2 q12hr 3-hour iv infusion on days 1, 3, 5 plus daunorubicin 45 mg/m2/day continuous iv infusion for 3 days (D1-3).

High dose Cytarabine

cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7)

Hign dose Daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).

Hign dose Daunorubicin

Je-Hwan Lee, MD

This trial is a single-center, non-blind, two-arm randomized prospective controlled trial to compare the effectiveness of two induction chemotherapy regimens (high-dose cytarabine plus daunorubicin \[HDAC\] vs. cytarabine plus high-dose daunorubicin \[AD\]) in acute myeloid leukemia (AML). The primary hypothesis of the study is that AD is superior to HDAC in terms of event-free survival (EFS, time from registration to induction failure, relapse, or death).

* Induction chemotherapy

  * Arm I \[HDAC\]: cytarabine 3.0 g/m2 q12hr 3-hour iv infusion on days 1, 3, 5 plus daunorubicin 45 mg/m2/day continuous iv infusion for 3 days (D1-3).
  * Arm II \[AD\]: cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7) plus daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).
* Interim bone marrow examination Interim bone marrow aspiration and biopsy will be done between 14 and 21 days after start of induction chemotherapy. If bone marrow has blasts \< 10%, no additional chemotherapy will be given until the recovery of blood counts (absolute neutrophil counts rise over 1,000/μL and platelet counts over 100,000/μL) or post-induction day 35, when bone marrow examination will be repeated to evaluate CR. After the marrow examination, re-induction course will be given. If interim bone marrow examination shows persistent leukemia (blasts ≥ 10%), re-induction course could be given. Patients who did not attain CR after the re-induction chemotherapy will be eliminated from the study.
* Re-induction chemotherapy

  * Cytarabine 200 mg/m2/day iv infusion for 5 days (D1-5) plus daunorubicin 45 mg/m2/day iv infusion for 2 days (D1-2) Post-remission consolidation chemotherapy
  * Adverse risk group: up to 3 courses of intermediate-dose cytarabine (1.0 g/m2/day iv for 5 days \[D1-5\]) plus etoposide (150 mg/m2/day iv for 3 days \[D1-3\])
  * Favorable/intermediate risk group: up to 3 courses of high-dose cytarabine (3.0 g/m2/day q12 hr iv for 3 days \[D1, 3, 5\])
  * Autologous or allogeneic hematopoietic cell transplantation (HCT) can be performed based on the risk of relapse.
  * The bone marrow examination will be done after the completion of consolidation chemotherapy or before HCT.

A Prospective Randomized Comparison of HDAC vs AD in the Induction Chemothrapy for AML.

A Prospective Randomized Comparison of High-dose Cytarabine an High-dose Daunorubicin in the Induction Chemothrapy for Acute Myeloid Leukemia

defined for all patients achieving CR; measured from the date of CR achievement until the date of relapse; patients not known to have relapsed are censored on the date they were last examined; patients who died without relapse are counted as a competing cause of failure

Defined for all patients; measured from the starting date of registration to the date of induction treatment failure, or relapse from CR, or death from any cause; patients not known to have any of these events are censored on the date they were examined

Defined for all patients; measured from the starting date of registration to the date of death from any cause-patients not known to have died at last follow-up are censored on the date they were last known to be alive

Asan Medical Center

Principal Investigator

Symptoms and General Pathology

Pathologic Complete Response

Disease Progression

Disease Attributes

Subject on this arm will be treated with HiDAC prospectively.

Subjects on this arm will be historical controls who have previously received treatment with HiDAC.

Subjects on this arm will prospectively receive consolidation therapy with cytarabine. Subjects will be treated with 1000 mg/m2 cytarabine intravenously every 12 hours on Days 1-3 of each consolidation cycle. Subjects will receive up to four consolidation cycles.

Subjects on this arm will have received consolidation therapy with cytarabine between 2/1/2017 and 2/1/2019. Subjects will have received 1000 mg/m2 cytarabine intravenously every 12 hours on days 1, 3, and 5 of each consolidation cycle and will have received up to 4 consolidation cycles.

Jack Hsu, MD

This phase 2, open label, non-randomized study will evaluate the safety of administering high dose cytarabine (HiDAC) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, and 5 of each cycle, in patients 61 years and older with de novo acute myeloid leukemia (AML).

Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission

Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) in Complete Remission

Determine the duration of neutropenia in older patients with de novo AML after consolidation chemotherapy with HiDAC 123, as compared to historical controls treated with HiDAC 135.

Determine the duration of thrombocytopenia in older patients with de novo AML after consolidation chemotherapy with HiDAC 123, as compared to historical controls treated with HiDAC 135.

Compare the incidence of documented infections (bloodstream infection, pneumonia, invasive fungal infection, Clostridium difficile infection, typhlitis, and febrile neutropenia) in patients receiving HiDAC 123 and HiDAC 135.

Compare the number of red blood cell and platelet transfusions per cycle in patients receiving HiDAC 123 and HiDAC 135.

Compare the incidence of readmission and the length of readmission stay in patients receiving HiDAC 123 and HiDAC 135.

Compare the differences in non-hematologic toxicities in patients receiving HiDAC 123 and HiDAC 135.

Compare the time to next treatment (next chemotherapy cycle, transplant, etc.) in patients receiving HiDAC 123 and HiDAC 135.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia	NCT01587430	Acute Myeloid L...	high dose ARA-C standard dose A...	15 Years - 60 Years	National Research Center for Hematology, Russia
3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia	NCT01587430	Acute Myeloid L...	high dose ARA-C standard dose A...	15 Years - 60 Years	National Research Center for Hematology, Russia
Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML	NCT02109627	Acute Myeloid L... Relapsed Acute ... Refractory Acut...	Ficlatuzumab Cytarabine	18 Years -	University of California, San Francisco
A Prospective Randomized Comparison of HDAC vs AD in the Induction Chemothrapy for AML.	NCT03507842	Acute Myeloid L...	High dose Cytar... Cytarabine Hign dose Dauno...	15 Years - 60 Years	Asan Medical Center
Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission	NCT04914676	Acute Myeloid L...	Cytarabine Cytarabine	61 Years - 99 Years	University of Florida
A Prospective Randomized Comparison of HDAC vs AD in the Induction Chemothrapy for AML.	NCT03507842	Acute Myeloid L...	High dose Cytar... Cytarabine Hign dose Dauno...	15 Years - 60 Years	Asan Medical Center

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