Eltrombopag Olamine in Improving Platelet Recovery in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

NCT02071901 | Unknown Phase 2 Results DMC FDA Drug

• 2 other identifiers: CASE4913NCI-2014-00252
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well eltrombopag olamine works in improving the recovery of platelet counts in older patients with Acute Myeloid Leukemia (AML) undergoing induction (the first treatment given for a disease) chemotherapy. Platelet counts recover more slowly in older patients, leading to risk of complications and the delay of post-remission therapy. Eltrombopag olamine may cause the body to make platelets after chemotherapy.

Conditions

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Median Platelet Count >= 50,000/uL

  Number of participants with a median platelet count \>= 50,000/uL

  Day 24 of Treatment

Secondary Outcomes (13)

• Median Time Needed to Reach Platelet Count >= 50,000 /µL in Days

  up to 12 weeks

• Median Days of Platelet Transfusions

  Up to 12 weeks

• Rates of Clinically Significant Bleeding Events

  Up to 12 weeks

• Median Time to Absolute Neutrophil Recovery, Defined as > 500/uL

  Up to 12 weeks

• Median Rise in Hemoglobin Level in Patients With Pretreatment Hemoglobin of < 8 g/dL

  Up to 12 weeks

Study Arms (1)

Supportive care (eltrombopag olamine)

EXPERIMENTAL

Patients receive eltrombopag olamine by mouth (PO) daily (QD) until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.

Drug: eltrombopag olamine

Interventions

eltrombopag olamine DRUG

Given PO

Also known as: Promacta, SB 497115, SB-497115, SB497115

Supportive care (eltrombopag olamine)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All categories of AML will be included except for acute promyelocytic leukemia (APL), acute megakaryocytic leukemia, and acute leukemias of ambiguous lineage undergoing 7 + 3 remission IC with cytarabine and an anthracycline (daunorubicin or idarubicin). All cases have to be histopathologically confirmed by a diagnostic bone marrow biopsy. Use of granulocyte colony-stimulating factor (G-CSF) for any indication must have been discontinued at least 7 days prior to entry into the study.
• Patients with secondary AML arising out of Myelodysplastic syndrome (MDS) (all subtypes under WHO \[World Health Organization\] classification), chronic myelomonocytic leukemia (CMML); therapy-related AML and those with a prior autologous hematopoietic cell transplantation are eligible.
• No morphological evidence of disease on day 14 bone marrow examination following IC
• Must be able to give voluntary informed written consent to participate in the study; informed consent will be obtained prior to initiation of remission IC and before any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
• Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment. All men and women of childbearing potential must use acceptable methods of birth control throughout the study as described below:
• Females of childbearing potential: Recommendation is for 2 effective contraceptive methods during the study. Adequate forms of contraception are double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation.
• Male patients with female partners who are of childbearing potential: Recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study or to abstain.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent
• Any active malignancy (unrelated, non-hematological malignancy) diagnosed within the past 12 months of starting the study drug (other than curatively treated carcinoma-in-situ of the cervix or non-melanoma skin cancer).
• Secondary AML arising out of myeloproliferative neoplasms \[as per the revised 2008 WHO classification of myeloid neoplasms and acute leukemias\] and MDS/myeloproliferative disease (MPD) neoplasms other than CMML \[as per the revised 2008 WHO classification of myeloid neoplasms and acute leukemias\]. Refractory Anemia with Ringed Sideroblasts with thrombocytosis (RARS-T) classified as MDS/MPN neoplasm, unclassifiable will be excluded. AML patients with presenting features suspicious of underlying unrecognized MPD such as marked splenomegaly (\> 20 cm) and thrombocytosis (\>400,000 per microliter) will be excluded. Patients with relapsed or refractory AML will be excluded.
• Radiation therapy, cytotoxic chemotherapy, and combined modality (both radiation and chemotherapy) used to treat other cancers or medical conditions and administered within 12 months prior to signing informed consent. Use of hydroxyurea or emergent leukapheresis (for cytoreduction of highly elevated white blood cell counts) is permissible. Those AML patients who initially receive treatment with all-trans retinoic acid (ATRA) for presumptive diagnosis of APL but if APL is ruled out in final pathology will be eligible for the study.
• Prior history of treatment with recombinant thrombopoietin (TPO) or TPO-receptor (R) agonists
• History of arterial or venous thrombosis \[excluding line-thrombosis\] within the last 1 year, or those with known inherited coagulopathies. Arterial or venous thrombosis includes pulmonary embolism, deep vein thrombosis of both upper \[excluding line-thrombosis\] and lower extremities, coronary artery disease managed medically or requiring intervention (percutaneous stent placement or coronary bypass surgery), cerebrovascular accident (for transient ischemic attacks clinical documentation is required), or involvement of other organs (such as hepatic, renal, spleen or other sites).
• Evidence of fibrosis on bone marrow examination at the time of diagnosis
• Active participation in any other investigational treatment study
• Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, unstable angina or renal insufficiency (acute or chronic) on hemodialysis
• Liver enzymes (aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) can not be greater than or equal to 2.5 times the upper limits of normal (ULN)
• Total bilirubin ≥ 1.5 x ULN within 14 days of enrollment.
• Serum creatinine should be ≥ 2.5 x ULN within 14 days of enrollment
• A known immediate or delayed hypersensitivity reaction or idiosyncrasy that, in the opinion of the Medical Monitor is due to drugs chemically related to eltrombopag or excipients (e.g. mannitol)
• Known history of human immunodeficiency virus (HIV) or active hepatitis B or C
• No major surgery within 2 weeks prior to trial enrollment

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute; Leukemia, Erythroblastic, Acute

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myeloproliferative Disorders; Bone Marrow Diseases

Results Point of Contact

• Title: Dr. Sudipto Mukherjee
• Organization: Cleveland Clinic, Case Comprehensive Cancer Center

TaussigResearch@ccf.org

1-866-223-8100

Study Officials

• Sudipto Mukherjee, MD, PhD, MPH

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 26, 2014
• Study Start: August 14, 2014
• Primary Completion: October 20, 2018
• Study Completion: September 26, 2023
• Last Updated: December 1, 2021
• Results First Posted: November 24, 2020

Record last verified: 2021-11

Locations

US (1)