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P1101 in Treating Patients With Early Myelofibrosis

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Myelofibrosis; Secondary Myelofibrosis

Intervention: PEG-proline-interferon alpha-2b (Biological); Quality-of-Life Assessment (Other); Laboratory Biomarker Analysis (Other)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Ruben Mesa, Principal Investigator, Affiliation: Mayo Clinic in Arizona

Summary

This pilot phase II trial studies P1101 (polyethyleneglycol [PEG]-proline-interferon alpha-2b) in treating patients with early myelofibrosis. PEG-proline-interferon alpha-2b is a substance that can improve the body's natural response and may slow the growth of early myelofibrosis.

Clinical Details

Official title: Phase II Study of P1101 in Early Myelofibrosis

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Best overall response (CR, PR, or CI) as determined by International Working Group Criteria

Secondary outcome:

Survival time

Incidence of adverse events, as measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4)

Detailed description: PRIMARY OBJECTIVES: I. To evaluate for clinical response (complete remission [CR], partial remission [PR], or clinical improvement [CI]) as defined by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. SECONDARY OBJECTIVES: I. To evaluate the adverse event profile of P1101 in patients with myelofibrosis. II. To evaluate the tolerability of P1101 in patients with myelofibrosis. TERTIARY OBJECTIVES: I. To evaluate quality of life (QOL) and patient-reported symptoms using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) with P1101 for patients with myelofibrosis. II. To evaluate the impact of P1101 on bone marrow and histological features of myelofibrosis including cytogenetics, blast percentage, fibrosis, and janus kinase 2 (JAK2)-V617F allele burden. OUTLINE: Patients receive PEG-proline-interferon alpha-2b subcutaneously (SC) on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3-6 months for 3 years.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Evaluable myelofibrosis by IWG-MRT criteria including one or more of the following:

- Spleen >= 5 cm below the left costal margin

- MPN-SAF total symptom score (TSS) > 10 at baseline

- Hemoglobin < 10 g/dL

- Confirmed diagnosis of myelofibrosis (primary myelofibrosis or myelofibrosis

secondary to essential thrombocythemia or polycythemia vera) by World Health Organization (WHO) diagnostic criteria (3 major and 2 minor criteria: major criteria: megakaryocyte proliferation and atypia with either reticulin and/or collagen fibrosis, not meeting criteria for chronic myelogenous leukemia [CML], polycythemia vera [PV], myelodysplastic syndrome [MDS], or other myeloid neoplasm, JAK2V617F or other clonal marker or no evidence of reactive marrow fibrosis; minor criteria: leukoerythroblastosis, increased lactate dehydrogenase [LDH], anemia, palpable splenomegaly)

- Early stage myelofibrosis (MF) (low or intermediate 1 stage as defined by Dynamic

International Prognostic Scoring System [DIPSS])

- No prior treatment for myelofibrosis

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

- Platelet count >= 100,000/mm^3

- Absolute neutrophil count (ANC) >= 1000/mm^3

- Aspartate transaminase (AST) =< 2. 5 x upper limit of normal (ULN)

- Alanine aminotransferase (ALT) =< 2. 5 x ULN

- Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault

formula

- Negative pregnancy test done =< 7 days prior to registration, for women of

childbearing potential only

- Ability to complete questionnaire(s) by themselves or with assistance

- Provide informed written consent

- Willing to return to enrolling institution for follow-up

Exclusion Criteria:

- Patients who have had chemotherapy or radiation =< 2 weeks of registration

- Patients with evidence of intermediate 2 or high risk disease (according to DIPSS)

- Patients with a bone marrow biopsy with < 15% cellularity, evidence of collagen

fibrosis, or osteosclerosis (demonstrating advanced disease)

- Patients with intolerance to compounds similar to pegylated interferon alpha-2b

- Patients with evidence of >= grade 2 peripheral sensory neuropathy

- Any of the following:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate

contraception

- Co-morbid systemic illnesses or other severe concurrent disease which, in the

judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

- Immunocompromised patients or patients known to be human immunodeficiency virus (HIV)

positive and currently receiving antiretroviral therapy

- Uncontrolled simultaneous illness including, but not limited to, ongoing or active

infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of depression, or psychiatric illness/social situations that would limit compliance with study requirements

- Receiving any other investigational agent which would be considered as a treatment

for the primary neoplasm

- History of myocardial infarction =< 6 months prior to registration, or congestive

heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

- History of significant or major fundoscopic findings including, but not limited to,

retinal exudates, hemorrhage, detachment, neovascularization, papilloedema, optic atrophy, micro-aneurysm or macular changes

- Other active malignancy at time of registration; EXCEPTIONS: non-melanotic skin

cancer or carcinoma-in-situ of the cervix

Locations and Contacts

Mayo Clinic in Arizona, Scottsdale, Arizona 85259, United States; Not yet recruiting
Clinical Trials Referral Office, Phone: 855-776-0015
Ruben A. Mesa, Principal Investigator
Additional Information

Starting date: March 2015
Last updated: February 17, 2015

Page last updated: August 23, 2015

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