Pegasys® in Patients With Myeloproliferative Diseases

NCT00452023 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: DM03-0109NCI-2012-01474
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to see if Pegasys (IFN-alpha2a) can help to control the disease in patients with ET, PV, AMM/MF, and Ph-negative CML. The safety of this treatment will also be studied.

Conditions

Myeloproliferative Disorders

Keywords

Myeloproliferative Disorders; Essential Thrombocythemia; Polycythemia Vera; Pegasys; IFN-alpha2a; Pegylated-Interferon Alpha-2A; PEG-IFNa-2a

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Complete Response (CR) or Partial Response (PR)

  CR = Reduction of PLT to \<440x109/l and disappearance of thromboembolic events, without the use of anagrelide or hydroxyurea PR = Reduction of PLT by 50% but still \>440x109/l or reduction of thromboembolic events by 50%, without the use of anagrelide or hydroxyurea

  Up to 18 years

Study Arms (5)

IFN-alpha2a 90 Microgram (mcg) weekly

EXPERIMENTAL

Starting dose 90 microgram (mcg) injection under the skin once a week.

Drug: IFN-alpha2a

IFN-alpha2a 450 Microgram (mcg) weekly

EXPERIMENTAL

Starting dose 450 microgram (mcg) injection under the skin once a week.

Drug: IFN-alpha2a

IFN-alpha2a 360 Microgram (mcg) weekly

EXPERIMENTAL

Starting dose 360 microgram (mcg) injection under the skin once a week.

Drug: IFN-alpha2a

IFN-alpha2a 270 Microgram (mcg) weekly

EXPERIMENTAL

Starting dose 270 microgram (mcg) injection under the skin once a week.

Drug: IFN-alpha2a

IFN-alpha2a 180 Microgram (mcg) weekly

EXPERIMENTAL

Starting dose 180 microgram (mcg) injection under the skin once a week.

Drug: IFN-alpha2a

Interventions

IFN-alpha2a DRUG

Starting dose 90 microgram (mcg) injection under the skin once a week

Also known as: Pegylated-Interferon Alpha-2A, PEG-IFNa-2a, Pegasys

IFN-alpha2a 180 Microgram (mcg) weekly; IFN-alpha2a 270 Microgram (mcg) weekly; IFN-alpha2a 360 Microgram (mcg) weekly; IFN-alpha2a 450 Microgram (mcg) weekly; IFN-alpha2a 90 Microgram (mcg) weekly

Eligibility Criteria

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

You may qualify if:

• Following diagnoses: --ET: Patients with PLT \> 600 x10 9 /l documented in the past 12 months; hyperplasia of marrow megakaryocytes in the absence of identifiable cause of thrombocytosis and in the absence of Ph chromosome. Patients with ET and lower PLT will be eligible if attributable to prior ET therapy. --PV: Patients should have Hb \>/= 15g/dl (except if patient is having phlebotomies done) and documented past diagnosis.
• Performance status \</= 2 (ECOG scale).
• Age greater than 18 years since disease is extremely rare in younger age group.
• Adequate liver function: total bilirubin of \</= 2.0 mg/dl (except for patients with Gilbert's Syndrome) and AST (SGOT) or ALT (SGPT) \< 3 X ULN (or \< 5 X ULN if considered due to tumor), and renal function (serum creatinine \</= 2.0 mg/dl).
• Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the M.D. Anderson Cancer Center. The only acceptable consent form is the one approved by the M.D. Anderson Cancer Center IRB.
• Willingness and ability to comply with the requirements of the protocol for the duration of the study.
• Patients must have been off chemotherapy for 1 week prior to beginning Pegasys and have recovered from the toxic effects of that therapy. Patients may have received hydroxyurea or anagrelide immediately before study entry, and may continue into therapy if treating physician determines this is in the best interest of the patient.

You may not qualify if:

• Pregnant or lactating women.
• Patients with prior history of another malignancy or concurrent malignancy, except for the following: basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies if the patient is disease free \>3 years.
• Patients with history of ischemic retinopathy.
• Patients with history of severe cardiac disease: NYHA Functional Class III or IV, myocardial infarction within 6 months, uncontrolled ventricular tachyarrhythmias or unstable angina.
• Patients with history of medically significant psychiatric disease if not controlled, especially endogenous depression (does not include reactive depression post-cancer diagnosis), psychosis and bipolar disease.
• Patients with seizure disorders requiring anticonvulsant therapy.
• Patients with known infection with HBV, HIV, or other active systemic infection.
• Patients with known autoimmune disease except for rheumatoid arthritis.
• Patients with renal disease on hemodialysis.
• Patients taking continuous or chronic high-dose systemic steroids; if discontinued, there must be a minimum washout period of one month before study drug is begun.
• Patients with known hypersensitivity to PEG-IFN alpha-2a or its components.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Masarova L, Yin CC, Cortes JE, Konopleva M, Borthakur G, Newberry KJ, Kantarjian HM, Bueso-Ramos CE, Verstovsek S. Histomorphological responses after therapy with pegylated interferon alpha-2a in patients with essential thrombocythemia (ET) and polycythemia vera (PV). Exp Hematol Oncol. 2017 Nov 9;6:30. doi: 10.1186/s40164-017-0090-5. eCollection 2017.

  PMID: 29152412 DERIVED

• Masarova L, Patel KP, Newberry KJ, Cortes J, Borthakur G, Konopleva M, Estrov Z, Kantarjian H, Verstovsek S. Pegylated interferon alfa-2a in patients with essential thrombocythaemia or polycythaemia vera: a post-hoc, median 83 month follow-up of an open-label, phase 2 trial. Lancet Haematol. 2017 Apr;4(4):e165-e175. doi: 10.1016/S2352-3026(17)30030-3. Epub 2017 Mar 11.

  PMID: 28291640 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Myeloproliferative Disorders; Thrombocythemia, Essential; Polycythemia Vera

Interventions

Interferon alpha-2; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Lucia Masarova MD/Assistant Professor
• Organization: The University of Texas MD Anderson Cancer Center

LMasarova@mdanderson.org

832-750-4211

Study Officials

• Lucia Masarova, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2007
• First Posted: March 26, 2007
• Study Start: April 7, 2005
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-12

Locations

US (1)