Trial record 15 of 345 for:    "Myelofibrosis"

A Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00287261
First received: February 2, 2006
Last updated: January 3, 2011
Last verified: April 2007
  Purpose

In this trial, the question is addressed if zoledronic acid (Zometa, Novartis Pharma)could be of clinical benefit for patients with myelofibrosis and myeloid metaplasia (MMM).


Condition Intervention Phase
Myelofibrosis
Myeloid Metaplasia
Drug: zoledronic acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multicentre Phase II Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • effect of monthly zoledronic acid infusion on hemoglobin level and spleen size [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • red blood cell transfusion need [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • performance status [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • constitutional symptoms [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • leukocyte count [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • thrombocyte count [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • serum LDH [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • bone marrow histology [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • safety of zometa infusions [ Time Frame: until progression or death ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: February 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zometa
3-weekly infusion of zometa (zoledronic acid) 4 mg
Drug: zoledronic acid
4 mg IV every 3 weeks for 36 weeks
Other Name: zoledronic acid

Detailed Description:

This is a prospective, multicentre phase II study in adult patients with documented MMM and requiring therapy for their disease. Patients will be treated every 3 weeks with 4 mg zoledronic acid (Zometa), administered by a 15 min. intravenous infusion. Study duration is 36 weeks (12 infusions). After the study it is recommended to continue treatment until disease progression, or the occurrence of unacceptable treatment-related toxicity.

Objectives of the trial are:

Primary objectives: the effect of monthly infusion of zoledronic acid 4 mg on:

hemoglobin level, spleen size

Secondary objectives the effect of monthly infusion of zoledronic acid 4 mg on: red blood cell transfusion need performance status constitutional symptoms leukocyte count thrombocyte count bone marrow fibrosis serum LDH

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

male or female and at least 18 years-of-age histologically confirmed diagnosis of myelofibrosis with myeloid metaplasia (MMM). This includes patients with agnogenic myeloid metaplasia (also known as idiopathic myelofibrosis) and patients with a preceding history of polycythemia vera or essential thrombocytemia (also known as post-polycytemic myelofibrosis). (see Appendix A) patients with low, intermediate and high risk disease categories (following the Dupriez score) may be included presence of measurable, clinically relevant disease manifestations (especially for low risk patients) ECOG performance status of 0, 1 or 2 life expectancy of at least 3 months Women of childbearing potential must use a medically acceptable form of contraception during the study and must have a negative urine or serum pregnancy test within 7 days of randomization written informed consent

Exclusion Criteria:

diseases associated with secondary myelofibrosis, such as metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7 disease or acute panmyelosis with myelofibrosis) presence of the chromosomal translocation t(9:22) or molecular BCR/ABL rearrangement as detected by RT-PCR in bone marrow or peripheral blood any anti-myelofibrosis drug therapy during the last 4 weeks. This includes chemotherapy, androgens, steroids, thalidomide, hematopoietic growth factors or any other investigational drug patients that have received bisphosphonates in the previous 3 months known allergy or intolerance to bisphosphonates abnormal renal function as evidenced by: a calculated creatinine clearance < 30 ml/min (creatinine clearance (CrCl) is calculated using the Cockcroft and Gault formula) (see Appendix F) corrected serum calcium < 8.0 mg/dL . Corrected serum calcium (mg/dl) = measured calcium (mg/dl) + 0.8*[4 - patient serum albumin (g/dl)] patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including: uncontrolled infections uncontrolled type 2 Diabetes Mellitus diseases with influence on bone metabolism such as Paget's disease or uncontrolled thyroid or parathyroid dysfunction cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up current active dental problems including infection of the teeth or jawbone (maxilla or mandibula); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) patients with a history of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative patients treated with any systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days pregnant or breast feeding females

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287261

Locations
Australia, Queensland
Cancer Care Services
Brisbane, Queensland, Australia, 4029
Belgium
University Hospital Leuven
Leuven, Belgium, 3000
France
Hopital Avicenne and Paris 13 University
Bobigny, France, 93000
Germany
Medizinische Klinik Kiel
Kiel, Germany, 24105
Israel
RAMBAM Medical Center and Technion
Haifa, Israel, 31096
Spain
Hospital Rafael éndez
Murcia, Lorca, Spain, 30800
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Michel Delforge, MD, PhD University Hospital Leuven, Belgium
  More Information

No publications provided

Responsible Party: Prof Dr Michel Delforge, University Hospital Leuven Belgium
ClinicalTrials.gov Identifier: NCT00287261     History of Changes
Other Study ID Numbers: CZOL446G2422
Study First Received: February 2, 2006
Last Updated: January 3, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by University Hospital, Gasthuisberg:
myelofibrosis
D009191

Additional relevant MeSH terms:
Primary Myelofibrosis
Metaplasia
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014