Thalidomide in Treating Patients With Myelofibrosis

Status Completed

Clinical Trial Summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have myelofibrosis. Thalidomide may stop the growth of myelofibrosis by stopping blood flow to the cancer cells.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To investigate whether thalidomide, a potent inhibitor of angiogenic and fibrogenic growth factors, is an effective therapeutic agent in patients with MMM. Specifically, to assess whether thalidomide improves anemia and/or organomegaly in patients with MMM.

II. To assess the effects of thalidomide on the myelofibrotic stroma with respect to microvascular architecture and angiogenesis, collagen and reticulin deposition, and the expression of the mediating growth factors bFGF, TGF-b, and PDGF, and their respective receptors.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive 1 additional year of therapy.

Patients are followed every 6 months until 5 years from study entry. ;

Study Design

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

Related Conditions & MeSH terms

Primary Myelofibrosis

Clinical Trial Details

NCT number	NCT00015821
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 2
Start date	May 2000

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01178281` - Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence	Phase 3
Not yet recruiting	`NCT06327100` - Open Label Phase 2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)	Phase 2
Active, not recruiting	`NCT00095784` - Decitabine in Treating Patients With Myelofibrosis	Phase 2
Recruiting	`NCT02897297` - Myeloproliferative Neoplastic Diseases Observatory From Brest
Terminated	`NCT02091752` - A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)	Phase 2
Completed	`NCT01445769` - Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis	Phase 2
Completed	`NCT01233921` - Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer	N/A
Unknown status	`NCT01298934` - LBH589 (Panobinostat) for the Treatment of Myelofibrosis	Phase 1/Phase 2
Terminated	`NCT00387426` - Sunitinib in Treating Patients With Idiopathic Myelofibrosis	Phase 2
Completed	`NCT05044026` - A Prospective, Two-arm, Non-interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis
Active, not recruiting	`NCT03952039` - An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib	Phase 3
Active, not recruiting	`NCT02530619` - Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia	N/A
Completed	`NCT01588015` - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant	Phase 1
Completed	`NCT01731951` - Imetelstat Sodium in Treating Participants With Primary or Secondary Myelofibrosis	Phase 2
Not yet recruiting	`NCT06468033` - P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk	Phase 3
Completed	`NCT01371617` - A Phase 2 Study With IPI-926 in Patients With Myelofibrosis	Phase 2
Active, not recruiting	`NCT02251821` - JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis	Phase 2
Active, not recruiting	`NCT04446650` - A Study of Fedratinib in Japanese Subjects With DIPSS (Dynamic International Prognostic Scoring System)- Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)	Phase 1/Phase 2
Completed	`NCT01981850` - A Phase 2 Study of RO7490677 In Participants With Myelofibrosis	Phase 2
Withdrawn	`NCT04283526` - Study of Select Combinations in Adults With Myelofibrosis	Phase 1