Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Phase I/II Study of Tipifarnib [Zarnestra, Farnesyltransferase Inhibitor R115777 (NSC 702818)] in Patients With Myeloproliferative Disorders
This phase 1-2 trial studies the side effects and how well tipifarnib works in treating patients with chronic myeloid leukemia, chronic myelomonocytic leukemia, or undifferentiated myeloproliferative disorders. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
- To describe the toxicities of R115777 (tipifarnib) in adult patients with
myeloproliferative disorders.
- To assess hematologic responses, including changes in white blood cell count and
erythroid responses.
SECONDARY OBJECTIVES:
- To assess bone marrow cytogenetic responses to R115777.
- To analyze for the presence of neuroblastoma (N)/Kirsten rat sarcoma viral oncogene
homolog (K-Ras) mutations in patient bone marrow samples.
- To analyze the effect of R115777 on Ras /DnaJ (Hsp40) homolog, subfamily A, member
1(HDJ-2) farnesylation in patient bone marrow/peripheral blood mononuclear cells.
- To analyze the effect of R115777 on mitogen-activated protein (MAP) kinase activation in
patient bone marrow mononuclear cells.
- To perform colony forming unit granulocyte-macrophage (CFU-GM) cytotoxicity assays using
patients' hematopoietic cells with R115777.
OUTLINE:
Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Treatment repeats
every 28 days for up to 4 courses in the absence of disease progression or unacceptable
toxicity. Patients achieving a good hematologic response may continue treatment at the
discretion of the treating physician.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT04093570 -
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
|
Phase 2 | |
| Active, not recruiting |
NCT03289910 -
Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
|
Phase 2 | |
| Recruiting |
NCT06159491 -
Pacritinib in CMML
|
Phase 1/Phase 2 | |
| Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
| Recruiting |
NCT01133886 -
Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure
|
Phase 2 | |
| Completed |
NCT01169012 -
PK Study of Oral and IV Clofarabine in High Risk Myelodysplasia+Acute Leukemias
|
Phase 1 | |
| Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
| Terminated |
NCT00509249 -
Aflibercept in Treating Patients With Myelodysplastic Syndromes
|
Phase 2 | |
| Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
| Terminated |
NCT00387426 -
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
|
Phase 2 | |
| Completed |
NCT00171912 -
Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes
|
Phase 2 | |
| Completed |
NCT00096122 -
Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT00052520 -
Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03683433 -
Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation
|
Phase 2 | |
| Recruiting |
NCT04980404 -
Inqovi Maintenance Therapy in Myeloid Neoplasms
|
Phase 1 | |
| Active, not recruiting |
NCT03588078 -
Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT06085638 -
Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myelomonocytic Leukemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03999723 -
Combining Active and Passive DNA Hypomethylation
|
Phase 2 | |
| Terminated |
NCT00852709 -
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias
|
Phase 1 |