Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Phase II Trial of Liposomal Daunorubicin (Daunoxome) and SU5416 (NSC 696819) in Patients With AML, RAEB, RAEB-T or CMML in Transformation Refractory to One Course of Induction Chemotherapy
Phase I/II trial to study the effectiveness of liposomal daunorubicin and SU5416 in treating patients who have hematologic cancer that has not responded to initial therapy. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. SU5416 may stop the growth of hematologic cancer by stopping blood flow to the cancer
OBJECTIVES:
I. Determine the maximum tolerated dose of SU5416 when administered with daunorubicin
liposomal in patients with acute myeloid leukemia, refractory anemia with excess blasts
(RAEB), RAEB in transformation, or chronic myelomonocytic leukemia not in complete remission
21-50 days after one course of induction chemotherapy.
II. Determine the efficacy of this regimen in these patients. III. Determine the qualitative
and quantitative toxicities of this regimen in these patients.
OUTLINE: This is a dose escalation study of SU5416.
Patients receive daunorubicin liposomal IV over 6 hours on days 1-3 and SU5416 IV twice a
week for 2 months. The second course is administered for 1 month, then treatment continues
every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicities.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 1 year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
| Completed |
NCT01169012 -
PK Study of Oral and IV Clofarabine in High Risk Myelodysplasia+Acute Leukemias
|
Phase 1 | |
| Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
| Terminated |
NCT00509249 -
Aflibercept in Treating Patients With Myelodysplastic Syndromes
|
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 |