Chronic Myelogenous Leukemia Clinical Trial
Official title:
A Phase I Dose Escalation of MK0457 in Combination With Dasatinib in Patients With Chronic Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Verified date | January 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will evaluate MK0457 in combination with Dasatinib in patients with Chronic Myelogenous Leukemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. Efficacy and Safety will be evaluated.
Status | Terminated |
Enrollment | 3 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) - Patients must be at least 3 months from the start of dasatinib therapy and are currently receiving dasatinib therapy for CML or Ph+ ALL and be evaluable for hematologic response prior to entering the study - Patient is able to be treated with a 70 mg bid dose of dasatinib without significant toxicity at the time of study entry - Patients with active CNS disease are included and may be treated concurrently with intrathecal therapy as per institutional standards Exclusion Criteria: - Patient has had treatment with any anti-leukemia therapy (investigational or approved) other than dasatinib during the preceding 3 months. Pheresis or hydroxyurea treatment in the preceding 3 months will not exclude patients from eligibility - Patient has unresolved more than or equal to grade 2 clinically significant toxicity attributed to dasatinib at the time of study entry - Patient has known hypersensitivity to the components of study drug or its analogs - Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study - Patient has symptomatic ascites, pericardial or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible - Patient has had prior radiation therapy to more than 10% of the bone marrow; patients must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy - Patient has a LVEF <40% by multigated radionucleotide angiography (MUGA) or echocardiography |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Okabe S, Tauchi T, Ohyashiki K. Efficacy of MK-0457 and in combination with vorinostat against Philadelphia chromosome positive acute lymphoblastic leukemia cells. Ann Hematol. 2010 Nov;89(11):1081-7. doi: 10.1007/s00277-010-0998-x. Epub 2010 Jun 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics, Safety, Tolerability | 28 Days | Yes | |
Secondary | Pharmacodynamics, Hematologic Response, Cytogenetic Response, Molecular Response, Response Durability | 28 Days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05088356 -
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
|
Phase 1 | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Completed |
NCT02592447 -
Cognitive Behavioral Intervention for Targeted Therapy Fatigue (CBT-TTF) Intervention
|
N/A | |
Withdrawn |
NCT04282174 -
CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies
|
Phase 2 | |
Terminated |
NCT01397734 -
Arsenic Trioxide and Tyrosine Kinase Inhibitors for Chronic Myelogenous Leukemia (CML)
|
Phase 1 | |
Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
Withdrawn |
NCT01011998 -
A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)
|
Phase 2 | |
Completed |
NCT00378534 -
Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
|
Phase 2 | |
Completed |
NCT00098033 -
Investigation of Clofarabine in Acute Leukemias
|
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 | |
Completed |
NCT02581007 -
Reduced Intensity Conditioning Transplant Using Haploidentical Donors
|
Phase 2 | |
Terminated |
NCT03547154 -
Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)
|
Phase 2/Phase 3 | |
Terminated |
NCT02709083 -
Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
|
Phase 2 | |
Terminated |
NCT02145039 -
Reduced Intensity Conditioning and Haploidentical Related Bone Marrow for Patients With Hematologic Diseases
|
N/A | |
Terminated |
NCT02146846 -
Population Pharmacokinetics of Imatinib in CML Patients in Iran
|
N/A | |
Active, not recruiting |
NCT01036009 -
A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies
|
Phase 2 | |
Completed |
NCT00990587 -
Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy
|
Phase 1 | |
Terminated |
NCT00594308 -
In-Vivo Activated T-Cell Depletion to Prevent GVHD
|
N/A | |
Completed |
NCT00493181 -
Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients
|
Phase 2 | |
Completed |
NCT00081926 -
Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
|
Phase 4 |