Clinical Trials Logo
  1. Home
  2. Hematological Malignancies
  3. NCT00438178

Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies

Hematological Malignancies Clinical Trial

Official title:
A Phase I Study of Obatoclax Mesylate (GX15-070MS) in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML)in Myeloid Blast Phase, Myelofibrosis, Previously-Treated Chronic Lymphocytic Leukemia (CLL), or Aplastic Anemia

Clinical Trial Summary

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

Clinical Trial Description

This is a multi-center, open-label, Phase I study of obatoclax administered every 2-week or weekly cycles, or as a Prolonged Infusion every 2 to 3 weeks to patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML)in Myeloid Blast Phase, Myelofibrosis, Previously-Treated Chronic Lymphocytic Leukemia (CLL), or Aplastic Anemia. Due to the PK/PD sampling schedule Cycle 1 will require overnight hospitalization. For the following cycles treatment may be administered on an outpatient basis but is at the discretion of the investigator. No investigational or commercial agents or therapies other than those described within the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from hematological malignancies are allowed. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00438178
Study type Interventional
Source Teva Pharmaceutical Industries
Contact
Status Completed
Phase Phase 1
Start date October 2005
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03248479 - Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies Phase 1
Recruiting NCT05454241 - CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies Phase 2
Recruiting NCT06041815 - Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
Active, not recruiting NCT05005442 - A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) Phase 2
Recruiting NCT02300571 - Observational Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant N/A
Active, not recruiting NCT01428973 - Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens Phase 2
Terminated NCT00506948 - Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD) Phase 2
Completed NCT01162096 - Reduced Intensity Haploidentical Transplant for Hematological Malignancies Phase 1/Phase 2
Completed NCT00379587 - Rituximab for Prevention of Chronic GVHD Phase 1/Phase 2
Active, not recruiting NCT04557098 - A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Phase 2
Recruiting NCT04283097 - Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects Phase 1
Completed NCT03067155 - CMV Specific T Cell Therapy After Allogeneic Stem Cell Transplantation. Phase 2
Completed NCT01725555 - A Study to Assess the Effect of Food on the Bioavailability of the IGF-1R Inhibitor AXL1717 in Patients With Advanced Malignant Tumors Phase 1
Completed NCT03711604 - Compassionate Use Study of Tenalisib (RP6530) Phase 1/Phase 2
Withdrawn NCT01168882 - Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies Phase 1
Completed NCT01246206 - Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT Phase 2
Completed NCT01172132 - The Use of Intensive Care in Critically Ill Cancer Haematological Patients: "TRIAL-OH" N/A
Completed NCT00506402 - A Phase 1 Study of MKC-1 in Patients With Refractory Hematologic Malignancies Phase 1
Active, not recruiting NCT00163644 - RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT N/A
Completed NCT01063647 - Dose-range Finding Treosulfan-based Conditioning Phase 1/Phase 2