Chronic Myelogenous Leukemia Clinical Trial
Official title:
Phase II "Proof of Concept" Study of TALL-104 (MHC Non-Restricted Cytotoxic T-Cell Line) and Imatinib Mesylate (Gleevec) in Chronic Myelogenous Leukemia in Chronic Phase
Objectives:
- To determine the response rate and duration of response with combination of TALL-104
cells and imatinib mesylate (IM) therapy in patients with chronic myelogenous leukemia
in chronic phase, that have not achieved, or have lost, adequate response to IM.
- To determine the toxicity of the combination of TALL-104 cells and IM therapy in this
patient population.
Imatinib mesylate is designed to block the enzyme that is believed to be responsible for
starting the type of leukemia patient has. TALL-104 cells are cells of the immune system
that have been obtained from a patient with leukemia and then processed in the laboratory to
try to make them able to kill leukemia cells.
If found to be eligible to take part in this study, patient will continue receiving imatinib
mesylate by mouth at the same schedule and dose patient had been receiving before entering
the study. Patient will receive TALL-104 cells through a needle in their vein over 1 hour on
Days 1-4, and then again on Days 7, 10, 14, 17, and 21 of the cycle. The cycle will last 28
days.
Blood (about 1 tablespoon) will be drawn every week for the first 4 weeks, then every 2-4
weeks for 2 months, then every 4-6 weeks until 6 months, and then every 3-6 months for
routine tests and to check for any effect on organs.
Patient will have follow-up visits at 1 month, 3 months, 6 months, and at least annually for
2 years, and then at least every 5 years from then on for the rest of your life. Blood
(about 1 teaspoon) will be drawn to check the status of the disease. An additional 1
tablespoon will also be collected and stored to be analyzed in case unexpected side effects
occur after receiving therapy. If patient experiences certain side effects, more blood may
need to be drawn and more tests performed based on the side effects experienced.
Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 | |
Withdrawn |
NCT01011998 -
A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)
|
Phase 2 | |
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 | |
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 | |
Terminated |
NCT00500006 -
A Phase I Dose Escalation Combination Study in Patients With Chronic Myelogenous Leukemia (CML) and Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)(0457-009)(TERMINATED)
|
Phase 1 | |
Completed |
NCT00493181 -
Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients
|
Phase 2 |