Chronic Myelogenous Leukemia Clinical Trial
Official title:
A Phase I Study of PR1-Specific Cytotoxic T-Lymphocyte Infusion for Patients With Recurrent CML After Allogeneic Hematopoietic Transplantation
Primary Objective:
To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes
(PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after
allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor.
Secondary Objectives:
1. To evaluate the immunological response following PR1-CTL treatment
2. To evaluate the clinical efficacy by determining clinical, cytogenetic and molecular
response rates within 6 months
Before treatment starts, you will have a complete physical exam, including blood (about 2
tablespoons) tests. You will have a chest x-ray and bone marrow will be collected. To
collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and
a small amount of bone marrow is withdrawn through a large needle. Women who are able to
have children must have a negative blood pregnancy test.
You will be treated with donor immune cells (T lymphocytes) that will specifically target
certain leukemia cells in your body. Each participant will receive two doses of donor cells,
60 days apart. The second dose will be given 60 days after the first dose, at a higher dose
level, as long as no serious side effects occur after the first dose and there is still
disease present. Four dose levels of PR1-specific T lymphocytes will be considered. Up to 30
patients will be treated in cohorts of 3, starting at the lowest dose level, and not
skipping an untried dose level when escalating. The trial will be stopped early if the
lowest dose level is found to be unacceptably toxic.
These cells will be given on an outpatient basis. After each donor cell infusions, you will
be followed once a week in the outpatient clinic for at least 1 month and then every 3
months for at least one year. You will have routine blood (about 2 tablespoons) and urine
tests at these visits. Participants experiencing side effects from their leukemia or
leukemia treatment may need to be hospitalized earlier.
You will also receive several other medications to help decrease the risk of infections
while your immune system is weak. These include preventative antibiotics, antiviral drugs,
and antifungal drugs.
Bone marrow samples will be taken before the second cell infusion, and then 8 weeks, 12
weeks, 6 months and 1 year after the second cell infusion.
This is an investigational study. A total of up to 30 patients will be take part in this
study. All will be enrolled at UTMDACC.
;
Endpoint Classification: 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 |