Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Phase I/II Study of Adoptive Immunotherapy With CD8+ WT1-Specific CTL Clones for Patients With Advanced MDS, CML, AML or ALL After Allogeneic Hematopoietic Stem Cell Transplant
This phase I/II trial is studying the side effects of biological therapy and to see how well it works in treating patients with advanced myelodysplastic syndrome, chronic myeloid leukemia, acute myeloid leukemia, or acute lymphoblastic leukemia. Biological therapies, including immunotherapy, can potentially be used to stimulate the immune system and stop cancer cells from growing. Immunotherapy given to patients who have undergone donor stem cell transplantation may be a way to eradicate remaining cancer cells
PRIMARY OBJECTIVES:
I. To determine the safety and potential toxicities associated with infusing donor CD8+
cytotoxic T lymphocyte (CTL) clones specific for Wilms' tumor (WT1) in patients who have
relapsed or at a high risk of relapse post transplant for myelodysplastic syndromes (MDS),
chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), or acute lymphoblastic
leukemia (ALL).
SECONDARY OBJECTIVES:
I. To determine the in vivo persistence of transferred T cells and assess migration to the
bone marrow, a predominant site of leukemic relapse.
II. To determine if adoptively transferred WT1-specific T cells mediate antileukemic
activity.
OUTLINE: Donors undergo leukapheresis for stem cell harvest to generate CD8-positive WT1
gene-specific CTL clones at the time of allogeneic stem cell transplantation.
After post-transplantation hematopoietic recovery, patients receive treatment for either
highest-risk disease (prophylactically) or relapsed disease.
Highest-risk disease group: Patients receive CD8-positive WT1 gene-specific CTL clones
intravenously (IV) over 1-2 hours on days 0, 14, and 28. Beginning 2-4 hours after CTL
infusion, patients receive interleukin-2 subcutaneously (SC) twice daily on days 28-42 in
the absence of unacceptable toxicity.
Relapsed-disease group: Some patients with evidence of leukemic relapse may receive standard
salvage chemotherapy prior to donor CTL infusions and then receive CD8-positive WT1
gene-specific CTL clones and interleukin-2 as in the highest-risk group.
Patients in both groups who have progressive disease after complete or partial response to
therapy may be eligible for retreatment with CD8-positive WT1 gene-specific CTL clones.
After completion of study treatment, patients are followed every 3 months for 2 years.
;
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 | |
Terminated |
NCT00509249 -
Aflibercept in Treating Patients With Myelodysplastic Syndromes
|
Phase 2 | |
Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
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 | |
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 | |
Terminated |
NCT00589316 -
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or High-Risk Myelodysplastic Syndrome
|
Phase 1 |