Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Loss of Chromosome 17p
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia in Remission
- Hematopoietic Cell Transplantation Recipient
- Recurrent Hematologic Malignancy
- JAK2 Gene Mutation
- Refractory Diffuse Large B Cell Lymphoma
- Mantle Cell Lymphoma
- Minimal Residual Disease
- Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
- Myelodysplastic Syndrome
- Non Hodgkin Lymphoma
- Therapy-Related Myelodysplastic Syndrome
- Plasma Cell Myeloma
- RAS Family Gene Mutation
- Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Recurrent Diffuse Large B-Cell Lymphoma
- Therapy-Related Acute Myeloid Leukemia
- TP53 Gene Mutation
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the toxicity associated with the administration of irradiated haploidentical cells (IHC) to patients with high-risk hematologic malignancies. SECONDARY OBJECTIVES: I. To determine if there is evidence of disease response associated with IHC. TERTIARY OBJECTIVES: I...
PRIMARY OBJECTIVES: I. To determine the toxicity associated with the administration of irradiated haploidentical cells (IHC) to patients with high-risk hematologic malignancies. SECONDARY OBJECTIVES: I. To determine if there is evidence of disease response associated with IHC. TERTIARY OBJECTIVES: I. To determine if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous hematopoietic stem cell transplantation (HSCT), patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. COHORT II: Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. After completion of study treatment, patients will be followed up within 8 weeks.
Tracking Information
- NCT #
- NCT03272633
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Roger Strair Rutgers Cancer Institute of New Jersey