Recruitment

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