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Clinical Trial Summary

This phase I trial studies the side effects and best dose of rivogenlecleucel, and how well it works, in treating patients with blood cancer that has come back (recurrent) after stem cell transplant. Donor T-cell therapy (rivogenlecleucel) may help control transplant-related infections after stem cell transplant.


Clinical Trial Description

This is a dose-escalation study of rivogenlecleucel.

Each subject may receive up to 3 doses of rivogenlecleucel intravenously (IV), at intervals of no less than 28 days. Subjects meeting protocol-specified severity criteria for acute GVHD, chronic GVHD, cytokine release syndrome (CRS), prolonged aplasia, or encephalopathy will be treated with rimiducid infusion(s).

After completion of study treatment, patients are followed up every 6 months for 5 years and then annually for 10 years. ;


Study Design


Related Conditions & MeSH terms

  • Acute Bilineal Leukemia
  • Leukemia
  • Leukemia, Biphenotypic, Acute
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelomonocytic, Juvenile
  • Myelodysplastic Syndromes
  • Myelodysplastic-Myeloproliferative Diseases
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Myeloproliferative Disorders
  • Myeloproliferative Neoplasm
  • Neoplasms
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Recurrent Acute Biphenotypic Leukemia
  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Recurrent Chronic Myelomonocytic Leukemia
  • Recurrent Myelodysplastic Syndrome

NCT number NCT03807063
Study type Interventional
Source Fred Hutchinson Cancer Research Center
Contact
Status Withdrawn
Phase Phase 1
Start date January 2, 2020
Completion date December 31, 2021

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