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Donor Peripheral Blood Stem Cell Transplant and Pretargeted Radioimmunotherapy in Treating Patients With High-Risk Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome

NCT00988715 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-08-30

No results posted yet for this study

Summary

This phase I trial studies pretargeted radioimmunotherapy and donor peripheral blood stem cell transplant employing fludarabine phosphate and total-body irradiation (TBI) to treat patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Giving chemotherapy drugs, such as fludarabine phosphate, and TBI before a donor peripheral blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies can be combined with fludarabine phosphate and TBI to find cancer cells and kill them without harming normal cells. Pretargeted radioimmunotherapy (PRIT) allows for further improved targeting of tumor cells over standard directly labeled antibodies.

Conditions

  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Previously Treated Myelodysplastic Syndrome
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Anemia With Excess Blasts
  • Refractory Cytopenia With Multilineage Dysplasia
  • Refractory Cytopenia With Multilineage Dysplasia and Ringed Sideroblasts
  • Secondary Acute Myeloid Leukemia

Interventions

BIOLOGICAL

Pretargeted Radioimmunotherapy

Antibody-streptavidin conjugate and radiolabeled DOTA-biotin, each given IV

DRUG

Cyclosporine

Given IV

DRUG

Mycophenolate Mofetil

Given PO

RADIATION

Total-Body Irradiation

Undergo total-body irradiation

PROCEDURE

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Undergo peripheral blood stem cell transplant

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo peripheral blood stem cell transplant

DRUG

Fludarabine Phosphate

Given IV

OTHER

Pharmacological Study

Correlative studies

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Brenda Sandmaier · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-21
Primary Completion
2015-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988715 on ClinicalTrials.gov