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Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

NCT02960646 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-02-16

No results posted yet for this study

Summary

This pilot phase I trial studies the side effects of engineered donor stem cell transplant in treating patients with hematologic malignancies. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Using T cells specially selected from donor blood in the laboratory for transplant may stop this from happening.

Conditions

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Aplastic Anemia
  • Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Chronic Myelomonocytic Leukemia
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Lymphoblastic Lymphoma
  • Myelodysplastic Syndrome
  • Myeloproliferative Neoplasm
  • Plasma Cell Myeloma
  • Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • Recurrent Hodgkin Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Plasma Cell Myeloma
  • Therapy-Related Myelodysplastic Syndrome

Interventions

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Melphalan

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo CD45RA depleted peripheral blood stem cell transplantation

BIOLOGICAL

Rituximab

Given IV

DRUG

Tacrolimus

Given IV or PO

RADIATION

Total-Body Irradiation

Undergo TBI

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Samer Srour · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-18
Primary Completion
2023-02-13
Completion
2023-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02960646 on ClinicalTrials.gov