Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide — DRUG
  Given IV
• Filgrastim — BIOLOGICAL
  Given SC
• Fludarabine Phosphate — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Melphalan — DRUG
  Given IV
• Peripheral Blood Stem Cell Transplantation — PROCEDURE
  Undergo CD45RA depleted peripheral blood stem cell transplantation
• Rituximab — BIOLOGICAL
  Given IV
• Tacrolimus — DRUG
  Given IV or PO
• Total-Body Irradiation — RADIATION
  Undergo TBI

Study Details

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.

Key Dates

Start date

Jan 18, 2017

Status verified

Feb 2023

Primary completion

Feb 13, 2023

Completion

Feb 13, 2023

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (peripheral blood stem cell transplantation)
  Patients receive melphalan IV over 30 minutes on day -6 and fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo TBI on day -2 and CD45RA depleted peripheral blood stem cell transplantation on day 0. Patients also receive cyclophosphamide IV over 3 hours on days 3-4. Beginning on day 5, patients receive tacrolimus IV for 2 weeks and PO for at least 4 months. Beginning on day 7, patients receive filgrastim SC daily. Patients with CD20 positive lymphoma may receive rituximab IV on days -13, -6, 1, and 8.

Primary Outcome Measure

Incidence of treatment failure defined as primary graft failure, grade 3-4 acute graft versus host disease (aGVHD), or non-relapse mortality [ Time Frame: Up to 100 days ]

Locations (1)

Find similar trials in Houston, TX

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