Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms

Summary

This clinical trial studies how well early stem cell transplantation works in treating patients with high-grade myeloid neoplasms that has come back after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as filgrastim, cladribine, cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor peripheral blood cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Early stem cell transplantation may result in more successful treatment for patients with high-grade myeloid neoplasms.

Conditions

• Blasts 10 Percent or More of Bone Marrow Nucleated Cells
• Chronic Myelomonocytic Leukemia-2
• High Grade Malignant Neoplasm
• Myelodysplastic Syndrome
• Myelodysplastic Syndrome With Excess Blasts-2
• Myeloid Neoplasm
• Previously Treated Myelodysplastic Syndrome
• Recurrent Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia

Interventions

DRUG

Cladribine

Given IV

DRUG

Cyclosporine

Given PO

DRUG

Cytarabine

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Fludarabine Phosphate

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic hematopoietic stem cell transplantation

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Melphalan

Given IV

DRUG

Mitoxantrone Hydrochloride

Given IV

DRUG

Mycophenolate Mofetil

Given PO

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Sirolimus

Given PO

RADIATION

Total-Body Irradiation

Undergo TBI

DRUG

Melphalan Hydrochloride

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Mary-Elizabeth Percival · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-22

Primary Completion

2020-03-01

Completion

2020-07-01

Countries

• United States

Study Locations