Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases

Summary

RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells and prepares the patient's bone marrow for the stem 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an umbilical cord blood transplant for hematologic cancer.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Myelofibrosis
• MDS
• Refractory Anemia
• Chronic Lymphocytic Leukemia
• Prolymphocytic Leukemia
• Non-Hodgkin's Lymphoma
• Leukemia
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndromes

Interventions

BIOLOGICAL

filgrastim

All patients will receive G-CSF 5 mcg/kg/day intravenously(IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10\^9/L for three consecutive days.

DRUG

cyclophosphamide

Cyclophosphamide to be administered with high volume fluid flush and mesna (MT(S) 9006) at 10:00am, or per institutional routine, on days-7 and -6 after fludarabine. Cyclophosphamide 60mg/kg/day intravenous (IV) x 2 days, total dose 120 mg/kg (days -7 and -6) Dosing is calculated based on Actual BodyWeight (ABW) unless ABW \> 30 kg above Ideal BodyWeight (IBW), in which case the dose should be computed using adjusted body weight.

DRUG

cyclosporine

Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of \> 200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children \< 40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours.

DRUG

fludarabine phosphate

Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -8 to -6);

DRUG

mycophenolate mofetil

All patients will begin mycophenolate mofetil (MMF) on day -3. Patients ≥ 40 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses (every 12 or 8 hours). Pediatric patient (\<40 kilograms) will receive MMF at the dose of 15 mg/kg three times a day.

PROCEDURE

umbilical cord blood transplantation

The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter.

RADIATION

total-body irradiation

The recommended TBI is 165 cGy given twice daily for a total dose of 1320 cGy (days -4 to -1).

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• Claudio G. Brunstein, MD, PhD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-07-28

Primary Completion

2019-07-29

Completion

2019-11-22

Countries

• United States

Study Locations