Busulfan and Cyclophosphamide Followed By ALLO BMT

Summary

This is a treatment guideline to allow routine clinical data to be collected and maintained in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as part of the historical database maintained by the department.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Myelodysplastic Syndrome

Interventions

DRUG

Allopurinol

Day -8 (prior to transplant): Per institutional guidelines

DRUG

Keppra

Day -8 (prior to transplant): Per institutional guidelines

DRUG

Busulfan

Days -7 through -4 (prior to transplant): given intravenously (IV) infusion over 2 hours every 6 hours following dose, administration and pharmacokinetic monitoring per University of Minnesota institutional guidelines.

DRUG

Cyclophosphamide

Days -3 and -2 (prior to transplantation): given as a 2 hour intravenous infusion with a high volume fluid flush and mesna per institutional guidelines. Dosing is based on actual body weight.

DRUG

Tacrolimus

All patients (regardless of allograft source) will receive tacrolimus therapy beginning on day -3. Dosing will be monitored and altered as clinically appropriate per institutional pharmacy guidelines. Dose adjustments will be made on the basis of toxicity and/or low tacrolimus levels. Taper at day +100 for matched sibling donor (MSD) recipients, and day +180 for non-MSD recipients. Taper to zero by 10% weekly dose reduction over approximately 10 weeks.

DRUG

Mycophenolate mofetil

Day -3 (prior to transplant): Recipients of umbilical cord blood will given a dose of 3 gm/day every 8 or 12 hours (\> or = 40 kg) or 15 mg/kg 3 times per day (\< 40 kg) for up to 30 days unless no engraftment.

BIOLOGICAL

Allogeneic hematopoietic stem cell transplant

Day 0 (or Day+1/+2 to accommodate weekdays): Infusion of cells from related or unrelated donor bone marrow or single or double unrelated donor umbilical cord blood.

BIOLOGICAL

Filgrastim

Beginning Day +1: Intravenously (IV) 5 mcg/kg once daily and continuing until the absolute neutrophil count is \>2500 x 10\^9/L or per institutional guidelines.

BIOLOGICAL

antithymocyte globulin

Administered per institutional guidelines for recipients of umbilical cord blood transplant.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• Margaret L. MacMillan, M.D. · Masonic Cancer Center, University of Minnesota

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

44 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2020-02-10

Completion

2020-02-10

Countries

• United States

Study Locations