Busulfan and Cyclophosphamide Followed By ALLO BMT

NCT01685411 | Terminated Results DMC

• 2 other identifiers: 2011OC139MT2011-20C
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Counts of Participants With Disease Free Survival

  The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

  2 Years

• Count of Participants With Disease Free Survival

  The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

  5 Years

• Count of Participants With Disease Free Survival

  The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

  7 Years

Secondary Outcomes (12)

• Count of Participants Who Achieved Neutrophil Engraftment

  By Day 42

• Percentage of Participants With Acute Graft-Versus-Host Disease by Grade

  Day 100

• Percentage of Participants With Chronic Graft-Versus-Host Disease

  6 Months

• Percentage of Participants With Chronic Graft-Versus-Host Disease

  1 Year

• Percentage of Participants With Treatment-Related Toxicity

  6 Months

Study Arms (1)

Allogeneic Hematopoietic Stem Cell Transplant

EXPERIMENTAL

Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.

Drug: Allopurinol; Drug: Keppra; Drug: Busulfan; Drug: Cyclophosphamide; Drug: Tacrolimus; Drug: Mycophenolate mofetil; Biological: Allogeneic hematopoietic stem cell transplant; Biological: Filgrastim; Biological: antithymocyte globulin

Interventions

Allopurinol DRUG

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

Also known as: Lopurin, Zyloprim

Allogeneic Hematopoietic Stem Cell Transplant

Keppra DRUG

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

Also known as: Levetiracetam

Allogeneic Hematopoietic Stem Cell Transplant

Busulfan DRUG

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.

Also known as: Myleran

Allogeneic Hematopoietic Stem Cell Transplant

Cyclophosphamide DRUG

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.

Also known as: Cytoxan

Allogeneic Hematopoietic Stem Cell Transplant

Tacrolimus DRUG

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.

Allogeneic Hematopoietic Stem Cell Transplant

Mycophenolate mofetil DRUG

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.

Also known as: MMF

Allogeneic Hematopoietic Stem Cell Transplant

Allogeneic hematopoietic stem cell transplant BIOLOGICAL

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.

Allogeneic Hematopoietic Stem Cell Transplant

Filgrastim BIOLOGICAL

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.

Also known as: G-CSF, Granulocyte-colony stimulating factor

Allogeneic Hematopoietic Stem Cell Transplant

antithymocyte globulin BIOLOGICAL

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

Also known as: ATG

Allogeneic Hematopoietic Stem Cell Transplant

Eligibility Criteria

• Age: Up to 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and current in complete remission meeting one of the following:
• \<45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (HSCT)
• \<45 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy
• Karnofsky performance status \>70% or if \<16 years of age, a Lansky play score \>50
• Adequate major organ function including:
• cardiac: left ventricular ejection fraction \>45% by echocardiogram (ECHO/MUGA)
• renal: creatinine clearance \>40 mL/min/1.73m\^2
• hepatic: no clinical evidence of hepatic failure (e.g., coagulopathy, ascites)
• An acceptable source of stem cells according to current University of Minnesota Bone Marrow Transplant program guidelines. Acceptable stem cell sources include:
• HLA-matched related or unrelated donor bone marrow (6/6 or 5/6 antigen match)
• HLA-matched related or unrelated donor peripheral blood stem cells
• related or single or double unrelated donor umbilical cord blood (6/6, 5/6 or 4/6 match)
• Women of childbearing age must have a negative pregnancy test and all sexually active participants must agree to use effective contraception during study treatment
• Written consent (adult or parent/guardian)

You may not qualify if:

• eligible for TBI containing preparative regimen
• active uncontrolled infection within one week of study enrollment
• pregnant or lactating female

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Allopurinol; Levetiracetam; Busulfan; Cyclophosphamide; Tacrolimus; Mycophenolic Acid; Filgrastim; Granulocyte Colony-Stimulating Factor; Antilymphocyte Serum

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Macrolides; Lactones; Caproates; Fatty Acids; Lipids; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Margaret L. MacMillan, M.D.
• Organization: Masonic Cancer Center, University of Minnesota

macmi002@umn.edu

612-626-2778

Study Officials

• Margaret L. MacMillan, M.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 14, 2012
• Study Start: January 1, 2013
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-03

Locations

US (1)