Busulfan and Cyclophosphamide Followed By ALLO BMT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01685411|
Recruitment Status : Recruiting
First Posted : September 14, 2012
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Myelodysplastic Syndrome||Drug: Allopurinol Drug: Keppra Drug: Busulfan Drug: Cyclophosphamide Drug: Tacrolimus Drug: Mycophenolate mofetil Biological: Allogeneic hematopoietic stem cell transplant Biological: Filgrastim Biological: antithymocyte globulin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||September 2025|
|Estimated Study Completion Date :||September 2025|
Experimental: Allogeneic Hematopoietic Stem Cell Transplant
Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
Day -8 (prior to transplant): Per institutional guidelines
Day -8 (prior to transplant): Per institutional guidelines
Other Name: Levetiracetam
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.
Other Name: Myleran
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.
Other Name: Cytoxan
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.
Other Name: MMF
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.
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.
Other Name: ATG
- Disease Free Survival [ Time Frame: 2 Years ]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.
- Disease Free Survival [ Time Frame: 5 Years ]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.
- Disease Free Survival [ Time Frame: 10 Years ]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.
- Days to Neutrophil Engraftment [ Time Frame: By Day 42 ]Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm^3 (0.5 x 10^9/L) or greater.
- Incidence of Acute Graft-Versus-Host Disease [ Time Frame: Day 100 ]Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
- Incidence of Chronic Graft-Versus-Host Disease [ Time Frame: 6 Months and 1 Year ]Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
- Incidence of Treatment-Related Toxicity [ Time Frame: 6 Months and 1 Year ]In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
- Incidence of Relapse [ Time Frame: 1 Year and 2 Years ]The return of disease after its apparent recovery/cessation.
- Incidence of Engraftment Failure [ Time Frame: Day 42 ]Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
- Overall Survival [ Time Frame: 2 Years, 5 Years and 10 Years ]Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685411
|Contact: Margaret L. MacMillan, M.D.||email@example.com|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Margaret L. MacMillan, M.D. 612-626-2778 firstname.lastname@example.org|
|Principal Investigator: Margaret L. MacMillan, M.D.|
|Principal Investigator:||Margaret L. MacMillan, M.D.||Masonic Cancer Center, University of Minnesota|