Study Stopped
Replaced by a different study
Stem Cell Transplantation for Hematological Malignancies
Busulfan, Cyclophosphamide, and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies
3 other identifiers
interventional
11
1 country
1
Brief Summary
This protocol using busulfan, cyclophosphamide and melphalan has been designed as conditioning therapy for patients receiving stem cell transplantation for acute leukemia or myelodysplastic syndrome (MDS). The hypothesis is that this new regimen will be well tolerated and will cure the patient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2000
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2000
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
February 13, 2013
CompletedDecember 5, 2017
December 1, 2017
11.7 years
September 12, 2005
January 11, 2013
December 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Probability of Long-term Disease-free Survival (DFS)
Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
1 year
Secondary Outcomes (5)
Probability of Engraftment
1 year
Incidence of Acute Graft-versus-host Disease (GVHD)
100 days post-transplant
Incidence Chronic Graft-versus-host Disease (GVHD)
1 year
Incidence of Regimen-related Toxicity 100 Days Post Transplant
100 days post-transplant
Incidence of Relapse
1 year
Study Arms (1)
Treatment Arm
EXPERIMENTALPatients treated with therapy plan consisting of Busulfan every 6 hours on days -7 through -4, Cyclophosphamide 60 mg/kg/day IV x 2 days, Melphalan 140 mg/m on day -1, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation on day 0.
Interventions
Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
Prior to transplantation, subjects will receive BUSULFAN via the central venous line, four times a day for four days (days -7 through -4).
Prior to stem cell transplantation, subjects will receive CYCLOPHOSPHAMIDE via the central venous line once a day for two days on days -3 and -2.
MELPHALAN will be given via the central venous line for one day, on day -1, prior to stem cell transplantation.
G-CSF is to be given daily IV beginning on day +1 until ANC 2.5 x 109/L.
ATG will be administered to umbilical cord blood recipients.
Eligibility Criteria
You may qualify if:
- Patients must have a diagnosis of acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and currently be in complete remission.
- Patients must be either:
- \- \<18 years of age who are at least 6 months after initial hematopoietic cell transplant (HCT),
- \- 19-35 years of age and at least 18 months after initial HCT, or
- \- \<35 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy
- Adequate major organ function including:
- \- Cardiac: ejection fraction \> or = 45%
- \- Renal: creatinine clearance \> or = 40 mL/min
- \- Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
- \- Karnofsky performance status \> or = 70% or Lansky score \> or = 50%
- Women of child bearing age must be using adequate birth control and have a negative pregnancy test.
- Written informed consent.
You may not qualify if:
- Eligible for TBI containing preparative regimen.
- Active uncontrolled infection within one week of HCT.
- Pregnant or lactating females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Margaret MacMillan, M.D.
- Organization
- University of Minnesota Masonic Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret MacMillan, MD
Masonic Cancer Center, University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
June 7, 2000
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
December 5, 2017
Results First Posted
February 13, 2013
Record last verified: 2017-12