NCT01685411

Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies

Terminated NA Results posted Last updated 17 March 2021

What this trial tests

NA trial testing Allopurinol in Acute Lymphoblastic Leukemia in 5 participants. Terminated before completion.

Timeline

1 January 2013

Primary endpoint
10 February 2020

10 February 2020

Quick facts

Lead sponsor	Masonic Cancer Center, University of Minnesota
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 January 2013
Primary completion	10 February 2020
Estimated completion	10 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Allopurinol
• Keppra — full drug profile →
• Busulfan — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Tacrolimus
• Mycophenolate mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
• Allogeneic hematopoietic stem cell transplant
• Filgrastim
• antithymocyte globulin

Conditions studied

• Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
• Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →

Sponsor

Masonic Cancer Center, University of Minnesota

Who can join

Under 44, any sex, with Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Counts of Participants With 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. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogeneti
• Count of Participants With 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. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics o
• Count of Participants With Disease Free Survival
  Time frame: 7 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. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics o

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trial watch: Chemotherapy with immunogenic cell death inducers.
   Vacchelli E, Senovilla L, Eggermont A, Fridman WH, et al · · 2013 · cited 83× · PMID 23687621 · DOI 10.4161/onci.23510