Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT00990249|
Recruitment Status : Completed
First Posted : October 6, 2009
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Allogeneic Haematopoietic Stem Cell Transplantation Acute Lymphoblastic Leukemia||Drug: Busulfan Drug: Clofarabine Drug: Thymoglobulin Procedure: Stem Cell Transplant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Acute Lymphoblastic Leukemia or Lymphoma, or Biphenotypic Leukemia|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Busulfan + Clofarabine + Stem Cell Transplant
Busulfan test dose 32 mg/m^2 by vein over 45 minutes on Day -8; following doses on Days -6 to -3 derived from pharmacokinetic (PK) testing done up to 11 times over 11 hours after test dose.
Clofarabine 40 mg/m^2 by vein over 1 hour daily Day -6 through Day -3. Thymoglobulin 0.5 mg/kg on Day -3, 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1; only patients with HLA nonidentical or unrelated donors.
Stem cell infusion on Day 0.
Test Dose 32 mg/m^2 by vein over 45 minutes on Day -8; following doses on Days -6 to -3 derived from pharmacokinetic (PK) testing done up to 11 times over 11 hours after test dose.
40 mg/m^2 by vein over 1 hour daily Day -6 through Day -3
0.5 mg/kg on Day -3, 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1; only patients with HLA nonidentical or unrelated donors
Procedure: Stem Cell Transplant
Stem cell infusion on Day 0.
- Treatment-Related Mortality (TRM) Defined as Non Relapse Mortality (NRM) [ Time Frame: 100 Days ]NRM was defined as death from any cause other than disease progression or relapse and reported as percentage of participant deaths. Treatment related deaths after transplant are defined either by deaths which could not be attributed to disease relapse or progression or by deaths without previous relapse or progression. For TRM at day 100, Bayesian method of Thall, Simon, and Estey used to perform interim monitoring.
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): NCT00990249
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Partow Kebriaei, MD||M.D. Anderson Cancer Center|