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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
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to test the safety of giving clofarabine in combination with busulfan, followed by an allogeneic (from a donor) stem cell transplant, in patients with advanced leukemia or lymphoma.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.

Drug: 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.
Other Names:
  • Busulfex
  • Myleran

Drug: Clofarabine
40 mg/m^2 by vein over 1 hour daily Day -6 through Day -3
Other Names:
  • Clolar
  • Clofarex

Drug: 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
Other Names:
  • Anti-thymocyte globulin
  • ATG

Procedure: Stem Cell Transplant
Stem cell infusion on Day 0.
Other Names:
  • Allogeneic hematopoietic cell transplant
  • HCT




Primary Outcome Measures :
  1. Treatment-Related Mortality (TRM) [ Time Frame: Baseline and at day 100 of treatment ]
    For TRM at day 100, Bayesian method of Thall, Simon, and Estey used to perform interim monitoring. Rates of 100-day progression-free survival (PFS) and TRM estimated separately by cohort and provided with 95% credible intervals.



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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with biopsy-proven acute lymphoblastic leukemia, acute lymphoblastic lymphoma, or acute biphenotypic leukemia in remission or relapse.
  2. Adequate renal function, as defined by estimated serum creatinine clearance >60 ml/min.
  3. Bilirubin equal or less than 1.5 (unless Gilbert's Syndrome), serum glutamate pyruvate transaminase (SGPT) <3 X upper limit of normal and alkaline phosphatase <2 X upper limit of normal.
  4. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) at least 45% of expected corrected for hemoglobin. Children unable to perform pulmonary functions must have an oxygen saturation greater than 92% at room air.
  5. Adequate cardiac function with left ventricular ejection fraction at least 45% on appropriate medical therapy. No uncontrolled arrhythmias or symptomatic cardiac disease.
  6. Zubrod performance status <2 or Lansky/Karnofsky PS equal or greater to 70%.
  7. Patients must have a related, genotypically HLA identical donor, or they must have a unrelated donor who is 8/8 HLA match by high resolution typing.
  8. Patient or patient's legal representative, parent(s) or guardian should provide written informed consent. Assent of a minor if participant's age is at least seven and less than eighteen years.
  9. Negative Beta Human Chorionic Gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization.

Exclusion Criteria:

  1. Patients with unresolved grade >2 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI.
  2. Patients with active central nervous system (CNS) disease.
  3. Evidence of acute or chronic active hepatitis or cirrhosis.
  4. Uncontrolled infection, including HIV, HTLV-1, hepatitis B or hepatitis C viremia.
  5. Patients greater than 65 years-old.
  6. Prior autologous or allogeneic hematopoietic stem cell transplant.

Information from the National Library of Medicine

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


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Partow Kebriaei, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00990249     History of Changes
Other Study ID Numbers: 2009-0209
NCI-2012-01270 ( Registry Identifier: NCI CTRP )
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by M.D. Anderson Cancer Center:
Acute Lymphoblastic Leukemia
ALL
Acute lymphoblastic lymphoma
acute biphenotypic leukemia
Allogeneic hematopoietic cell transplantation
HCT
Stem Cell Transplant
Treatment-related mortality
Tyrosine kinase inhibitors
TKI
Busulfan
Busulfex
Myleran
Clofarabine
Clolar
Clofarex
Gleevec
Imatinib Mesylate

Additional relevant MeSH terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Busulfan
Thymoglobulin
Antilymphocyte Serum
Clofarabine
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites