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Allogeneic Stem Cell Transplant With Clofarabine, Ara-C and TBI for AML and ALL
This study is currently recruiting participants.
Verified by Columbia University, April 2008
Sponsors and Collaborators: Columbia University
Genzyme
Information provided by: Columbia University
ClinicalTrials.gov Identifier: NCT00529360
  Purpose

Hypothesis: Myeloablative conditioning using a dose escalation of clofarabine in combination with cytarabine (ARA-C) and total body irradiation (TBI) will lead to improved survival for previously untransplanted children and adolescents with acute lymphoblastic leukemia (ALL) and acute non-lymphoblastic leukemia (ANLL)followed by allogeneic stem cell transplantation (AlloSCT).


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Drug: Clofarabine
Phase I
Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Cytarabine Cytarabine hydrochloride Clofarabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Clofarabine in Combination With Cytarabine and Total Body Irradiation Followed by Allogeneic Stem Cell Transplantation in Children With Acute Lymphoblastic Leukemia and Acute Non-Lymphoblastic Leukemia

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) and/or the safe, tolerated dose of clofarabine in combination with ARA-C and TBI followed by AlloSCT in children with ALL and ANLL. [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • To define the toxicity and safety of the conditioning regimen of clofarabine, ARA-C, TBI followed by AlloSCT in children with ALL and ANLL. [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • To define the pharmacokinetics of clofarabine given in combination with ARA-C and TBI followed by AlloSCT in children with ALL and ANLL. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the event-free, disease-free and overall survival of the conditioning regimen of clofarabine, ARA-C and TBI followed by AlloSCT in children with ALL and AML. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To estimate the time to hematopoietic reconstitution, stratified by cell source, following clofarabine, ARA-C and TBI followed by AlloSCT in children with ALL and AML. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • To measure the changes in minimal residual disease with ALL and AML following clofarabine, ARA-C and TBI followed by AlloSCT [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Part A: Experimental
Part A will be the dose escalation phase to determine the MTD and/or safe/tolerated dose of clofarabine.
Drug: Clofarabine
Dose escalation of clofarabine on Days -9, -8, -7, -6, -5: 1 - 30 mg/m2; 2 - 40 mg/m2; 2 - 46 mg/m2; 3 - 52 mg/m2; 4 - 60 mg/m2
Part B: Experimental
Part B will accrue patients to further define the event free, disease free and overall survival at the MTD or safe/tolerated dose of clofarabine.
Drug: Clofarabine
Use dose of clofarabine established in Part A to further define event free, disease free and overall survival.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: Patients must be <30 years of age.
  • Disease Status: ALL in relapse, induction failure, CR3, or CR3P (Part A ONLY); AML in relapse, induction failure, CR3, or CR3P (Part A ONLY); ALL in CR3 or CR3P (Part A and Part B); AML in CR3 or CR3P (Part A and BONLY); CR3/CR3P must be documented by bone marrow and CNS assessment within 14 days of initiation of the pre-transplant conditioning regimen.
  • Creatinine clearance >40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range or serum creatinine based on age
  • Adequate liver function defined as: Total bilirubin <2.5 mg/dl l, or SGOT (AST) or SGPT (ALT) <5 x upper limit of normal
  • Adequate cardiac function defined as: Shortening fraction >27% by echocardiogram, or Ejection fraction of >50% by radionuclide angiogram or echocardiogram.
  • Adequate pulmonary function defined as: Corrected DLCO >60% by pulmonary function test; For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air.
  • Performance Status: For patients age 1-16 years, Lansky score of >60; For patients > 16 years, Karnofsky score of >60.
  • Patients must have received a minimum of one round of re-induction and one round of consolidation chemotherapy after relapse #2

Exclusion Criteria:

  • Patients with prior myeloablative allogeneic stem cell transplantation and /or TBI.
  • Females who are pregnant (positive HCG) or lactating.
  • Karnofsky <60% or Lansky <60% if less than 16 years of age
  • Age >30 years of age
  • Any patient with uncontrolled infection prior to study entry
  • Patients with evidence of active disease.
  • Patients with Down syndrome are excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529360

Contacts
Contact: Mitchell S Cairo, MD 212-305-8316 mc1310@columbia.edu
Contact: Lauren Harrison, RN 978-993-4372 la313@columbia.edu

Locations
United States, New York
Columbia Presbyterian Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Mitchell S Cairo, MD            
Sub-Investigator: Mary Brigid Bradley, MD            
Sub-Investigator: Prakash Satwani, MD            
Sub-Investigator: Diane George, MD            
Sub-Investigator: Monica Bhatia, MD            
Sponsors and Collaborators
Columbia University
Genzyme
Investigators
Principal Investigator: Mitchell S Cairo, MD Columbia University
  More Information

Responsible Party: Columbia University ( Mitchell S. Cairo, MD/ Principal Investigator )
Study ID Numbers: CHNY-06-532, AAAC0918
Study First Received: September 11, 2007
Last Updated: April 29, 2008
ClinicalTrials.gov Identifier: NCT00529360  
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Acute Leukemia
Allogeneic Stem Cell Transplant
Clofarabine
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia

Study placed in the following topic categories:
Clofarabine
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Lymphatic Diseases
Lymphoproliferative Disorders
Lymphoma
Acute myelocytic leukemia
Cytarabine

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009