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Trial record 96 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Allogeneic Stem Cell Transplant With Clofarabine, Ara-C and TBI for AML and ALL

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ClinicalTrials.gov Identifier: NCT00529360
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : March 24, 2016
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Mitchell Cairo, New York Medical College

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia Drug: Clofarabine Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2007
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016


Arm Intervention/treatment
Experimental: Part A
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
Other Name: Clolar®

Experimental: Part B
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.
Other Name: Clolar®




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): NCT00529360


Locations
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United States, New York
New York Medical College
Vallhala, New York, United States, 10595
Sponsors and Collaborators
New York Medical College
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Mitchell S Cairo New York Medical College

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Responsible Party: Mitchell Cairo, Principal Investigator, New York Medical College
ClinicalTrials.gov Identifier: NCT00529360     History of Changes
Other Study ID Numbers: L 9471
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016
Keywords provided by Mitchell Cairo, New York Medical College:
Acute Leukemia
Allogeneic Stem Cell Transplant
Clofarabine
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Clofarabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents