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Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT00943592
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : February 27, 2014
Last Update Posted : February 27, 2014
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.

Condition or disease Intervention/treatment Phase
Advanced Hematologic Malignancies Leukemia Preleukemia Drug: Clofarabine Drug: Melphalan Drug: Campath Procedure: Stem Cell Transplant Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Study Start Date : March 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : November 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Drug: Clofarabine
Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels).

Drug: Melphalan
Doses ranging from 100 to 140 mg/m2

Drug: Campath
20mg/d x5

Procedure: Stem Cell Transplant
Infusion of donor, bone marrow and auto.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation [ Time Frame: Day 7 until Day 30 ]
    Toxicity was scored according to NCI/CTC version 3

  2. Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation [ Time Frame: Day 7 until Day 30 ]
    Toxicity was scored according to NCI/CTC version 3

  3. Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation [ Time Frame: Day 7 until Day 30 ]
    Toxicity was scored according to NCI/CTC version 3

  4. Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation [ Time Frame: Day 7 until Day 30 ]
    Toxicity was scored according to NCI/CTC version 3


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 1 year ]
  2. Progression-free Survival (PFS) [ Time Frame: 1 year ]
    Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.

  3. Treatment-related Mortality (TRM) [ Time Frame: 1 year ]
  4. Relapse Rate [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed or refractory acute myelogenous or lymphoid leukemia
  • Chronic myelogenous leukemia in accelerated phase or blast-crisis
  • Chronic myelogenous leukemia in second or subsequent chronic phase
  • Recurrent or refractory malignant lymphoma or Hodgkin's disease
  • Multiple myeloma at high risk for disease recurrence
  • Chronic lymphocytic leukemia, relapsed or with poor prognostic features
  • Other Myeloproliferative disorder (polycythemia vera, essential thrombocythemia, myelofibrosis) with poor prognostic features
  • Myelodysplastic syndromes (including PNH) with > 5% blasts
  • Zubroid performance status < 2 (See Appendix B)
  • Life expectancy is not severely limited by concomitant illness
  • Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
  • Calculated Creatinine Clearance > 50 ml/min
  • Serum bilirubin 2.0 mg/dl, SGPT < 3x upper limit of normal
  • No evidence of chronic active hepatitis or cirrhosis
  • HIV-negative
  • Patient is not pregnant
  • Patient or guardian able to sign informed consent

Exclusion Criteria:

  • Clinical progression
Contacts and Locations
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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): NCT00943592


Locations
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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Andrew Artz, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00943592    
Obsolete Identifiers: NCT00572546
Other Study ID Numbers: 14341B
First Posted: July 22, 2009    Key Record Dates
Results First Posted: February 27, 2014
Last Update Posted: February 27, 2014
Last Verified: January 2014
Keywords provided by University of Chicago:
Melphalan
Alemtuzumab
Clofarabine
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Preleukemia
Neoplasms by Site
Hematologic Diseases
Precancerous Conditions
Melphalan
Alemtuzumab
Clofarabine
Antineoplastic Agents, Alkylating
 Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antimetabolites, Antineoplastic
Antimetabolites