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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00943592
First received: July 20, 2009
Last updated: January 9, 2014
Last verified: January 2014

July 20, 2009
January 9, 2014
March 2006
April 2011   (final data collection date for primary outcome measure)
  • Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation [ Time Frame: Day 7 until Day 30 ] [ Designated as safety issue: Yes ]
    Toxicity was scored according to NCI/CTC version 3
  • Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation [ Time Frame: Day 7 until Day 30 ] [ Designated as safety issue: Yes ]
    Toxicity was scored according to NCI/CTC version 3
  • Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation [ Time Frame: Day 7 until Day 30 ] [ Designated as safety issue: Yes ]
    Toxicity was scored according to NCI/CTC version 3
  • Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation [ Time Frame: Day 7 until Day 30 ] [ Designated as safety issue: Yes ]
    Toxicity was scored according to NCI/CTC version 3
Toxicity of conditioning regimen prior to stem cell transplantation. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00943592 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.
  • Treatment-related Mortality (TRM) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Relapse Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To explore the correlation between the pharmacologic determinants of clofarabine metabolism and cellular uptake and study outcomes. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Hematologic Malignancies
  • Leukemia
  • Preleukemia
  • 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.
Experimental: Treatment
Interventions:
  • Drug: Clofarabine
  • Drug: Melphalan
  • Drug: Campath
  • Procedure: Stem Cell Transplant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
November 2013
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00943592
14341B
Yes
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Andrew Artz, MD University of Chicago
University of Chicago
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP