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
  Purpose

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 Intervention Phase
Advanced Hematologic Malignancies
Leukemia
Preleukemia
Drug: Clofarabine
Drug: Melphalan
Drug: Campath
Procedure: Stem Cell Transplant
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 82
Study Start Date: March 2006
Study Completion Date: November 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943592

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Andrew Artz, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00943592     History of Changes
Obsolete Identifiers: NCT00572546
Other Study ID Numbers: 14341B
Study First Received: July 20, 2009
Results First Received: September 17, 2013
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Melphalan
Alemtuzumab
Clofarabine

Additional relevant MeSH terms:
Neoplasms
Leukemia
Preleukemia
Myelodysplastic Syndromes
Hematologic Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions
Hematologic Diseases
Bone Marrow Diseases
Neoplasms by Site
Melphalan
Clofarabine
Alemtuzumab
Campath 1G
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014