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Completed

NCT Number: NCT00943592

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.

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Key information

Conditions

Advanced Hematologic Malignancies Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type Precancerous Conditions Preleukemia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clofarabine

Drug

Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels).

melphalan

Drug

Doses ranging from 100 to 140 mg/m2

Campath

Drug

20mg/d x5

Stem Cell Transplant

Procedure

Infusion of donor, bone marrow and auto.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2013
First posted
Jul 22, 2009
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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