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

NCT00943592 | Completed Phase 1 Results DMC

• 1 other identifier: 14341B
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Hematologic Malignancies; Leukemia; Preleukemia

Keywords

Melphalan; Alemtuzumab; Clofarabine

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation

  Toxicity was scored according to NCI/CTC version 3

  Day 7 until Day 30

• Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation

  Toxicity was scored according to NCI/CTC version 3

  Day 7 until Day 30

• Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation

  Toxicity was scored according to NCI/CTC version 3

  Day 7 until Day 30

• Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation

  Toxicity was scored according to NCI/CTC version 3

  Day 7 until Day 30

Secondary Outcomes (4)

• Overall Survival (OS)

  1 year

• Progression-free Survival (PFS)

  1 year

• Treatment-related Mortality (TRM)

  1 year

• Relapse Rate

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Clofarabine; Drug: Melphalan; Drug: Campath; Procedure: Stem Cell Transplant

Interventions

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).

Treatment

Melphalan DRUG

Doses ranging from 100 to 140 mg/m2

Treatment

Campath DRUG

20mg/d x5

Treatment

Stem Cell Transplant PROCEDURE

Infusion of donor, bone marrow and auto.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Clinical progression

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Leukemia; Preleukemia

Interventions

Clofarabine; Melphalan; Alemtuzumab; Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Andrew Artz
• Organization: University of Chicago

aartz@medicine.bsd.uchicago.edu

773-834-8980

Study Officials

• Andrew Artz, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 22, 2009
• Study Start: March 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2013
• Last Updated: February 27, 2014
• Results First Posted: February 27, 2014

Record last verified: 2014-01

Locations

US (1)