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

NCT ID: NCT00943592

Last Updated: 2014-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2013-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

Clofarabine

Intervention Type: 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

Intervention Type: DRUG

Doses ranging from 100 to 140 mg/m2

Campath

Intervention Type: DRUG

20mg/d x5

Stem Cell Transplant

Intervention Type: PROCEDURE

Infusion of donor, bone marrow and auto.

Interventions

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).

Intervention Type: DRUG

Melphalan

Doses ranging from 100 to 140 mg/m2

Intervention Type: DRUG

Campath

20mg/d x5

Intervention Type: DRUG

Stem Cell Transplant

Infusion of donor, bone marrow and auto.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Artz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

14341B

Identifier Type: -

Identifier Source: org_study_id

NCT00572546

Identifier Type: -

Identifier Source: nct_alias