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

Leukemia Clinical Trial

Official title:

Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943592
• Other study ID #: 14341B
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 20, 2009
• Last updated: January 9, 2014
• Start date: March 2006
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00572546

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Hematologic Malignancies
• Leukemia
• Neoplasms
• Preleukemia

Intervention

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).
• Melphalan
Doses ranging from 100 to 140 mg/m2
• Campath
20mg/d x5

Procedure:
• Stem Cell Transplant
Infusion of donor, bone marrow and auto.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Overall Survival (OS)		1 year	No
Secondary	Progression-free Survival (PFS)	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.	1 year	No
Secondary	Treatment-related Mortality (TRM)		1 year	No
Secondary	Relapse Rate		1 year	No