Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders

This study has been completed.

Study NCT00071396 Information provided by M.D. Anderson Cancer Center

First Received on October 21, 2003. Last Updated on April 13, 2011 History of Changes

Results First Received: September 25, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Chronic Lymphocytic Leukemia
Interventions:	Drug: Campath-1H Drug: Rituximab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period 10/21/02 - 3/27/09; all patients were registered at the University of Texas MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 48 patients enrolled, 41 patients were evaluable for response (2 patients withdrew before starting treatment and 2 were ineligible).

Reporting Groups

	Description
Campath-1H + Rituximab	Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22.

Description

Campath-1H + Rituximab

Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.

Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22.

Participant Flow: Overall Study

	Campath-1H + Rituximab
STARTED	44
COMPLETED	41 ^[1]
NOT COMPLETED	3
Withdrawal by Subject	1
Physician Decision	2

[1]	Evaluable for response.

Baseline Characteristics

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Reporting Groups

	Description
Campath-1H + Rituximab	Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22.

Description

Campath-1H + Rituximab

Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.

Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22.

Baseline Measures

	Campath-1H + Rituximab
Number of Participants [units: participants]	44
Age [units: years] Median ( Full Range )	59 ( 39 to 78 )
Gender [units: participants]
Female	9
Male	35
Region of Enrollment [units: participants]
United States	44

Outcome Measures

1. Primary:

Overall Response [ Time Frame: After each 4 week course of treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Alessandra Ferrajoli, MD, BS / Assistant Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713-745-4613
e-mail: eharriso@mdanderson.org

No publications provided

Responsible Party:	Alessandra Ferrajoli, MD, BS / Assistant Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00071396 History of Changes
Other Study ID Numbers:	ID02-368
Study First Received:	October 21, 2003
Results First Received:	September 25, 2009
Last Updated:	April 13, 2011
Health Authority:	United States: Food and Drug Administration