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Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy

NCT00800943 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2008-12-03

No results posted yet for this study

Summary

To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in patients who have achieved a complete remission (CR) or b) convert partial remission to complete remission.

To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry.

To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.

Conditions

  • B-Cell Chronic Lymphocytic Leukemia

Interventions

BIOLOGICAL

Alemtuzumab (Campath-1H)

Campath is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg,10mg,and 30mg, administered subcutaneously (SC) (if tolerated). When escalation to 30 mg dose is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 8 weeks

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Chronic Lymphocytic Leukemia Research Consortium

    lead NETWORK

Principal Investigators

  • Thomas Kipps, MD, PhD · Director, Chronic Lymphocytic Leukemia Research Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800943 on ClinicalTrials.gov