Alemtuzumab + Rituximab Consolidation in CLL

This study has been terminated.
(Lack of accrual.)
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00771602
First received: October 10, 2008
Last updated: April 4, 2011
Last verified: April 2011
  Purpose

The goal of this clinical research study is to find out how well Campath (alemtuzumab), Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia (CLL) that is left after chemotherapy. The safety of these drugs will also be studied.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Leukemia
Drug: Rituximab
Drug: Alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Rituximab vs Alemtuzumab vs Alemtuzumab + Rituximab as Consolidation Therapy for Patients With Chronic Lymphocytic Leukemia (CLL) With Evidence of Residual Disease Following Prior Chemo(Immuno)Therapy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients With Molecular Remissions at 52 Weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: 52 weeks or until disease progression ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) is measured from date of trial entry until documented progression of disease or death from any cause.

  • 52 Week Toxicity Rate [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    The definition of toxicities include any >/= grade 3 non-hematologic toxicity, >/= grade 3 infection, and any symptomatic (i.e. febrile) documented CMV (cytomegalovirus) reactivation, according to NCI-WG definitions.


Enrollment: 1
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab
Group 1: 375 mg/m^2 IV Rituximab Alone
Drug: Rituximab
375 mg/m^2 by standard IV (intravenous) infusion on days 1, 8, 15, and 22 of weeks 1-4.
Other Name: Rituxan®
Experimental: Alemtuzumab
Group 2: 30 mg SQ Alemtuzumab Alone
Drug: Alemtuzumab
Dose escalation of 3, 10 and 30 mg subcutaneously (SQ) during week 1, followed by dose of 30 mg subcutaneously three times weekly (e.g. Monday-Wednesday - Friday) starting on week 2 for a total of 12 weeks (2-13).
Other Names:
  • Campath®
  • Campath-1H
Experimental: Rituximab + Alemtuzumab
Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
Drug: Rituximab
375 mg/m^2 by standard IV (intravenous) infusion on days 1, 8, 15, and 22 of weeks 1-4.
Other Name: Rituxan®
Drug: Alemtuzumab
Dose escalation of 3, 10 and 30 mg subcutaneously (SQ) during week 1, followed by dose of 30 mg subcutaneously three times weekly (e.g. Monday-Wednesday - Friday) starting on week 2 for a total of 12 weeks (2-13).
Other Names:
  • Campath®
  • Campath-1H

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with CLL, CLL/prolymphocytic leukemia (PLL), or Small Lymphocytic Lymphoma (SLL) who have achieved an National Cancer Institute-Working Group (NCI-WG) nodular partial (nPR) or complete response (CR) with documentation of residual disease by MRD flow cytometry following chemotherapy or chemoimmunotherapy.
  • Patients with CLL, CLL/PLL, or SLL who have achieved an NCI-WG partial response (PR) following prior chemotherapy or chemoimmunotherapy.
  • Age >/=18 years.
  • ECOG performance status </=2.
  • Serum creatinine </= 2 mg/dL; serum total bilirubin </= 2 mg/dL; serum AST or ALT <4 x ULN.
  • Signed informed consent.
  • Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients of childbearing potential (non-childbearing is defined as >/= 1 year post-menopausal or surgically sterilized) need a negative serum or urine pregnancy test within 14 days of study enrollment.

Exclusion Criteria:

  • Past history of anaphylaxis following exposure to rat or mouse derived complementarity determining region (CDR)-grafted humanized monoclonal antibodies.
  • Hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted.
  • Active Hepatitis B (at least one of the following markers positive: HBsAg, HBeAg, IgM anti-HBc, HBV DNA).
  • Previous treatment with alemtuzumab plus rituximab in combination.
  • Pregnant or nursing women.
  • History of HIV infection.
  • Active uncontrolled infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  • Less than 6 months from the completion of prior chemotherapy or chemoimmunotherapy. Completion of prior chemoimmunotherapy is defined as the last day of therapy of the respective treatment regimen.
  • Symptomatic CNS disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771602

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Investigators
Principal Investigator: stefan Faderl, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Stefan Faderl M.D./ Associate Professor, The University of Texas M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00771602     History of Changes
Other Study ID Numbers: 2006-0767
Study First Received: October 10, 2008
Results First Received: April 4, 2011
Last Updated: April 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
Leukemia
CLL
PLL
SLL
Rituximab
Rituxan
Alemtuzumab
Campath

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014