Alemtuzumab + Rituximab Consolidation in CLL

NCT00771602 | Terminated Phase 2 Results

• 1 other identifier: 2006-0767
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia; Leukemia

Keywords

Chronic Lymphocytic Leukemia; Leukemia; CLL; PLL; SLL; Rituximab; Rituxan; Alemtuzumab; Campath

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Molecular Remissions at 52 Weeks

  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.

  52 weeks

Secondary Outcomes (2)

• Progression-free Survival

  52 weeks or until disease progression

• 52 Week Toxicity Rate

  52 weeks

Study Arms (3)

Rituximab

EXPERIMENTAL

Group 1: 375 mg/m\^2 IV Rituximab Alone

Drug: Rituximab

Alemtuzumab

EXPERIMENTAL

Group 2: 30 mg SQ Alemtuzumab Alone

Drug: Alemtuzumab

Rituximab + Alemtuzumab

EXPERIMENTAL

Group 3: 375 mg/m\^2 Rituximab + 30 mg SQ Alemtuzumab

Drug: Rituximab; Drug: Alemtuzumab

Interventions

Rituximab DRUG

375 mg/m\^2 by standard IV (intravenous) infusion on days 1, 8, 15, and 22 of weeks 1-4.

Also known as: Rituxan®

Rituximab; Rituximab + Alemtuzumab

Alemtuzumab DRUG

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).

Also known as: Campath®, Campath-1H

Alemtuzumab; Rituximab + Alemtuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson's Website

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

Rituximab; Alemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Results Point of Contact

• Title: Stefan Faderl, MD / Professor
• Organization: UT MD Anderson Cancer Center

713-745-4613

Study Officials

• Stefan Faderl, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 23, 2015
• Results First Posted: April 29, 2011

Record last verified: 2015-05

Locations

US (1)