Alemtuzumab + Rituximab Consolidation in CLL
This study has been terminated.
(Lack of accrual.)
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Genzyme
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
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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:
|
|
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:
|
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
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
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 Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Alemtuzumab |
Rituximab Campath 1G Antibodies, Neoplasm Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013