Lenalidomide With or Without Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Undergone Autologous or Syngeneic Stem Cell Transplant - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00833534

Purpose

RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.

Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether lenalidomide is more effective with or without rituximab in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.

PURPOSE: This phase II trial is studying how well lenalidomide works when given with or without rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplant.

Condition	Intervention	Phase
Leukemia Lymphoma	Biological: rituximab Drug: lenalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Consolidation Therapy With Lenalidomide (Revlimid®) With or Without Rituximab Followed by Maintenance Therapy With Revlimid® After Autologous/Syngeneic Transplant for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Rituximab Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy [ Designated as safety issue: No ]
Disease-free survival at 2 years after transplant [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity during consolidation and maintenance therapy as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Ability to complete planned therapy [ Designated as safety issue: No ]
Complete hematological remission, including bone marrow IgH remission status as assessed by PCR after consolidation and maintenance therapy [ Designated as safety issue: No ]
Time to disease progression [ Designated as safety issue: No ]
Relapse rates [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2009
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group I (consolidation phase): Experimental Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.	Drug: lenalidomide Given orally
Group II (consolidation phase): Experimental Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.	Biological: rituximab Given IV Drug: lenalidomide Given orally

Detailed Description:

OBJECTIVES:

Primary

To evaluate the efficacy of consolidation therapy comprising lenalidomide with or without rituximab followed by maintenance therapy comprising lenalidomide in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplantation.

OUTLINE:

Consolidation phase: Patients are assigned to 1 of 2 treatment groups.
- Group I: Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
- Group II: Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
Maintenance phase: Beginning 2 months after completion of consolidation therapy, all patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 18 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 28 days and then annually thereafter.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- Any stage disease
Prior histological documentation of CD20+ CLL or SLL
Has undergone autologous or syngeneic stem cell transplantation comprising high-dose therapy with peripheral blood stem cell rescue within the past 30-120 days
- No progressive disease after transplantation
  - Has had stable disease or some degree of response to transplantation
No history of CNS involvement

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%
Platelet count ≥ 50,000/mm³* (transfusion independent)
ANC ≥ 1,500/mm³*
Total bilirubin ≤ 2 mg/mL (unless due to Gilbert's disease)
SGOT/SGPT ≤ 2.5 times upper limit of normal
Serum creatinine ≤ 2 mg/mL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 effective methods of contraception for at least 28 days before, during, and for at least 28 days after completion of study therapy
Patients and their physician must be registered in the RevAssist® program and be willing and able to comply with the requirements of RevAssist®
LVEF ≥ 45% immediately prior to transplant
No uncontrolled congestive heart disease
No history of myocardial infarction or coronary artery disease
No peripheral neuropathy ≥ grade 3
No allergy to lenalidomide, thalidomide, allopurinol, or rituximab
No known hepatitis B, hepatitis C, or HIV seropositivity
No other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
No concurrent serious uncontrolled medical or psychiatric illness, including serious infection NOTE: *For 5 calendar days after transplant

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior CD34-selected stem cell product
No chemotherapy or biologic therapy for CLL after transplant
Prior rituximab administered before stem cell collection allowed
Prior lenalidomide administered before transplant allowed provided patient responded to lenalidomide
No concurrent sargramostim (GM-CSF)
No other concurrent anticancer therapies, including radiotherapy or thalidomide
No other concurrent investigational agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833534

Locations

United States, Washington
Fred Hutchinson Cancer Research Center	Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Leona A. Holmberg, MD, PhD 206-667-6447 lholmber@fhcrc.org

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Leona A. Holmberg, MD, PhD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Fred Hutchinson Cancer Research Center ( Leona A. Holmberg )
Study ID Numbers:	CDR0000633628, FHCRC-2150.00, IR-6846
Study First Received:	January 30, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00833534 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
stage I small lymphocytic lymphoma

stage III small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
contiguous stage II small lymphocytic lymphoma
noncontiguous stage II small lymphocytic lymphoma

Study placed in the following topic categories:

Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Lenalidomide
Leukemia
Lymphatic Diseases

Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Antirheumatic Agents
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Lymphoma

Additional relevant MeSH terms:

Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Lenalidomide
Pharmacologic Actions

Leukemia
Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Antirheumatic Agents
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on August 28, 2009