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

• ClinicalTrials.gov Identifier: NCT00833534
• Recruitment Status: Withdrawn
• First Posted: February 2, 2009
• Last Update Posted: March 6, 2015
• Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by: Fred Hutchinson Cancer Research Center

Tracking Information

• First Submitted Date: January 30, 2009
• First Posted Date: February 2, 2009
• Last Update Posted Date: March 6, 2015
• Study Start Date: February 2009
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: January 30, 2009)

• Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy
• Disease-free survival at 2 years after transplant

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00833534 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: January 30, 2009)

• Toxicity during consolidation and maintenance therapy as assessed by NCI CTCAE v3.0
• Ability to complete planned therapy
• Complete hematological remission, including bone marrow IgH remission status as assessed by PCR after consolidation and maintenance therapy
• Time to disease progression
• Relapse rates

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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

Brief Summary

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.

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Leukemia
• Lymphoma

Intervention

• Biological: rituximab
  Given IV
• Drug: lenalidomide
  Given orally

Study Arms

• Experimental: Group I (consolidation phase)
  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.
  Intervention: Drug: lenalidomide
• Experimental: Group II (consolidation phase)
  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.
  Interventions:

  • Biological: rituximab
  • Drug: lenalidomide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: March 4, 2015): 0
• Original Estimated Enrollment (submitted: January 30, 2009): 20
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00833534
• Other Study ID Numbers: 2150.00; P30CA015704 ( U.S. NIH Grant/Contract ); FHCRC-2150.00; IR-6846; CDR0000633628 ( Registry Identifier: PDQ )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Leona A. Holmberg, Fred Hutchinson Cancer Research Center
• Study Sponsor: Fred Hutchinson Cancer Research Center
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Leona A. Holmberg, MD, PhD; Fred Hutchinson Cancer Research Center

• PRS Account: Fred Hutchinson Cancer Research Center
• Verification Date: March 2015