Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

rituximab

lenalidomide

About this trial

This is an interventional treatment trial for Leukemia focused on measuring refractory chronic lymphocytic leukemia

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry Relapsed or refractory disease Measurable disease, defined by 1 of the following criteria: Absolute lymphocyte count ≥ 5,000/mm^3 Measurable lymphadenopathy or organomegaly Received ≥ 1 prior therapy for CLL PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 30,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present) Renal Creatinine ≤ 1.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation No known hypersensitivity to thalidomide No erythema nodosum characterized by a desquamating rash after prior thalidomide or similar drug administration No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins No serious medical condition or laboratory abnormality that would preclude study participation No psychiatric illness that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy No prior lenalidomide (CC-5013) No concurrent thalidomide Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No concurrent radiotherapy Surgery Not specified Other At least 4 weeks since prior therapy for CLL At least 28 days since prior experimental drug or therapy No other concurrent anticancer therapies No other concurrent investigational agents

Sites / Locations

Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Lenalidomide

Arm Description

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

Outcomes

Primary Outcome Measures

Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months

Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.

Secondary Outcome Measures

Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab

Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients who have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.

Number of Participants With Adverse Events on Single Agent CC-5013

Number of Participants with Adverse Events on Single Agent CC-5013, Graded According to NCI CTCAE Version 3.0 Please refer to the adverse event reporting for more detail.

Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab

Number of Participants with Adverse Events on Combination Therapy of CC-5013+Rituximab, Graded According to NCI CTCAE Version 3.0

Time to Progression for Single Agent CC-5013

Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.

Time to Progression for the Combination Therapy of CC-5013+Rituximab

Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.

Full Information

NCT ID

NCT00096044

First Posted

November 9, 2004

Last Updated

June 9, 2017

Sponsor

Roswell Park Cancer Institute

Collaborators

Celgene

1. Study Identification

Unique Protocol Identification Number

NCT00096044

Brief Title

Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Official Title

CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

Collaborators

Celgene

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia.

Detailed Description

OBJECTIVES: Primary Determine the best cytostatic response rate (including complete response, partial response, or stable disease) in patients with relapsed or refractory chronic lymphocytic leukemia treated with lenalidomide (CC-5013). Secondary Determine the cytostatic response rate in patients who progress on CC-5013 and are then treated with CC-5013 and rituximab. Determine the safety of these regimens in these patients. Determine time to progression in patients treated with these regimens. OUTLINE: This is an open-label, non-randomized, pilot study. Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond CR. Patients with disease progression receive oral CC-5013 once daily on days 1-21 and rituximab IV on days 1, 8, and 15 during the first treatment course and on days 1 and 15 of all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of further disease progression. Patients who achieve CR receive 2 additional courses beyond CR. Patients are followed at 1 month and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia

Keywords

refractory chronic lymphocytic leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Lenalidomide

Arm Type

Experimental

Arm Description

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity

Intervention Type

Biological

Intervention Name(s)

rituximab

Intervention Description

IV

Intervention Type

Drug

Intervention Name(s)

lenalidomide

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months

Description

Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.

Time Frame

at 6 Months

Secondary Outcome Measure Information:

Title

Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab

Description

Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients who have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.

Time Frame

5 years

Title

Number of Participants With Adverse Events on Single Agent CC-5013

Description

Number of Participants with Adverse Events on Single Agent CC-5013, Graded According to NCI CTCAE Version 3.0 Please refer to the adverse event reporting for more detail.

Time Frame

1 year

Title

Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab

Description

Number of Participants with Adverse Events on Combination Therapy of CC-5013+Rituximab, Graded According to NCI CTCAE Version 3.0

Time Frame

Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab.

Title

Time to Progression for Single Agent CC-5013

Description

Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.

Time Frame

5 years

Title

Time to Progression for the Combination Therapy of CC-5013+Rituximab

Description

Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.

Time Frame

Every month up to 6 months and every 3 months thereafter up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry Relapsed or refractory disease Measurable disease, defined by 1 of the following criteria: Absolute lymphocyte count ≥ 5,000/mm^3 Measurable lymphadenopathy or organomegaly Received ≥ 1 prior therapy for CLL PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 30,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present) Renal Creatinine ≤ 1.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation No known hypersensitivity to thalidomide No erythema nodosum characterized by a desquamating rash after prior thalidomide or similar drug administration No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins No serious medical condition or laboratory abnormality that would preclude study participation No psychiatric illness that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy No prior lenalidomide (CC-5013) No concurrent thalidomide Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No concurrent radiotherapy Surgery Not specified Other At least 4 weeks since prior therapy for CLL At least 28 days since prior experimental drug or therapy No other concurrent anticancer therapies No other concurrent investigational agents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelvin Lee, MD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial