Gemcitabine in Treating Patients With Recurrent Chronic Lymphocytic Leukemia

NCT00005829 | Completed Phase 2

• 4 other identifiers: NCCTG-98-81-52NCCTG-988152CDR0000067843NCI-2012-02331
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent chronic lymphocytic leukemia.

Conditions

Leukemia

Keywords

refractory chronic lymphocytic leukemia; B-cell chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

• confirmed response

  Up to 20 weeks

Secondary Outcomes (3)

• overall survival

  Up to 8 years

• progression free survival

  Up to 8 years

• time to progression

  Up to 8 years

Study Arms (1)

gemcitabine

EXPERIMENTAL

Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 4 weeks for a minimum of 3 courses. Patients achieving clinical complete remission, complete remission, nodular partial remission, or partial remission following 3 courses of therapy, receive 2 additional courses of therapy. Patients achieving complete remission or further improvement following the 2 additional courses of therapy, receive another 2 courses of therapy. Patients are followed every 3 months until disease progression or relapse. Patients achieving complete remission are followed every 6 months for 1 year.

Drug: gemcitabine hydrochloride

Interventions

gemcitabine hydrochloride DRUG

gemcitabine

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Diagnosis of B-cell chronic lymphocytic leukemia manifested by all of the following: Minimum threshold peripheral lymphocyte count of at least 5,000/mm3 Small to medium sized peripheral blood lymphocytes with no greater than 55% prolymphocytes Bone marrow aspirate and biopsy containing at least 30% lymphoid cells Immunophenotypic and biopsy evaluation of peripheral blood lymphocytes demonstrating monoclonality of B lymphocytes B-cell markers with CD5 antigen (e.g., T-1, T-101) in the absence of other pan T-cell markers (e.g., CD3, CD2) Expression of CD19, CD20, and CD23 B cell surface markers B-cell expression of kappa or lambda light chains Active disease with at least one of the following criteria: One or more disease related symptoms: At least 10% weight loss within the past 6 months Fever greater than 100.5 F for at least 2 weeks without evidence of infection Night sweats without evidence of infection Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin less than 11.0 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm3) (i.e., any stage III or IV disease) Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy Massive (i.e., greater than 6 cm below the left costal margin) or progressive splenomegaly (i.e., a greater than 50% increase over two months) Massive (i.e., greater than 10 cm in longest diameter) or progressive lymphadenopathy (i.e., a greater than 50% increase over two months) Progressive lymphocytosis with an increase of greater than 50% over a 2 month period (unrelated to corticosteroids) or an anticipated doubling time of less than 6 months No marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any criteria for active disease Previously treated with at least a fludarabine or cladribine based regimen and a prior alkylating agent with evidence of recurrent or progressive disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN (unless due to hemolysis or chronic lymphocytic leukemia) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No myocardial infarction within the past month Other: No uncontrolled infection HIV negative No other active malignancy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Call TG, Constantinou CL, Kahanic SP, et al.: NCCTG trial of gemcitabine for relapsed B-cell chronic lymphocytic leukemia. [Abstract] J Clin Oncol 22 (Suppl 14): A-6726, 613s, 2004.

  RESULT

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Timothy G. Call, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: June 18, 2004
• Study Start: February 1, 2000
• Primary Completion: October 1, 2002
• Study Completion: April 1, 2008
• Last Updated: December 7, 2016

Record last verified: 2016-12