Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia

B-Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201721
• Other study ID #: OSU-0143
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: February 6, 2017
• Start date: July 2002
• Est. completion date: September 2006

Study information

• Verified date: February 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this regimen, and to determine the overall and progression-free survival in CLL patients

Description:

Rationale: Research indicates that both cyclophosphamide and pentostatin work synergistically against cancer cells and have a high response rate against chronic lymphocytic leukemia (CLL) without creating severe side effects in patients. In addition, studies have shown that rituximab, a therapy that targets the immune system, has the highest efficacy against CLL and the lowest toxicity rate when compared with other immunotherapy drugs. Studies also show that rituximab enhances the efficacy of the chemotherapy agents cyclophosphamide and pentostatin. This study offers the combination of immunotherapy with two promising chemotherapy agents against CLL.

Purpose: This study is evaluating the efficacy and safety of combination treatment with cyclophosphamide, pentostatin, and rituximab in patients with CLL. Several tests evaluating the genetic and molecular components of CLL will also be performed. Some of these tests will be conducted before, during, and after treatments to assess changes resulting from the study drugs. Each patient's outcome will be assessed in relation to various aspects of their genes.

Other known NCT identifiers

• NCT00423423

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of B-CLL (no mantle cell)

• Must have active disease

• Age >=18 yo

• ECOG 0-3

• No radiation or surgery <4 weeks

Exclusion Criteria:

• Any of the following comorbid conditions:

• New York Heart Association Class III or IV heart disease

• Recent myocardial infarction (<1 month)

• Uncontrolled infection

• Active infection with the human immunodeficiency virus (HIV/AIDS) as further severe immunosuppression with this regimen may occur.

• Pregnant or nursing women

• Men or women of child bearing potential must use adequate contraception.

• Active primary malignancy requiring treatment or limits survival to =2 years.

• Any radiation therapy =4 weeks prior to study entry.

• Any major surgery =4 weeks prior to study entry.

Related Conditions & MeSH terms

• B-Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Pentostatin
2 mg/m2 IV over 30 minutes in 250 mL NS on day 1 during cycles 1-6.
• Rituximab
For the first week only: Day 1 of therapy 100 mg IV over 4 hours. Day 3 of therapy 375 mg/m2 IV at 50 mg/hr and increase by 100 mg/hr at 30-minute intervals to a maximum of 400 mg/hr. Day 5 of therapy 375 mg/m2 IV at 100 mg/hr for the first 15 minutes the remainder goes in at 45 minutes. The remaining weeks 375 mg/m2 will be repeated as a single IV infusion Day 1 of Week 4, 7, 10, 13 and 16 during cycles 2-6.
• Cyclophosphamide
600 mg/m2 IV in 250 mL NS over 30 minutes on day 1 cycles 1-6

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Astex Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kay NE, Geyer SM, Call TG, Shanafelt TD, Zent CS, Jelinek DF, Tschumper R, Bone ND, Dewald GW, Lin TS, Heerema NA, Smith L, Grever MR, Byrd JC. Combination chemoimmunotherapy with pentostatin, cyclophosphamide, and rituximab shows significant clinical activity with low accompanying toxicity in previously untreated B chronic lymphocytic leukemia. Blood. 2007 Jan 15;109(2):405-11. — View Citation

Kay NE, Wu W, Kabat B, LaPlant B, Lin TS, Byrd JC, Jelinek DF, Grever MR, Zent CS, Call TG, Shanafelt TD. Pentostatin and rituximab therapy for previously untreated patients with B-cell chronic lymphocytic leukemia. Cancer. 2010 May 1;116(9):2180-7. doi: — View Citation

Shanafelt TD, Lin T, Geyer SM, Zent CS, Leung N, Kabat B, Bowen D, Grever MR, Byrd JC, Kay NE. Pentostatin, cyclophosphamide, and rituximab regimen in older patients with chronic lymphocytic leukemia. Cancer. 2007 Jun 1;109(11):2291-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide.	For this evaluation, patients will be classified as complete responders if either of the following types of response are documented; CCR (Clinically based complete remission) denotes NED (No Evidence of Disease) based on baseline clinical parameters.; CR denotes CCR and, in bone marrow, no nodules and <30% lymphocytes.	up to 5 years
Secondary	To monitor and assess toxicity of this regimen.		up to 5 years

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