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B-Chronic Lymphocytic LeukemiaPhase 2NCT00201721

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

A Phase 2 study testing Pentostatin, Rituximab and Cyclophosphamide in people with B-Chronic Lymphocytic Leukemia, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Chronic Lymphocytic Leukemia
What is being tested?
Pentostatin, Rituximab and Cyclophosphamide
Type of treatment
Injection or infusion
How many people
28 participants
Where
1 siteUnited States
Study dates
Jul 2002to Sep 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of B-CLL (no mantle cell)
  • Must have active disease
  • Age >=18 yo
  • ECOG 0-3
  • No radiation or surgery <4 weeks

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

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

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

Read the detailed 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.

Being tested
Pentostatin, Rituximab, Cyclophosphamide
Keywords
Previously Untreated
Medical subject headings
Leukemia, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PentostatinDrug

    Also called Nipent®

    2 mg/m2 IV over 30 minutes in 250 mL NS on day 1 during cycles 1-6.

  • RituximabDrug

    Also called RITUXAN®

    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.

  • CyclophosphamideDrug

    Also called CTX

    600 mg/m2 IV in 250 mL NS over 30 minutes on day 1 cycles 1-6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 5 years

Secondary outcomes (1)

  1. To monitor and assess toxicity of this regimen.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startJul 2002
  3. Primary completionJul 2006
  4. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00201721
Sponsor's protocol ID
OSU-0143
Status last verified
Feb 2017
First submitted
12 Sep 2005
Last updated
8 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. doi: 10.1182/blood-2006-07-033274. Epub 2006 Sep 28.

    PubMed 17008537

  • 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: 10.1002/cncr.25028.

    PubMed 20187101

  • 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. doi: 10.1002/cncr.22662.

    PubMed 17514743

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pentostatin, Rituximab and Cyclophosphamide in people with B-Chronic Lymphocytic Leukemia, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide. (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00201721, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.

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