AzTrials
AzTrials

LymphomaPhase 2NCT00496873

Evaluation of the Safety and Efficacy of Nipent, Cytoxan, and Rituxan

A Phase 2 study testing Cytoxan, Nipent and Rituxan in people with Lymphoma, run by M.D. Anderson 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
Search all trials

Trial summary

The goal of the clinical research study is to learn if treatment with a combination of three drugs, Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin), will help to control the disease in patients with previously untreated non-Hodgkin's lymphoma, CLL, or bulky lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Cytoxan, Nipent and Rituxan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
Jun 2005to Dec 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically or cytologically proven, stage III or IV, low-grade B-cell NHL, as defined by the updated WHO modification of the REAL classification for peripheral B-cell neoplasms: B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma; Lymphoplasmacytic lymphoma/immunocytoma; Follicular lymphoma; Extranodal marginal zone B-cell lymphoma of MALT type; Nodal marginal zone B-cell lymphoma (+/- monocytoid B-cells); Lymphoma with primarily bone marrow-only disease are considered eligible
  • Bulky lymphoma or Stage II disease requiring chemotherapy will be considered for enrollment with documented Sponsor Investigator approval prior to registration.
  • CT or MRI scans confirming measurable tumor size (lymph node must be >1cm in its longest transverse diameter). Measurement by physical exam is acceptable in the case of palpable and reproducibly measurable axillary or other superficial tumors.
  • Positive expression of cluster of differentiation antigen 20 (CD20) by biopsy or circulating lymphocytes.
  • Zero or one prior chemotherapeutic or immunotherapeutic treatment regimen for B-cell NHL.
  • Male or female greater than or equal to 18 years of age.
Show all 14Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Adequate renal function: Creatinine less than 1.5 mg/dL; blood urea nitrogen (BUN) less than 30 mg/dL or a creatinine clearance greater than or equal to 60 mL/min based on calculation of creatinine clearance using the Cockcroft-Gault method or from a 24-hour urine collection. Creatinine clearance 40- 59 mL/min from a 24-hour urine collection would require a Nipent dose reduction of 25%. Patients with a Creatinine clearance <40 mL/min from a 24-hour urine collection will be excluded.
  • Adequate bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,000 cells/µL; Platelet count greater than or equal to 75,000 cells/µL; Hemoglobin greater than or equal to 9 g/dL. Patients with idiopathic thrombocytopenia or autoimmune hemolytic anemia are eligible with prior approval of Sponsor Investigator.
  • Adequate liver function: Bilirubin less than or equal to 2.0 mg/dL; AST and ALT less than or equal to 5 times upper limit of normal (ULN).
  • Adequate cardiac function in the judgment of the Investigator, including New York Heart Association (NYHA) classification of I or II.
  • Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration.
  • Patient agrees to use an acceptable method of birth control, if fertile patient (male or female), to avoid pregnancy for the duration of the study and for at least 3 months thereafter.
  • Completed Patient Informed Consent Form.

Who cannot join

  • Previous or current intermediate or high-grade lymphoma.
  • White blood cell count (WBC) greater than 30,000 cells/µL.
  • Received prior therapy using Rituxan, unless such therapy was completed at least 6 months prior to study registration. Patients whose disease was non-responsive to prior Rituxan therapy will be excluded.
  • Known sensitivity to Nipent, Rituxan, Cytoxan or any component of these drugs.
  • Patient received replacement steroid therapy less than 4 weeks prior to study registration.
  • History of other malignancy that could affect the diagnosis or assessment of the study treatment.
Show all 10Show fewer
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) illness.
  • Known prior history of and/or active viral hepatitis (HBV or HCV).
  • Patient is unable to comply with the requirements of this study.
  • Patients with Richter's transformation will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Single-Center, Open-Label Study to Evaluate the Safety and Efficacy of Nipent, Cytoxan, and Rituxan ("PCR") in the Treatment of Previously Untreated and Treated, Stage III or IV, Low-Grade B-Cell Non-Hodgkin's Lymphoma or Bulky Lymphoma

The goal of the clinical research study is to learn if treatment with a combination of three drugs, Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin), will help to control the disease in patients with previously untreated non-Hodgkin's lymphoma, CLL, or bulky lymphoma. The safety of this treatment will also be studied.

Read the detailed description

All of the drugs [Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin)] in this study are commonly used in the treatment of this cancer. However, using these drugs in combination is investigational.

Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. You will have blood collected (around 2-3 tablespoons) for routine tests. You will have a chest x-ray and CT scans of the chest, abdomen (stomach), and pelvis (waist area). Tumors will be measured using x-rays. You will have a sample of bone marrow collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. If your doctor feels it is necessary, you may also have lymph node biopsy samples taken for special tests. Women who are able to have children must have a negative blood or urine pregnancy test.

During treatment you will be given a combination of three drugs in a 21 day (3 weeks) cycle. All drugs will be given through a needle in a vein over 4-6 hours. You will receive pentostatin first, then rituximab, and lastly cyclophosphamide. For each treatment cycle cyclophosphamide, rituximab, and pentostatin will be given on Day 1, followed by 20 days of rest.

During treatment, you will have around 2-3 tablespoons of blood collected at least once a week for routine tests. You will also provide a urine sample for routine urine tests. Depending on how the disease responds, treatment may be stopped after 3, 6, or 9 cycles. You will be taken off treatment if your disease gets worse. If your treatment is delayed for more than 2 weeks due to any side effect related to the treatment or for more than 3 weeks for any reason, you will be taken off of this study. If your doctor feels that you are having serious or intolerable side effects that are not improved by standard supportive care methods (such as medicine to control nausea or a transfusion to treat anemia) you will be taken off of this study.

After Cycles 3, 6, and 9, tumors will be measured using x-rays or other scans (CT or MRI). Bone marrow samples will be taken if they are needed to find out if the drug combination is working to control your disease.

The maximum number of cycles that you can receive is 9. If you wish to continue using this drug treatment, and it is beneficial to do so, you may continue to receive these drugs. However, these drugs are commercially available, so you will be financially responsible for the cost of these drugs.

After you receive the last cycle of chemotherapy, your doctor will decide your schedule of follow-up exams. You will have follow-up exams every 3 months for one year, every 6 months for 2nd year, then once after 1 year. During these exams, you will have a chest x-ray and CT scans of the chest, abdomen (stomach), and pelvis (waist area). You will also have blood collected (2-3 tablespoons) for routine tests.

This is an investigational study. All of the study drugs are approved by the FDA for cancer treatment and are commercially available. However, the use of the drugs in combination is investigational. Up to 100 patients will take part in this study. All enrolled will be at M. D. Anderson.

Conditions
Lymphoma
Being tested
Cytoxan, Nipent, Rituxan
Keywords
Non-Hodgkin's Lymphoma, NHL, Lymphoma, B-cell chronic lymphocytic leukemia, SLL, Small Lymphocytic Lymphoma, Lymphoplasmacytic lymphoma/immunocytoma, Follicular lymphoma, Extranodal marginal zone B-cell lymphoma of MALT type, Nodal marginal zone B-cell lymphoma, Chronic Lymphocytic Leukemia, CLL, Bulky Lymphoma, Nipent, Cytoxan, Rituxan, Cyclophosphamide, Rituximab, Pentostatin
Medical subject headings
Lymphoma, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular

What participants receive

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

  • CytoxanDrug

    Also called Cyclophosphamide, Neosar

    600 mg/m^2 on Day 1 of 21-day cycle.

  • NipentDrug

    Also called Pentostatin, Deoxycoformycin, DCF

    4 mg/m^2 on Day 1 of 21 Day Cycle.

  • RituxanDrug

    Also called Rituximab

    375 mg/m^2 on Day 1 of 21 Day Cycle.

Study groups in NCT00496873
Study groupRoleWhat they receive
Cytoxan + Rituxan + NipentExperimentalCytoxan 600 mg/m^2 on Day 1 of 21-day cycle. Rituxan 375 mg/m^2 on Day 1 of 21 Day Cycle. Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
Receives: Drug: Cytoxan; Drug: Nipent; Drug: Rituxan

What is being measured

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

  1. Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999

    Number of participants with response out of total treated participants using IWG defined 6 categories based on IWG 1999 Response Criteria for NHL of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD). CR: is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. PR: is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions. SD: participants who have achieved less than a PR but who have not developed findings consistent with progressive disease.

    Measured: Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months

  2. Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu) With Low-grade Lymphoma (N=83) After 6-9 Cycles of PCR Therapy

    Number of participants with response according to the International Working Group (IWG) anatomic criteria for assessing six categories of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD), relapsed disease (RD), and progressive disease (PD). Response was assessed after 3, 6, and 9 cycles of therapy.

    Measured: 9 cycles of 21 days, up to 7 months

Secondary outcomes (1)

  1. 3-Year Progression-Free Survival

    Progression-free survival (PFS) was defined as time from initiation of therapy to progression of disease or death, whichever occurred first. The Kaplan-Meier method was used to estimate PFS.

    Measured: PFS assessed 7 days prior to every cycle and then every 3 months after off-treatment for one year, every 6 months for second year, then once on third year

Timeline

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

  1. First posted4 Jul 2007 (estimated)
  2. Study startJun 2005
  3. Primary completionDec 2014
  4. Study completionDec 2014

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
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00496873
Sponsor's protocol ID
2004-0818
Other IDs
NCI-2010-00635
Status last verified
Mar 2023
First submitted
3 Jul 2007
Last updated
29 Mar 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytoxan, Nipent and Rituxan in people with Lymphoma, run by M.D. Anderson 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 14 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 29 Mar 2023. 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?

Yes. Results are posted in the registry (first posted 23 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 (time frame: Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months). The study lists 2 primary outcomes in all. 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 NCT00496873.

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 29 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in