Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.
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ClinicalTrials.gov Identifier: NCT00131313 |
Recruitment Status : Unknown
Verified August 2005 by East Valley Hematology and Oncology Medical Group.
Recruitment status was: Recruiting
First Posted : August 18, 2005
Last Update Posted : August 18, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Lymphocytic Leukemia | Drug: Nipent, Cytoxan, Rituxan | Phase 4 |
Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S. Recent experience with Nipent in conjunction with Rituxan has shown that this combination is well tolerated and is clinically promising. It is expected that the addition of Cytoxan in patients with previously untreated CLL and patients who have relapsed or failed prior therapy may benefit from combined therapy using Nipent, Cytoxan and Rituxan. It is unknown how the addition of Cytoxan will affect the toxicity profile of the Rituxan and Nipent regimen, however, patients will be monitored for toxicities. It is expected that bone marrow toxicities will not increase to unreasonable levels.
The primary objective of the study is to determine the overall efficacy response rate following treatment with Nipent, Cytoxan and Rituxan of patients with previously untreated or treated CLL. The secondary objectives of the study are to determine the duration of response, time to progression, time to treatment failure and to evaluate the toxicity of this combination of drugs and the incidence and severity of adverse events.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 180 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia. |
Study Start Date : | January 2003 |
Study Completion Date : | April 2009 |

- Efficacy response rate
- Time to progression
- Time to treatment failure
- Toxicity
- Incidence and severity of adverse events

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stage II, III or IV Chronic Lymphocytic Leukemia
- Disease requires chemotherapeutic treatment
- CT or MRI scan confirming measurable tumor size
- Documentation of CD markers
- Up to one prior treatment regimen
- Expected survival greater than 6 months
- ECOG performance status of 0-2
- Adequate renal, bone marrow and liver functions
- Negative pregnancy test (females of childbearing potential)
- Must agree to use acceptable birth control, if fertile
- Must complete Informed Consent
- No heart disease and must have adequate cardiac function
- Must test negative for viral Hepatitis B and C
Exclusion Criteria:
- More than one prior treatment for Chronic Lymphocytic Leukemia
- Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs
- Known HIV or AIDS illness
- Thyroid disease requiring medication
- History of any malignancy that could affect the diagnosis or assessment of the study treatment
- Pregnancy or breast feeding
- Evidence of Hepatitis B or C infection
- Inability to comply with the requirements of the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131313
Contact: Tracy Latimer | 720-917-7478 | tracyl@pharmatech.com |

Principal Investigator: | Raul Mena, MD | East Valley Hematology and Oncology Group |
ClinicalTrials.gov Identifier: | NCT00131313 |
Other Study ID Numbers: |
POI-02818 NIP-02-005 |
First Posted: | August 18, 2005 Key Record Dates |
Last Update Posted: | August 18, 2005 |
Last Verified: | August 2005 |
Leukemia Cancer Nipent Rituxan Cytoxan |
Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Cyclophosphamide |
Rituximab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological |