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FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years
This study is ongoing, but not recruiting participants.
First Received: November 14, 2005   Last Updated: February 11, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
OSI Pharmaceuticals
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00254410
  Purpose

The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and mitoxantrone plus rituximab, with the growth factor pegylated filgrastim, will improve the response to treatment, and increase the time this response lasts, for patients with previously untreated CLL. The safety of this combination will also be studied.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Mitoxantrone
Drug: Rituximab
Drug: Filgrastim
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase 2 Study of the Activity and Safety of Fludarabine, Cyclophosphamide, and Mitoxantrone Plus Rituximab (FCM-R) With Pegfilgrastim (Neulasta) as Frontline Therapy for Patients < 70 Years With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To determine the clinical response rate (combined morphological [NCI WG criteria] and flow cytometry criteria) following treatment with FCM-R in patients with previously untreated CLL. [ Time Frame: March 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the molecular response rate (PCR for IgH rearrangements) following treatment with FCM-R in patients with previously untreated CLL. [ Time Frame: March 2009 ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2005
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Fludarabine Cyclophosphamide Mitoxantrone Rituximab Pegylated Filgrastim
Drug: Fludarabine
Fludarabine 25mg/m2/day 2,3,4 i.v. 5-30 mins.
Drug: Cyclophosphamide
Cyclophosphamide 250mg/m2/day 2,3,4 i.v. 5-30 mins.
Drug: Mitoxantrone
Mitoxantrone 6mg/m2/day 2 i.v. 30-60 mins.
Drug: Rituximab
Rituximab 375mg/m2/day 1 i.v. 2-6 hours
Drug: Filgrastim
Pegylated Filgrastim - 6mg on day 4,s.c.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Untreated CLL, CLL/PLL, or SLL (small lymphocytic lymphoma) with indication for therapy (Indications for therapy include at least one of the following: i) one or more disease-related symptoms [fever, night sweats, weight loss, pronounced fatigue]; ii) advanced stage disease (Rai stage >/= 3 or Binet stage C); iii) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; iv) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; iv) recurrent infections; v) rapid lymphocyte doubling time of < 6 months).
  • Age < 70 years.
  • Adequate liver function (total bilirubin </= 2.5 mg/dL, SGPT </=4 x ULN) and renal function (serum creatinine </= 2.0 mg/dL). Patients with renal or liver dysfunction due to suspected organ infiltration by lymphocytes may be eligible after discussion with the Principal Investigator, but upper limits for creatinine even under these circumstances must be creatinine < 3mg/dL and bilirubin < 6 mg/dL. Patients with Gilbert's syndrome may be entered on study with bilirubin levels </= 4 mg/dL.
  • Beta-2-microglobulin </= 4 mg/dL.
  • ECOG performance status </= 2.
  • Signed informed consent in keeping with the policies of the hospital.
  • Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female patients of childbearing potential (non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized) need a negative serum or urine pregnancy test within 14 days of study enrollment.

Exclusion Criteria:

  • Active hepatitis B (at least one of the following markers positive: HBsAg, HBeAg, IgM anti-HBc, HBV DNA).
  • Concurrent chemotherapy or immunotherapy.
  • Pregnant patients.
  • History of HIV
  • Symptomatic CNS disease
  • Symptomatic heart disease (NYHA class >/= 3) or LV ejection fraction < 40% (by MUGA or echocardiogram)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254410

Locations
United States, Texas
U.T. M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
OSI Pharmaceuticals
Investigators
Principal Investigator: Stefan H Faderl, MD U.T. M. D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: The University of Texas M. D. Anderson Cancer Center ( Dr. Stefan Faderl, MD/Associate Professor )
Study ID Numbers: 2005-0106
Study First Received: November 14, 2005
Last Updated: February 11, 2009
ClinicalTrials.gov Identifier: NCT00254410     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
Untreated
Fludarabine
Fludara
Cyclophosphamide
Cytoxan
Mitoxantrone
Novantrone
Rituximab
Rituxan
Pegylated Filgrastim
Neupogen

Study placed in the following topic categories:
Antimetabolites
Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Cyclophosphamide
Fludarabine monophosphate
Immunosuppressive Agents
Leukemia
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Peripheral Nervous System Agents
Analgesics
Antineoplastic Agents, Alkylating
Mitoxantrone
Fludarabine
Antirheumatic Agents
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Alkylating Agents

Additional relevant MeSH terms:
Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Leukemia
Sensory System Agents
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Analgesics
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Rituximab
Fludarabine monophosphate
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Myeloablative Agonists
Peripheral Nervous System Agents
Fludarabine
Mitoxantrone
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Leukemia, B-Cell

ClinicalTrials.gov processed this record on September 02, 2009