FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	OSI Pharmaceuticals
Information provided by (Responsible Party):	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 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Cyclophosphamide Fludarabine Mitoxantrone Mitoxantrone hydrochloride Fludarabine phosphate Filgrastim Lenograstim Granulocyte colony-stimulating factor Rituximab

U.S. FDA Resources

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

Primary Outcome Measures:

Clinical Response Rate (combined morphological [NCI WG criteria] + flow cytometry criteria) following treatment with FCM-R [ Time Frame: End of cycle 3 and 6. ] [ Designated as safety issue: No ]
Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy.

Secondary Outcome Measures:

Molecular response rate (PCR for IgH rearrangements) following treatment with FCM-R [ Time Frame: End of cycle 3 and 6. ] [ Designated as safety issue: No ]
Courses will be repeated every 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and toxicities for a maximum of 6 courses. Patients will be evaluated for response after 3 and 6 courses. Bone marrow biopsies will be performed at the end of Cycles 3 and 6 of chemotherapy

Enrollment:	31
Study Start Date:	March 2005
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Fludarabine Cyclophosphamide Mitoxantrone Rituximab Pegylated Filgrastim	Drug: Fludarabine Fludarabine 25mg/m2/day 2,3,4 i.v. 5-30 mins. Other Name: Fludara® Drug: Cyclophosphamide Cyclophosphamide 250mg/m2/day 2,3,4 i.v. 5-30 mins. Other Name: Cytoxan® Drug: Mitoxantrone Mitoxantrone 6mg/m2/day 2 i.v. 30-60 mins. Other Name: Novantrone® Drug: Rituximab Rituximab 375mg/m2/day 1 i.v. 2-6 hours Other Name: Rituxan® Drug: Filgrastim Pegylated Filgrastim - 6mg on day 4,s.c. Other Name: Neupogen®

Arms

Assigned Interventions

Experimental: 1

Fludarabine Cyclophosphamide Mitoxantrone Rituximab Pegylated Filgrastim

Drug: Fludarabine

Fludarabine 25mg/m2/day 2,3,4 i.v. 5-30 mins.

Other Name: Fludara®

Drug: Cyclophosphamide

Cyclophosphamide 250mg/m2/day 2,3,4 i.v. 5-30 mins.

Other Name: Cytoxan®

Drug: Mitoxantrone

Mitoxantrone 6mg/m2/day 2 i.v. 30-60 mins.

Other Name: Novantrone®

Drug: Rituximab

Rituximab 375mg/m2/day 1 i.v. 2-6 hours

Other Name: Rituxan®

Drug: Filgrastim

Pegylated Filgrastim - 6mg on day 4,s.c.

Other Name: Neupogen®

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
UT MD 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

M.D. Anderson Cancer Center

More Information

Additional Information:

M. D. Anderson Cancer Center's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00254410 History of Changes
Other Study ID Numbers:	2005-0106
Study First Received:	November 14, 2005
Last Updated:	September 2, 2011
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

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine monophosphate
Rituximab
Fludarabine
Mitoxantrone

Lenograstim
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on May 24, 2012