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.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00254410
First received: November 14, 2005
Last updated: August 24, 2012
Last verified: August 2012
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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: | 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:
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 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Fludarabine 25mg/m2/day 2,3,4 i.v. 5-30 mins. Cyclophosphamide 250mg/m2/day 2,3,4 i.v. 5-30 mins. Mitoxantrone 6mg/m2/day 2 i.v. 30-60 mins. Rituximab 375mg/m2/day 1 i.v. 2-6 hours. Pegylated Filgrastim - 6mg on day 4,s.c.
|
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:
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: | August 24, 2012 |
| 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 23, 2013