Return to List

Study Summary
No. 2005-0106:.......Leukemia......Stefan Faderl......Leukemia
.
Study Summary Title
Study Summary
Number:
2005-0106
Study 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
.
Physician New Patient Referral
Name:Stefan FaderlPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-4613
Contact us about clinical trials
.
General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
At least every 3 months while receiving therapy and 6 to 12 monthly (+/- 3
months) thereafter as long as on study.
Treatment
Agents:
Cyclophosphamide
Fludarabine
Mitoxantrone
Neulasta
Rituximab
Home Care:Chemotherapy courses wil be prescribed by MD Anderson physician or Principal
Investigator. All chemotherapy may be given by local oncologist except for the
induction chemotherapy course.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Maximum of 4 days in Houston.
Description/
Intervention:
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.
.
Study Objectives / Outcomes
Primary:

1. 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.

Secondary:

2. To determine the molecular response rate (PCR for IgH rearrangements) following treatment with FCM-R in patients with previously untreated CLL.
3. To determine time to treatment failure
4. To determine the toxicity profile of FCM-R.
.
Study Status Information
Study Activation / Registration Date:03/14/2005
IRB Review and Approval Date:03/02/2005
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) 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).

2) Age < 70 years.

3) 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.

4) Beta-2-microglobulin </= 4 mg/dL.

5) ECOG performance status </= 2.

6) Signed informed consent in keeping with the policies of the hospital.

7) 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:1) Active hepatitis B (at least one of the following markers positive: HBsAg, HBeAg, IgM anti-HBc, HBV DNA).

2) Concurrent chemotherapy or immunotherapy.

3) Pregnant patients.

4) History of HIV

5) Symptomatic CNS disease

6) Symptomatic heart disease (NYHA class >/= 3) or LV ejection fraction < 40% (by MUGA or echocardiogram)

.
Links
Registration Number: NCT00254410
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center