MDACC Study Summary 2004-0373 (Archived)

Study Summary
No. 2004-0373:.......Leukemia......William G. Wierda......Leukemia

Study Summary Title



Study Summary Number:	2004-0373

Study Title:	A Phase I-II Study of Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Patients with Richter's Transformation, Prolymphocytic Leukemia or Refractory/Relapsed B-Cell Chronic Lymphocytic Leukemia

Physician

New Patient Referral



Name:	William G. Wierda	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-0428 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Every 2-3 chemotherapy cycles

Treatment Agents:	Cytarabine Fludarabine Oxaliplatin Rituximab	Home Care:	Supportive care: antibiotics, transfusions, etc.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Approximately 5 days to 6 weeks

Description/
Intervention:

The goal of this clinical research study is to find the highest dose of
oxaliplatin when used in combination with standard doses of rituximab,
fludarabine, and cytarabine, that can be given safely. Once the best safe dose
for this drug combination is found, the next goal of the study will be to find
out if the addition of oxaliplatin increases the activity of rituximab,
fludarabine and cytarabine in shrinking or slowing the growth of CLL,
prolymphocytic leukemia, or Richter's transformation. Richter's syndrome is
the development of high-grade non-Hodgkin's lymphoma, and rarely prolymphocytic
leukemia, Hodgkin's disease, or acute leukemia in patients with chronic
lymphocytic leukemia/small lymphocytic lymphoma.

Study Objectives / Outcomes

1.1 Primary Objectives

Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of oxaliplatin in combination with fludarabine, Ara-C and rituximab in patients with Richter's transformation, prolymphocytic leukemia (PLL), or refractory/relapsed B-cell chronic lymphocytic leukemia (CLL).

Assess the complete response (CR) and partial response (PR) rate to combination therapy of oxaliplatin, fludarabine, Ara-C and rituximab in patients with Richter's transformation, PLL or refractory/relapsed B-cell CLL.

Determine the safety and toxicity profile of combination therapy of oxaliplatin, fludarabine, Ara-C and rituximab in patients with Richter's transformation, PLL or refractory/relapsed B-cell CLL.

1.2 Secondary Objectives

Determine the duration of response, failure-free survival, and overall survival.

Determine the incidence of infections (bacterial, fungal, and viral) in patients with Richter's transformation, prolymphocytic leukemia or refractory/relapsed B-cell CLL treated with rituximab, oxaliplatin, fludarabine and Ara-C; monitor immune parameters such as T cell counts and immunoglobulin levels; and monitor Epstein-Barr virus (EBV) status.

Characterize the pharmacodynamics of oxaliplatin in leukemia cells with respect to total adduct formation, cross-link formation and excision DNA responses. Compare these parameters in cells from the same patient after treatment with oxaliplatin in combination with fludarabine and Ara-C.

Study Status Information



Study Activation / Registration Date:	11/05/2004

IRB Review and Approval Date:	06/02/2004

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	52

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) Histologically or cytologically confirmed Richter's transformation, fludarabine-refractory chronic lymphocytic leukemia or prolymphocytic leukemia.

2) Patients must be 18 years of age or older.

3) Patients must have a performance status of 0-2 (Zubrod scale).

4) Patients must have adequate renal function (serum creatinine below or equal to 2mg/dL or creatinine clearance greater than 30mL/min), unless renal dysfunction is considered due to organ infiltration by disease.

5) Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; SGOT or SGPT less than or equal to 3 X the ULN for the reference lab unless considered due to leukemia or congenital hemolytic disorder (for bilirubin).

6) Female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception.

7) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.

8) Patients must have platelet counts greater or equal to 20,000, unless due to disease involvement, or autoimmune disorders.

Exclusion Criteria:

1) Untreated or uncontrolled life-threatening infection.

2) Oxaliplatin, fludarabine, cytarabine or rituximab intolerance.

3) Pregnancy or lactation.

4) Chemotherapy and/or radiation therapy within 4 weeks.

5) Medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

Links

Registration Number: NCT00452374
Study Information on Clinical Trials Registry (clinicaltrials.gov)