MDACC Study Summary 2004-0223

Study Summary
No. 2004-0223:.......Leukemia......Farhad Ravandi-Kashani......Leukemia

Study Summary Title



Study Summary Number:	2004-0223

Study Title:	PHASE II STUDY OF 2-CHLORODEOXYADENOSINE (2CDA) FOLLOWED BY RITUXIMAB IN HAIRY CELL LEUKEMIA

Physician

New Patient Referral



Name:	Farhad Ravandi-Kashani	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:	713-792-7305 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Daily for 5 days, then weekly for 8 weeks then every three months for first year. Patients can receive their treatment locally after the first dose of both agents has been administered at M.D. Anderson.

Treatment Agents:	2-Chlorodeoxyadenosine Rituximab	Home Care:	Patients can receive their 2CDA and Rituximab treatment locally after the first dose of both agents has been administered at M.D. Anderson.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	No hospitalization required.


Description/ Intervention:	The goal of this clinical research study is to learn if treatment with 2CDA (cladribine) followed by treatment with rituximab can help to control HCL. The safety of this combination treatment will also be studied.

Study Objectives / Outcomes

1. To demonstrate the efficacy in achieving complete response of combination of Cladribine administered intravenously over 2 hours for 5 days followed by Rituximab weekly for 8 weeks in patients with untreated or previously treated hairy cell leukemia.

2. To examine the efficacy of Rituximab to eradicate minimal residual disease (MRD) after Cladribine therapy (as assessed by immunophenotyping of bone marrow and peripheral blood).

3. To examine the effect of addition of Rituximab to Cladribine on the long term disease-free (DFS) and overall survival (OS)(as compared with historical controls)

4. To evaluate potential predictors of outcome including molecular and flow evaluations of MRD, as well as other potential molecular predictors such as BRAF

Study Status Information



Study Activation / Registration Date:	06/10/2004

IRB Review and Approval Date:	05/19/2004

Study Type:	Therapeutic

Recruitment Status:	Open

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) Age 18 years and older

2) Diagnosis of HCL established by bone marrow examination

3) Patients with relapsed disease are eligible if they have had no more than one prior therapy

4) Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study

5) Performance status </= 3

6) Adequate renal function: creatinine less than or equal to 2.0 unless related to the disease

7) Adequate liver function: bilirubin less than or equal to 3.0, transaminases less than or equal 3 x upper limit of normal unless related to the disease

8) No prior investigational agent in the 4 weeks prior to initiation of therapy

Exclusion Criteria:

1) Unable or unwilling to sign the consent form

2) Known infection with HIV, hepatitis B or C

3) Presence of active infection

4) Presence of CNS metastases

5) New York Heart Association Classification III or IV heart disease (See Appendix I)

6) Prior chemotherapy (last 4 weeks)

Links

Registration Number: NCT00412594
Study Information on Clinical Trials Registry (clinicaltrials.gov)