MDACC Study Summary 2006-0657

Study Summary
No. 2006-0657:.......Leukemia......Gautam Borthakur......Leukemia

Study Summary Title



Study Summary Number:	2006-0657

Study Title:	Phase II Study of Lenalidomide and Darbepoetin alfa in Myelodysplastic Syndrome (Low to Intermediate-1 Risk Category excluding 5q deletion)

Physician

New Patient Referral



Name:	Gautam Borthakur	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:	713-563-1586 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Weekly for 4 weeks then evry 3 month

Treatment Agents:	Darbepoetin alfa Lenalidomide	Home Care:	Lenalidomide will be dispensed to patients to take at home. Patients will get darbepoetin alfa injections at local physician's office or hospitals

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa given together will help to control the need for transfusions in patients with low to intermediate risk MDS. The safety of this combination will also be studied.

Study Objectives / Outcomes

Primary:

Assess rates of red cell transfusion independence achieved with a combination of lenalidomide and darbepoetin alfa in patients with low to intermediate-1 risk MDS (IPSS 0-1) and RBC transfusion dependent anemia defined as no transfusion free interval of >/= 56 consecutive days within the past 112 days.

Secondary:

Evaluate safety and toxicity of a combination of lenalidomide and darbepoetin alfa in patients with low to intermediate-1 risk MDS.
Assess response durations, overall survival, cytogenetic response

Study Status Information



Study Activation / Registration Date:	02/22/2008

IRB Review and Approval Date:	09/20/2006

Study Type:	Phase Ii Or Phase I/Ii

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) Understand and voluntarily sign an informed consent form.

2) Age >/=18 years at the time of signing the informed consent form.

3) Able to adhere to the study visit schedule and other protocol requirements.

4) Have low or intermediate-1 IPSS risk category MDS (excluding 5q deletion)

5) RBC transfusion-dependent anemia defined as no transfusion free interval of >/= 56 consecutive days within the past 112 days.

6) ECOG performance status of 0-2 at study entry.

7) Laboratory test results within these ranges: Serum creatinine </= 1.5 mg/dL ,Total bilirubin </= 1.5 mg/dL ,AST (SGOT) and ALT (SGPT) </= 3 x ULN, ANC >/= 500 /uL, Platelet count >/= 30,000/uL (untransfused)

8) Disease free of prior malignancies for >/=2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast

9) Patients who are on epoetin alfa or darbopoetin prior to enrollment will be allowed to enroll if they have failed such therapy, failure defined as transfusion requiring despite >/= 6 weeks of epoetin alfa at dose of 40,000 units/week and darbopoetin alfa at dose of 150 mcg/ 2 week. No washout period will be necessary. Upon study entry patients receiving epoetin alfa will be switched over to darbopoetin.

10) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10–14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.

11) continued from #10 Men must agree to use a latex condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy.

Exclusion Criteria:

1) Clinically significant anemia owing to iron, B12, or folate deficiencies.

2) Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

3) Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)

4) Concomitant use of steroids will not be allowed unless used for premedication in preparation for transfusions, treatment of hypersensitivity reaction related to lenalidomide or any underlying medical condition other than MDS (e.g. COPD).

5) Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

6) Use of any other experimental drug or therapy within 28 days of baseline.

7) Known hypersensitivity to thalidomide.

8) The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.

9) Any prior use of lenalidomide.

10) Concurrent use of other anti-cancer agents or treatments.

11) Known positive for HIV or infectious hepatitis, type A, B or C.

12) Hypersensitivity to darbepoetin or any component of the formulation (including polysorbate 80 and/or albumin);

13) Uncontrolled hypertension

Links

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