MDACC Study Summary 2006-0725 (Archived)

Study Summary
No. 2006-0725:.......Leukemia......Alessandra Ferrajoli......Leukemia

Study Summary Title



Study Summary Number:	2006-0725

Study Title:	A Phase 1/2, Multi-Center, Open-Label Study of the Safety and Efficacy of a Stepwise Dose-Escalation Schedule of Lenalidomide Monotherapy in Subjects with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

Physician

New Patient Referral



Name:	Alessandra Ferrajoli	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:	713-792-2063 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Days 2, 4, and 6 of first cycle of the 5, 10, 15mg doses. Weekly for initial 4 cycles and for first cycle of each dose escalation. Monthly starting cycle 5 (with exception of first cycle of each escalation dose).

Treatment Agents:	Lenalidomide	Home Care:	None

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	One day at each visit.


Description/ Intervention:	The goal of this clinical research study is to learn if Revlimid® (lenalidomide) can help to control B-cell CLL in patients whose disease has come back after receiving prior chemotherapy treatment. The safety of this drug will be studied. The study will also evaluate the effects (good and bad) of giving patients a steadily increasing dose of lenalidomide.

Study Objectives / Outcomes

Objectives:

Primary: Phase 1: To evaluate the safety of lenalidomide when administered by a stepwise dose escalation schedule in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL). Phase 2: To evaluate the safety of lenalidomide administered by a continuous daily regimen versus that of lenalidomide administered by a cyclic regimen in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL).

Secondary: Phase 1: To evaluate the efficacy of a stepwise dose-escalation schedule of lenalidomide in subjects with relapsed or refractory B-cell CLL. Phase 2: To evaluate the efficacy of lenalidomide administered by a continuous daily regimen versus that of lenalidomide administered by a cyclic regimen in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL).

Study Status Information



Study Activation / Registration Date:	05/16/2007

IRB Review and Approval Date:	05/16/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	50

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) · Must understand and voluntarily sign an informed consent form.

2) · Must be 18 years of age or older at the time of signing the informed consent form.

3) · Must be able to adhere to the study visit schedule and other protocol requirements.

4) · Must have a documented diagnosis of B-cell CLL (NCI-WG criteria) that has relapsed after or is refractory to at least one prior regimen. The prior treatment regimen(s) must have included: - An alkylating agent (e.g., chlorambucil or cyclophosphamide) and; - Fludarabine (subjects must have developed disease progression (NCI -WG criteria) either during fludarabine-containing treatment or within 12 months of completing their most recent fludarabine-containing regimen [as measured from the completion of the last treatment cycle].

5) · Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.

6) · Females of childbearing potential (FCBP)TP†PT must have a negative medically supervised pregnancy test prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices complete and continued sexual abstinence.

7) Continuation: FCBP must either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.

8) Male subjects must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. Males must agree to not donate semen or sperm during study therapy and for a period after end of study drug therapy.

9) All subjects must have an understanding that the study drug could have a potential teratogenic risk, agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy, and agree not to share study medication with another person. All subjects must be counseled about pregnancy precautions and risks of fetal exposure.

Exclusion Criteria:

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

2) · Pregnant or lactating females.

3) · Systemic treatment for B-cell CLL within 28 days of randomization.

4) · Subjects with central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging and subjects with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within two weeks prior to randomization.

5) · Prior history of malignancy other than CLL (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for 3 years.

6) · Known HIV-1 positivity.

7) · Prior therapy with lenalidomide.

8) · Any of the following laboratory abnormalities: - ANC < 1000/microliter (1 X 10[9]/L) - Platelet count < 50,000/microliter (50 x 10[9]/L) - Calculated (method of Cockroft-Gault) creatinine clearance <60mL/min.Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0x upper limit of normal (ULN) - serum total bilirubin > 2.0 mg/dL

9) · Prior allergic reaction to thalidomide or prior desquamating (blistering) rash while taking thalidomide.

10) · neuropathy grade 2 or higher.

11) · Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.

12) · Richter's Transformation (active)

13) History of renal failure requiring dialysis.

14) Alemtuzumab therapy within 56 days of initiating lenalidomide treatment.

15) Evidence of TLS per the Cairo-Bishop definition of laboratory TLS. Subjects may be enrolled upon correction of electrolyte abnormalities.

16) Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy.

17) Known presence of alcohol and/or drug abuse.

Links

Registration Number: NCT00419250
Study Information on Clinical Trials Registry (clinicaltrials.gov)