MDACC Study Summary 2007-0871

Study Summary
No. 2007-0871:.......Leukemia......Issa F. Khouri......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2007-0871

Study Title:	Nonmyeloablative Stem Cell Transplantation with or without Lenalidomide for Chronic Lymphocytic Leukemia (RV-CLL-PI-0294)

Physician

New Patient Referral



Name:	Issa F. Khouri	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8750 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Celgene Corporation

Phase of Study:	Phase II	Return Visit:	Every 3 months for the first 18 months. Then every 6 months for 3 years.

Treatment Agents:	Cyclophosphamide Fludarabine Lenalidomide Rituximab Thymoglobulin	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Length of stay in the hospital: 3-4 weeks. Frequency of hospitalization: 2 times over the first year.


Description/ Intervention:	The goal of this clinical research study is to learn if lenalidomide, when given with a stem cell transplant and chemotherapy (cyclophosphamide, fludarabine, and rituximab), can help to control CLL. The safety of this treatment combination will also be studied.

Study Objectives / Outcomes

Primary:

To compare the need for immunomanipulation within 18 months after non-myeloablative allogeneic transplantation for CLL with or without lenalidomide maintenance. For this purpose, "immunomanipulation" is defined as any one of the following events:

1) Cessation of administering tacrolimus treatment within the first 6 months after allotransplant

due to persistent disease or progression.

2) Boost of donor lymphocytic infusion (DLI) administered anytime between 3 and 18 months after allotransplant.

Secondary:

To evaluate:

1) time to treatment failure

2) time to molecular remission

3) safety profile of lenalidomide maintenance

4) acute and chronic graft-vs-host disease rates and

5) percentage of blood donor cell after transplant in the recipient.

Study Status Information



Study Activation / Registration Date:	05/06/2009

IRB Review and Approval Date:	10/31/2008

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) Age 18-75 years at the time of signing the informed consent form.

2) Disease: CLL in relapse, after failing conventional chemo-antibody combination therapy; CLL patients who failed to achieve CR with frontline conventional chemo-antibody; CLL patients with 17p deletion; CLL in Richter's.

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

4) Donor: HLA compatible related (HLA-A,-B,-DRBI matched or with one-antigen mismatched) or HLA compatible unrelated.

5) ECOG performance status of </= 2 at study entry

6) FEV1, FVC and DLCO >/= 40%.

7) Left ventricular EF > 40% with no uncontrolled arrhythmias or symptomatic heart disease.

8) Serum creatinine </= 1.6 mg/dL. Serum bilirubin < 1.6 mg/dL.

9) SGPT < 2x upper limit of normal.

10) Voluntary signed, written IRB-approved informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

11) All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 3 weeks prior to treatment in this study.

12) Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.

13) 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 study entry.

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

3) 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.

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

5) Known hypersensitivity to thalidomide.

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

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

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

9) Active uncontrolled bacterial, viral or fungal infections.

10) Deep-vein thrombosis or pulmonary embolism with 3 months of study entry.

Links

Registration Number: NCT00899431
Study Information on Clinical Trials Registry (clinicaltrials.gov)