MDACC Study Summary 2006-0321 (Archived)

Study Summary
No. 2006-0321:.......Blood And Marrow Transplantation......Amin Alousi......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2006-0321

Study Title:	A PHASE II STUDY OF LENALIDOMIDE (REVLIMID®) AS SECOND LINE THERAPY IN PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (GVHD)- RV- GVHD -PI- 0092

Physician

New Patient Referral



Name:	Amin Alousi	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:	Blood And Marrow Transplantation	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients will have to return to MDACC at least monthly, or more frequently if clinically indicated

Treatment Agents:	Lenalidomide	Home Care:	N/A

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 Revlimid® (lenalidomide), along with standard-of-care steroid treatment you are already receiving, can help to control cGVHD. The safety of this study drug in combination with the steroids will also be studied.

Study Objectives / Outcomes

Primary:

To assess the response rate of chronic GVHD to Lenalidomide after failing steroids
To evaluate the safety and tolerability of Lenalidomide in patients with chronic GVHD

Secondary:

To assess the steroid-sparing capacity of Lenalidomide (as proportion of patients able to discontinue steroids while receiving or following therapy with Lenalidomide)
To assess changes in QOL after treatment with Lenalidomide
To analyze survival at 6 and 12 months after initiation of Lenalidomide
To evaluate relapse of underlying malignancy as well as second malignancies at 6 and 12 months after initiation of Lenalidomide

Study Status Information



Study Activation / Registration Date:	04/16/2008

IRB Review and Approval Date:	03/16/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

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) Patients with chronic GVHD following allogeneic HSCT of any source (bone marrow, peripheral blood or cord blood stem cells), from any donor type (related, unrelated, mismatched) and with any type of malignancy.

2) Patients must have failed a trial of steroids and calcineurin inhibitors. Steroids must have been given at an initial dose of 1 mg/kg/d of methylprednisolone (MP) or equivalent in combination with tacrolimus or cyclosporine. Steroid refractoriness or resistance will be defined as: 1- Lack of any response after 1 month of treatment with MP, including 15 days of at least 0.5 mg/kg/d, 2- Worsening of existing GVHD or new organ involvement at any time following one week of initiation of MP at 1 mg/kg/day, 3- Reflare or worsening of GVHD at any time during steroid taper.

3) Patients may have received steroids and calcineurin inhibitors (i.e. cyclosporine or tacrolimus) for chronic GVHD. Patients who have previously been treated for chronic GVHD with any other drug or treatment may be enrolled, provided the other drug or treatment was completed >/= 30 days before registration for study entry.

4) ECOG performance status </= 2.

5) WBC >/= 2,500/mm^3, ANC >/= 1,000/mm^3, platelet count >/= 50,000/mm^3

6) Left ventricular ejection fraction >/= 40%. No uncontrolled arrythmias or symptomatic heart disease. FEV1, FVC and DLCO >/= 40%.

7) Serum creatinine <2.0 mg/dL. Serum bilirubin <3 X upper limit of normal, AST (SGOT) and ALT (SGPT) < or = 5 x ULN. No evidence of chronic active hepatitis or cirrhosis.

8) No uncontrolled infections.

9) No evidence of malignancy (patients must be in complete remission from their malignancy)

10) Patients must be able to provide written informed consent, and be 18 years or older at the time of signing consent.

11) Patient must be able to return to clinic for follow up at least every 2 weeks for the first 2 months and at least monthly thereafter.

12) Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 – 14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or agree to use 2 contraceptive methods. These birth control methods must be used for at least 4 weeks before, during and after lenalidomide therapy. Men must agree not to father a child and agrees to use a condom if his partner is of child bearing potential.

13) Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin).

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) 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) Any prior use of Lenalidomide.

8) Use of prior immunosuppressants other than steroids and calcineurin inhibitors (i.e. cyclosporine or tacrolimus).

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

Links

Registration Number: NCT00675441
Study Information on Clinical Trials Registry (clinicaltrials.gov)