MDACC Study Summary 2008-0246

Study Summary
No. 2008-0246:.......Leukemia; Lymphoma......Issa F. Khouri......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2008-0246

Study Title:	Fludarabine, Bendamustine and Rituximab (FBR) Non-myeloablative Allogeneic Conditioning for Patients with Lymphoid Malignancies

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 Lymphoma	Supported By:	Cephalon, Inc.

Phase of Study:	Phase I	Return Visit:	Every 3 months for the first year, then every 6 months while the patient is on study.

Treatment Agents:	Bendamustine HCl Fludarabine Rituximab	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	3-4 weeks in the hospital.


Description/ Intervention:	The goal of this clinical research study is to learn if bendamustine, when given with a stem cell transplant and chemotherapy (fludarabine and rituximab), can help the transplanted stem cells start to grow and make new blood cells in patients with leukemia and lymphoma. The safety of this combination will also be studied.

Study Objectives / Outcomes

Primary Objective:

To determine engraftment and dose limiting toxicity (DLT) of Bendamustine in patients with lymphoid malignancies undergoing non-myeloablative allogeneic hematopoietic transplantation.

Secondary Objective:

To monitor the risk of graft-versus-host disease (GVHD) and clinical responses.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	02/17/2009

Study Type:	Phase I

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) 18 to 70 years of age .

2) Patients with CD20 + CLL, mantle cell and follicular lymphoma who are eligible for allogeneic transplantation.

3) Patients with relapsed diffuse large B-cell lymphoma may be included if there were not eligible for autologous transplantation.

4) A fully-matched sibling donor.

5) Left ventricular EF > 40% with no uncontrolled arrythmias or symptomatic heart disease.

6) FEV1, FVC and DLCO > 40%.

7) Serum creatinine < 1.6 mg/dL. Serum bilirubin < 3X upper limit of normal.

8) SGPT < 3X upper limit of normal.

9) 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.

10) Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

1) Patient with active CNS disease.

2) Pregnant (Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.

3) Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C.

4) Patients with other malignancies diagnosed within 2 years prior to Study Day-13 (except skin squamous or basal cell carcinoma).

5) Active uncontrolled bacterial, viral or fungal infections.

6) History of Stroke within 6 months.

7) Myocardial infarction within the past 6 months prior to Study Day 1, or has New York Heart Association (NYHA) Class III or IV heart failure or arrythmias, unstable angina, uncontrolled congestive heart failure or arrythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by investigator as not medically relevant.

8) A prior allogeneic transplant.

9) Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

10) Patient has received other investigational drugs within 3 weeks before enrollment.

11) Hypersensitivity to bendamustine.

12) Prior known refractoriness to bendamustine.

Links

Registration Number: NCT00880815
Study Information on Clinical Trials Registry (clinicaltrials.gov)