MDACC Study Summary 2006-0697

Study Summary
No. 2006-0697:.......Lymphoma......Jorge Romaguera......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2006-0697

Study Title:	Phase I/II study of bortezomib (VELCADE) plus rituximab-hyperCVAD alternating with bortezomib plus rituximab-high dose methotrexate/cytarabine in patients with untreated aggressive mantle cell lymphoma

Physician

New Patient Referral



Name:	Jorge Romaguera	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	The study patients who start therapy at MDACC will remain in Houston to receive all of their therapy.

Treatment Agents:	Bortezomib Cyclophosphamide Cytarabine Dexamethasone Doxorubicin Methotrexate Rituximab Vincristine	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Four days every 6 weeks. Occasionally additional 5 days every 3 weeks.


Description/ Intervention:	The goal of this clinical research study is to learn if bortezomib (in combination with rituximab plus 2 different intensive chemotherapy regimens) can help to control the disease in patients with mantle cell lymphoma. The safety of these drug combinations will also be studied.

Study Objectives / Outcomes

Phase I:

The primary objective of this study is to:
· Determine the safety and the maximum tolerated dose (MTD) of bortezomib when added to the combination of rituximab, methotrexate, and cytarabine alternating with bortezomib, rituximab-hyperCVAD in patients with untreated aggressive mantle cell lymphoma.

The secondary objectives of this study are to:
· Evaluate overall response rate, complete remission rate, overall survival, and duration of remission.

Phase II:

The primary objective of this phase of the study is to:

Evaluate the time to failure (TTF) rate following therapy with bortezomib plus rituximab-hyperCVAD alternating with bortezomib plus rituximab-high dose methotrexate/cytarabine in patients between 18 and 79 years of age with untreated aggressive mantle cell lymphoma.

The secondary objective of this phase of the study is to:
· Evaluate overall response rate, overall survival, and duration of remission.
· Evaluate toxicity of the combination regimen.
· Correlate outcome with pretreatment markers.

Study Status Information



Study Activation / Registration Date:	04/03/2007

IRB Review and Approval Date:	11/16/2006

Study Type:	Phase I

Recruitment Status:	Open

Projected Accrual:	90

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) Confirmed diagnosis of previously untreated nodular or diffuse mantle cell lymphoma and their blastoid cytologic variant.

2) ECOG Performance status of 0, 1, or 2.

3) Serum bilirubin <1.5mg/dl and serum creatinine < 2.0 mg/dl within 14 dyas before enrollment (unless higher levels are due to lymphoma)

4) Platelet count>100,000/mm^3 and absolute neutrophil count (ANC)>1,000/mm^3 within 14 days before enrollment (unless due to lymphoma).

5) Cardiac ejection fraction >/= 50% by ECHO or MUGA.

6) Age 18 years to 79 years.

7) Patients must be willing to receive transfusions of blood products.

8) Voluntary 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.

9) 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.

10) Male subject agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

1) HIV infection.

2) CNS involvement.

3) Co-morbid medical or psychiatric illnesses that preclude treatment with intense dose chemotherapy.

4) Concurrent or previous malignancy with < 90% probability of survival at 5 years.

5) Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.

6) Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.

7) Patient has hypersensitivity to boron or mannitol.

8) Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.

9) Patient has received other investigational drugs within 14 days before enrollment.

10) Diagnosed or treated for another malignancy ,that has a less than 90% chance of survival at 5 years.

11) Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

Links

Registration Number: NCT00477412
Study Information on Clinical Trials Registry (clinicaltrials.gov)