Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT01281917 |
Recruitment Status :
Completed
First Posted : January 24, 2011
Results First Posted : August 21, 2017
Last Update Posted : August 21, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Hodgkins Lymphoma | Drug: Velcade Drug: Temsirolimus | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Velcade and Temsirolimus for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | June 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Velcade plus Temsirolimus
Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. |
Drug: Velcade
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Other Name: bortezomib, PS-341 Drug: Temsirolimus Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Other Name: Torisel |
- Overall Response Rate [ Time Frame: Up to 60 months ]The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Progression Free Survival [ Time Frame: Up to 60 months ]The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).
- Safety of This Regimen [ Time Frame: Up to 36 months ]Safety of the regimen will be measured by frequency and severity of adverse events.
- Complete Response Rate [ Time Frame: Up to 60 months ]The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.
- Tolerability of the Regimen [ Time Frame: Up to 36 months ]Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.
- Duration of Response [ Time Frame: Up to 60 months ]Duration of Response is how long a response to therapy is held before a subject has progressive disease.
- Overall Survival [ Time Frame: Up to 60 months ]Length of time from enrollment until death.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Relapsed or refractory B-cell non-Hodgkin lymphoma which includes: diffuse large B-cell lymphoma; primary mediastinal large B-cell lymphoma; follicular lymphoma (grade 1, 2 or 3); mantle cell lymphoma; small lymphocytic lymphoma; marginal zone lymphoma; lymphoplasmacytic lymphoma; B-cell lymphoblastic lymphoma; or Burkitt lymphoma. "Grey-zone" lymphomas must be approved by the Wisconsin Oncology Network (WON) Study Chair or Principal Investigator prior to enrollment.
- At least one measurable tumor mass (>1.5 cm in the long axis and > 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation.
- Documented relapse or progression following prior antineoplastic therapy.
- No clinical or documented radiographic evidence of central nervous system lymphoma.
- Eastern Cooperative Oncology Group [ECOG] performance status of 0-2.
- The following clinical laboratory values within 14 days prior to enrollment:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells / L
- Platelets ≥ 100 x 109 cells / L
- Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 3X the upper limit of normal (ULN)
- Total bilirubin ≤ 2X the upper limit of normal (ULN).
- Calculated creatinine clearance ≥40 mL/min (using the Cockcroft-Gault equation).
- Female subjects must be either post-menopausal for at least 1 year or surgically sterilized, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of Velcade, or agree to completely abstain from heterosexual intercourse.
- Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
Exclusions:
- Antineoplastic, experimental, or radiation therapy within 14 days prior to enrollment, or 21 days prior to Day 1 of Cycle 1.
- Radioimmunoconjugates within 10 weeks of Day 1 of Cycle 1.
- Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or any prior history of allogeneic stem cell transplant.
- Platelet transfusion within 7 days of Day 1 of Cycle 1.
- Ongoing therapy with glucocorticoids. Prednisone ≤15 mg per day or its equivalent is allowed.
- Patient has Grade 2 or greater peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patient has hypersensitivity to Velcade, boron or mannitol.
- Female subjects that are pregnant or breast-feeding.
- Serious medical or psychiatric illness that is likely to interfere with participation
- Diagnosed or treated for another malignancy within 2 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.
- Prior therapy with both Velcade and temsirolimus. Patients who have previously been treated with either Velcade or temsirolimus (but not both) are eligible.
- Radiation therapy within 3 weeks before randomization.
- Patients must not be taking the following strong CyP3A inducers at study entry: phenytoin, phenobarbital, rifampin, carbamazepin, rifabutin, rifampicin, a one week washout period is required.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281917
United States, South Dakota | |
Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute | |
Rapid City, South Dakota, United States, 57701 | |
United States, Wisconsin | |
Aurora Baycare Medical Center-GreenBay | |
Green Bay, Wisconsin, United States, 54143 | |
St Vincent Regional Cancer Center CCOP | |
Green Bay, Wisconsin, United States, 54301 | |
Bellin Memorial Hospital, Inc | |
Green Bay, Wisconsin, United States, 54313 | |
Gunderson Lutheran Health System | |
La Crosse, Wisconsin, United States, 54601 | |
UW Health Oncology- 1 S Park | |
Madison, Wisconsin, United States, 53715 | |
University Of Wisconsin Cancer Center | |
Madison, Wisconsin, United States, 53792 | |
Aurora BayCare Medical Center | |
Marinette, Wisconsin, United States | |
Marshfield Clinic | |
Marshfield, Wisconsin, United States, 54449 | |
Columbia St Mary's, Inc | |
Milwaukee, Wisconsin, United States, 53211 | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
Aurora Sheboygan Memorial Medical Center | |
Sheboygan, Wisconsin, United States, 53081 | |
Aurora Medical Center in Summit | |
Summit, Wisconsin, United States, 53066 | |
Aurora Medical Center in Two Rivers | |
Two Rivers, Wisconsin, United States, 54241 | |
Waukesha Memorial Hospital | |
Waukesha, Wisconsin, United States, 53188 | |
Aspirus Wausau Hospital | |
Wausau, Wisconsin, United States, 54401 | |
Aurora Health Care Metro, Inc. | |
Wauwatosa, Wisconsin, United States, 53226 | |
UW Cancer Center-Riverview | |
Wisconsin Rapids, Wisconsin, United States, 54494 |
Principal Investigator: | Brad S Kahl, MD | Universtity of Wisconsin- Madison | |
Study Chair: | Timothy S Fenske, MD | Medical College of Wisconsin |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT01281917 History of Changes |
Other Study ID Numbers: |
HO10407 H-2010-0393 ( Other Identifier: IRB ) |
First Posted: | January 24, 2011 Key Record Dates |
Results First Posted: | August 21, 2017 |
Last Update Posted: | August 21, 2017 |
Last Verified: | July 2017 |
velcade temsirolimus non-hodgkins lymphoma |
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Sirolimus Bortezomib |
Everolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |