Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL) (OPTIMAL)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00117598
First received: June 30, 2005
Last updated: February 2, 2012
Last verified: February 2012
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Purpose
This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Temsirolimus (CCI-779) Drug: Investigator's choice |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Randomized, Phase 3 Trial Of Intravenous Temsirolimus (CCI-779) At Two Dose Levels Compared To Investigator's Choice Therapy In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Progression-Free Survival (PFS) [ Time Frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5) ] [ Designated as safety issue: No ]The period from randomization until disease progression, death or date of last contact.
Secondary Outcome Measures:
- Percentage of Participants With Objective Response [ Time Frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5) ] [ Designated as safety issue: No ]Assessment of complete or partial response (CR, PR) or uncomplete response (CRu) using Response Evaluation Criteria in Solid Tumors. CR: 1) No disease evident. 2) Lymph node, nodal mass regressed to normal size. 3) Previously enlarged organ ↓ size. 4) Bone marrow clear on repeat aspirate, biopsy. CRu: CR 1 and 3, at least 1 of following: Lymph node regressed >75%. Bone marrow ↑ number or aggregate size, no cytologic/architectural atypia. PR: ≥50% ↓ index lesion, no size ↑ in other nodes, liver, spleen. Splenic and hepatic nodule regressed ≥50%. No new disease.
| Enrollment: | 169 |
| Study Start Date: | May 2005 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week
|
| Experimental: B |
Drug: Temsirolimus (CCI-779)
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week
|
| Active Comparator: C |
Drug: Investigator's choice
Any of the following single agent treatments:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Mantle cell lymphoma (MCL) confirmed with histology, immunophenotype, and cyclin D1 analysis
- Received 2 to 7 prior therapies which may include hematopoietic stem cell transplant (i.e. induction + consolidation + maintenance)
- Prior treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and status that is at least one of the following:
- Primary disease refractory to at least 2 regimens;
- Refractory to at least 1 regimen after first relapse;
- Refractory or untreated after second or greater relapse;
- Refractory to first line and relapsed after second line. Chemotherapy combinations may include, but are not limited to: CHOP (Cyclophosphamide, doxorubicin, vincristine, prednisone), R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, prednisone), FCM (Fludarabine, cyclophosphamide, mitoxantrone), R-FCM (Rituximab,Fludarabine, cyclophosphamide, mitoxantrone), ICE(Ifosfamide, carboplatin, etoposide), DHAP (Dexamethasone, cisplatin, cytarabine) and hyper-CVAD (Cyclophosphamide, doxorubicin, vincristine, dexamethasone).
Exclusion Criteria:
- Subjects who are less than or equal to six month from allogeneic hematopoietic stem cell transplant and who are on immunosuppressive therapy or have evidence of graft versus host disease
- Prior investigational therapy within 3 weeks of first dose. Investigational therapy is defined as treatment that is not approved for any indication.
- Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth. (Treated CNS metastases must be stable for > 2 weeks prior to Day 1.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117598
Show 72 Study Locations
Show 72 Study LocationsSponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00117598 History of Changes |
| Obsolete Identifiers: | NCT00326547 |
| Other Study ID Numbers: | 3066K1-305 |
| Study First Received: | June 30, 2005 |
| Results First Received: | February 2, 2012 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Sirolimus Everolimus |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 22, 2013