Expired Study
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Little Rock, Arkansas 72205


Purpose:

This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).


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.)


Study is Available At:


Original ID:

3066K1-305


NCT ID:

NCT00117598


Secondary ID:


Study Acronym:

OPTIMAL


Brief Title:

Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)


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)


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

169


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:May 2005
Completion Date:January 2011
Completion Type:Actual
Primary Completion Date:August 2007
Primary Completion Type:Actual
Verification Date:March 2015
Last Changed Date:March 10, 2015
First Received Date:June 30, 2005
First Results Date:February 2, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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 unti
Safety Issues:False
Description: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) Bon
Outcome Type:Primary Outcome
Measure: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 unti
Safety Issues:False
Description:The period from randomization until disease progression, death or date of last contact.

Study Interventions

Intervention Type:Drug
Name:Temsirolimus (CCI-779)
Description:Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week
Arm Name:A
Intervention Type:Drug
Name:Temsirolimus (CCI-779)
Description:Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week
Arm Name:B
Intervention Type:Drug
Name:Investigator's choice
Description:Any of the following single agent treatments: Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate. Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1
Arm Name:C

Study Arms

Study Arm Type:Experimental
Arm Name:A
Study Arm Type:Experimental
Arm Name:B
Study Arm Type:Active Comparator
Arm Name:C

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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