Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Temsirolimus (CCI-779); Temsirolimus (CCI-779); Investigator's choice
Intervention description: Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week; Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week; 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 (400-1200) mg/m2 IV every 21 to 28 days
Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,
Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days
Prednisone 40 (20-60) mg/m2 PO daily or every other day
Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma

Summary:

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

Eligibility 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.)