At a glance
ClinicalIndex Comparison Record- ✓Mantle cell lymphoma confirmed by histology, immunophenotype, and cyclin D1 analysis
- ✓Received 2 to 7 prior therapies (may include stem cell transplant)
- ✓Prior treatment with alkylating agent, anthracycline, and rituximab
- ✓Primary disease refractory to ≥2 regimens, OR refractory to ≥1 regimen after first relapse, OR refractory/untreated after second or greater relapse, OR refractory to first line and relapsed after second line
- ✕≤6 months from allogeneic stem cell transplant AND on immunosuppressive therapy or have graft-versus-host disease
- ✕Prior investigational therapy within 3 weeks of first dose
- ✕Active CNS metastases (clinical symptoms, cerebral edema, corticosteroid requirement, or progressive growth); treated CNS metastases must be stable >2 weeks prior to Day 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Temsirolimus (CCI-779) and Investigator's choice for Lymphoma. Completed, enrolled 169 participants across 73 sites in 18 countries.
Detailed Summary
This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).
Study Details
Timeline
Interventions
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: 1. Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate. 2. 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 3. 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 4. 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 5. Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response, 6. 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 7. Prednisone 40 (20-60) mg/m2 PO daily or every other day 8. Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day