Conditions: Lymphoma
Keywords: Lymphoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 169
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Temsirolimus (CCI-779) intervention 2: Temsirolimus (CCI-779) intervention 3: Investigator's choice
Intervention descriptions: intervention 1: Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week intervention 2: Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week intervention 3: 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

Protocol document: