Efficacy of Lenalidomide in Combination With Subcutaneous Rituximab + miniCHOP in DLBCL Patients of 80 y/o or+

Browse trials for

• Lymphoma 5,578
• Lymphoma, B-Cell 1,411
• Lymphoma, Large B-Cell, Diffuse 1,390

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 250 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Lead sponsor

The Lymphoma Academic Research Organisation is the lead sponsor of 60 studies on the registry; 12 are open to participants now.

Study arms

• Active comparator
  R-miniCHOP

  All patients will be treated with R-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV: 400 mg/m² Day 1 (D1) DOXORUBICINE IV : 25 mg/m² D1 VINCRISTINE IV : 1 mg Total Dose (TD) D1 PREDNISONE PO : 40 mg/m² D1 to D5 RITUXIMAB SC\* : 1400 mg TD D1 \*The first cycle of rituximab is delivered by IV at the dose of 375 mg/m2

  Drug: Rituximab

• Experimental
  R2-miniCHOP

  All patients will be treated with R2-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV: 400 mg/m² D1 - DOXORUBICINE IV : 25 mg/m² D1 - VINCRISTINE IV : 1 mg TD D1 - PREDNISONE PO : 40 mg/m² D1 to D5 - RITUXIMAB SC\* : 1400 mg TD D1 LENALIDOMIDE PO\*\* :10 mg TD D1 to D14 \*The first cycle of rituximab is delivered by IV at the dose of 375 mg/m2

  Drug: Lenalidomide · Drug: Rituximab

Interventions

• DrugLenalidomide

  Also known as: Revlimid

• DrugRituximab

  Also known as: Mabthera

Primary outcomes

1. The overall survival (OS)

   OS will be measured from the date of randomization to the date of death from any cause. Alive patients will be censored at their last contact.

   Time frame: OS rates at 2 years

Secondary outcomes

1. Progression-Free Survival (PFS)

   PFS is defined as the time from randomization into the study to the first observation of documented disease progression/relapse or death due to any cause. If a subject has not progressed or died, PFS will be censored at the time of last visit with adequate assessment.

   Time frame: PFS rates at 2 years

2. Event-Free Survival (EFS)

   EFS will be measured from the date of randomization to the date of first documented disease progression/relapse (Cheson 1999), initiation of new anti-lymphoma therapy or death from any cause. Patients without documented event at the time of analysis will be censored at their visit with adequate assessment.

   Time frame: EFS rates at 2 years

3. Duration of Response (DoR)

   DoR will be measured from the time of attainment of Complete Response/unconfirmed Complete Response (CR/CRu) or Partial Response (PR) to the date of first documented disease progression/relapse or death from any cause. Patients alive and free of progression will be censored at their last visit with adequate assessment.

   Time frame: DoR rates at 2 years

4. Disease-Free Survival (DFS)

   DFS will be measured from the date of attainment of a complete or unconfirmed complete response (at the end of treatment or at permanent treatment discontinuation evaluation) to the date of first observation of documented disease progression or death due to any cause. Complete Response/unconfirmed Complete Response (CR/CRu) patients who have not progressed or died will be censored at the time of last visit with adequate assessment.

   Time frame: DFS rates at 2 years

5. OS according to GCB/non-GCB phenotype

   OS will be described for the R2-miniCHOP group according to Hans algorithm (GCB/non-GCB phenotype).

   Time frame: OS according to GCB/non-GCB phenotype rates at 2 years

6. Response Rate at the end of treatment

   Disease response evaluation at end of treatment (after 6 cycles) will be used to determine the Response Rate. Response will be assessed at end of treatment (after end of the 6th cycle of treatment or at permanent treatment discontinuation). Assessment of response will be based on the International Workshop to Standardize Response criteria for non-Hodgkin's lymphoma (NHL) (Criteria for evaluation of response in NHL (Cheson, 1999)).

   Time frame: 22 weeks (28 days after the end of the 6, three-weeks interval, cycles of treatment) or within 28 days following permanent treatment discontinuation

7. Simplified Geriatric Scales

   Four geriatric tools will be performed before any chemotherapy administration (Instrumental Activities of Daily Living (IADL), Mini Nutritional Assessment (MNA), G8, and Cumulative Illness Rating Scale for Geriatrics (CIRS-G) scales). Each scale will be analyzed in order to have a picture of the population at baseline. Thereafter, the prognosis impact in OS and PFS of each scale will be evaluated using univariate (Kaplan Meier) and multivariate analyses (Cox model). Safety analyses will also be performed according to each scale in order to evaluate the toxicity predictive power of these scales.

   Time frame: At baseline

8. Health related Quality of Life (HRQOL)

   HRQOL will be assessed by the Quality of Life Questionnaire-C30 and Elderly14 (QLQ-C30 and the QLQ-ELD14) at randomization and at end of treatment. The improvement or not of the QoL will therefore be assessed. The QLQ-ELD14 was developed to supplement the QLQ-C30 for measuring HRQoL in patients aged \>70 years in oncology studies.

   Time frame: At randomization and 22 weeks after Day 1 of Cycle 1 of R-miniCHOP or R2-miniCHOP (28 days after the end of the 6, three-weeks interval, cycles of treatment)

Individual participant data

Plan to share: No