A phase II study to evaluate lenalidomide in combination with metronomic-dose cyclophosphamide in patients with heavily pretreated classical Hodgkin lymphoma

Figures & data

Table I. Lenalidomide dose levels.

Level	mg/day every 28 days	Patients in cycle 1 (n)	Patients in cycle 2 (n)	Patients in cycle 3 (n)	Patients in last cycle (n)
2	25 mg for 28 days	0	0	7	6
1	20 mg for 28 days	0	9	2	1
0	20 mg for 21 days	16	7	7	5
−1	15 mg for 21 days	0	0	0	2
−2	10 mg for 21 days	0	0	0	2
−3	5 mg for 21 days	0	0	0	0

Table II. Patient characteristics.

Sex	Male	10 (62%)	Age (years)	Median	34
	Female	6 (38%)		Range	18–77
Initial stage	I	1 (6%)	Stage at inclusion	I	0 (0%)
	II	8 (50%)		II	2 (12.5%)
	III	5 (31%)		III	2 (12.5%)
	IV	2 (13%)		IV	12 (75%)
Primary refractory	Yes	10 (62%)	Refractory to last therapy	Yes	11 (69%)
	No	6 (38%)		No	5 (31%)
Number of previous lines	Median	5	Number of lines pre ASCT	Median	3
	Range	2–6		Range	2–4
Previous ASCT	Yes	12 (75%)	Previous allotransplant	Yes	5 (31%)
	No	4 (25%)		No	11 (69%)
TTP after ASCT (months)	Median	5	Time from dx to inclusion (months)	Median	58
	Range	3–23		Range	13–128
Performance status	ECOG 0	6 (38%)	Hemoglobin (gr/dl)	> 12	6 (38%)
	ECOG 1	9 (56%)		10.5–12	2 (12%)
	ECOG 2	1 (6%)		< 10.5	8 (50%)
B symptoms	Yes	5 (31%)	Bulky disease	Yes	6 (38%)
	No	11 (69%)		No	10 (62%)
Extranodal disease	Yes	12 (75%)	Albumin (gr/dl)	> 40	10 (62%)
	No	4 (25%)		< 40	6 (38%)
Leucocytes	> 15000/μL	4 (25%)	Lymphocytes	> 600/μL	11 (69%)
	< 15000/μL	12 (75%)		< 600/μL	5 (31%)

ASCT, autologous stem cell transplantation; dx, diagnosis; ECOG, Eastern Cooperative Oncology Group performance status scale; TTP, time to progression.

Figure 1. Progression-free and overall survival.