Bendamustine in combination with ofatumumab as first line treatment for elderly patients with mantle cell lymphoma: a phase II risk-adapted design

Figures & data

Figure 1. Treatment schema.

Table 1. Baseline characteristics.

Characteristic	Ofatumumab (n = 6)	BendOfa (n = 24)	All patients (n = 30)
	No (%)	No (%)	No (%)
Age, median [range] – yr	71 (46, 75)	73 (45, 90)	72 (45, 90)
Male sex	5 (83%)	20 (83%)	25 (83%)
Biologic MIPI category
Low	2 (33%)	1 (4%)	3 (10%)
Intermediate	4 (67%)	6 (25%)	10 (33%)
High risk	0	17 (71%)	17 (57%)
Disease stage
II	2 (33%)	0	2 (7%)
III	0	1 (4%)	1 (3%)
IV	4 (67%)	23 (96%)	27 (90%)
Elevated LDH	0 (0%)	6 (25%)	6 (20%)
Bone marrow involvement	3 (50%)	23 (96%)	26 (87%)
Histologic subtype
Leukemic non-nodal	0	3 (13%)	3 (10%)
Classical	6 (100%)	19 (79%)	25 (83%)
Blastic/blastoid variant	0	2 (8%)	2 (7%)
Ki67
<30%	4 (67%)	13 (54%)	17 (57%)
≥30%	2 (33%)	11 (46%)	13 (43%)
Reason for ineligibility for stem cell transplant
Age ≥ 65 or medically ineligible	4 (67%)	19 (79%)	23 (77%)
Age < 65 and medically ineligible	2 (33%)	2 (8%)	4 (13%)
Age < 65 and patient refusal of HDT/ASCR	0	3 (13%)	3 (10%)

Figure 2. Patient flow chart.

Figure 3. Survival curves.

Table 2. Treatment-related adverse events observed in 5% or more patients and all grade 3 events.

Event	Grade 1	Grade 2	Grade 3	Grade 4	Total, N = 30
Thrombocytopenia	5 (16.7%)	5 (16.7%)	3 (10%)		13 (43%)
Fatigue	12 (40%)	1 (3.3%)			13 (43%)
Infusion-related reaction	1 (3.3%)	11 (36.7%)			12 (30%)
Neutropenia		2 (6.7%)	4 (13.3%)	1 (3.3%)	7 (23%)
Constipation	6 (20%)				6 (20%)
Fever	5 (17%)				5 (17%)
Diarrhea	4 (13%)		1 (3%)		5 (17%)
Hypoalbuminemia	4 (13%)				4 (13%)
Rash maculo-papular	1 (3%)	1 (3%)	2 (7%)		4 (13%)
Nausea	3 (10%)	2 (7%)			5 (17%)
Pruritis	3 (10%)				3 (10%)
Chills	3 (10%)				3 (10%)
Hyperglycemia	1 (13%)	1 (3%)	1 (3%)		3 (10%)
Peripheral sensory neuropathy	3 (10%)				3 (10%)
Skin hyperpigmentation	3 (10%)				3 (10%)
Cough	2 (7%)				2 (7%)
Edema	2 (7%)				2 (7%)
Hypernatremia	2 (7%)				2 (7%)
Elevated ALT/AST	2 (7%)				2 (7%)
Blurred vision		2 (7%)			2 (7%)
Hypertension	1 (3%)		1 (3%)		2 (7%)
Hyponatremia	2 (7%)				2 (7%)
Infections*		1 (3%)	1 (3%)		2 (7%)
Mucositis oral	1 (3%)	1 (3%)			2 (7%)
Sore throat	2 (7%)				2 (7%)

*One patient with Cdiff and one patient with lung infection.