Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Fludarabine

Fludarabine phosphate

Ofatumumab

Ofatumumab IV, initial dose 300 mg, followed 1 week later with 2000 mg once weekly for 7 weeks, followed 4 weeks later by one infusion of 2000 mg every 4 weeks for 4 infusions, for a total of 12 infusions over 24 weeks. After 24 weeks of ofatumumab treatment, patients who have achieved at least stable disease or better, and whom the investigator would deem appropriate for the therapy to continue, would undergo a second randomisation (2:1) to either 1) an additional ofatumumab dose regimen of 2000 mg once every 4 weeks for up to an additional 24 weeks, or 2) no further therapy (i.e. observation only).

Non-ofatumumab containing regimen as per physicians' choice for up to 6 months. Permitted therapies include treatments approved for CLL, and well established standards of care for CLL.

Physicians' Choice

Novartis Pharmaceuticals

The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.

Patients with CLL that is refractory to fludarabine have few treatment options and a poor prognosis. There is a continued need for new therapies for these CLL patients, as demonstrated by the limited responses and substantial toxicities with existing therapies. This is supported by the lack of a consensus around standard of care treatment for CLL patients with bulky fludarabine-refractory disease. The objective of this study was to confirm the response rate and disease control in the refractory setting through a controlled trial comparing ofatumumab with the physicians' choice of therapy in fludarabine-refractory, bulky lymphadenopathy patients. After 24 weeks of treatment with ofatumumab, patients were further randomized to either extended ofatumumab treatment or observation. Patients on the physicians' choice arm had the option of receiving ofatumumab if they experience progressive disease.

Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia

An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.

ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). ORR was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils \>1500 per microliter(µL), platelets(PL) \>100,000/µL, hemoglobin(Hb) \>11 grams/deciliter(g/dL), lymphocytes(LC) \<4000/µL, bone marrow(BM) sample must be normocellular for age, \<30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: \>=50% decrease in LC, reduction in Ly (i.e., \>=50% decrease in lymph node size or no increase or new lymph nodes), \>=50% decrease in the size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline(BL), Hb \>11 g/dL or 50% improvement over BL, neutrophils\>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.

ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). Overall response was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils \>1500 per microliter(µL), platelets(PL) \>100,000/µL, hemoglobin(Hb) \>11 grams/deciliter(g/dL), lymphocytes(LC) \<4000/µL, bone marrow(BM) sample must be normocellular for age, \<30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: \>=50% decrease in LC, reduction in Ly (i.e., \>=50% decrease in lymph node size or no increase or new lymph nodes), \>=50% decrease in the size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline(BL), Hb \>11 g/dL or 50% improvement over BL, neutrophils\>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.

Overall survival (OS) is defined as the time from randomization to death due to any cause. Kaplan-Meier plots were used to estimate the reported median OS time.

Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.

Time to next therapy is defined as the time from randomization until the start of the next line of treatment.

Time to response is defined as the time from randomization to the first response (Complete Remission\[CR\], Complete Remission with incomplete bone marrow recovery\[CRi\], partial response\[PR\], or nodular PR\[nPR\]). CR(all the criteria at least 2 months after last treatment): no lymphadenopathy(Ly) \> 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils \>1500 per microliter(µL), platelets(PL) \>100,000/µL, hemoglobin(Hb) \>11 grams/deciliter(g/dL), lymphocytes(LC) \<4000/µL, bone marrow(BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: \>=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline(BL), Hb \>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders.

DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (\>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect.

AEs of special interest included cytopenias (neutropenia \[decreased neutrophil count\], anaemia \[decreased hemoglobin\], and thrombocytopenia \[decreased platelet count\]), autoimmune haematologic complications (autoimmune haemolytic anaemia and haemolytic anaemia), infusion reactions, infections, mucocutaneous reactions, Tumour Lysis Syndrome (TLS), cardiovascular events, and small bowel obstruction.

Immunoglobulins or antibodies are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Immunoglobulin testing was performed at Screening (SCR), Cycle 3 Week 4 (C3W4), Cycle 7 Week 4 (C3W4) ,Cycle 9 Week 4 (C3W4), 6 Month Follow-up Visit (6M FU), 9 Month Follow-up (9M FU), 12 Month Follow-up (12M FU), 18 Month Follow-up (18M FU), 24 Month Follow-up (24M FU), 30 Month Follow-up (30M FU), 36 Month Follow-up (36M FU), 42 Month Follow-up (42M FU). A cycle is defined as the time between one round of treatment until the start of the next round.

The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (Neg) results.

The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects (\[TSE\], 4 items), disease symptoms (disease effects scale \[DES\], 4 items), and infection (4 items) - and single item scales (social activities \[Social Problems (SP) Scale\] and future health worries\[Future Health (FH) Scale\].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Week (W) 12 (W4 of Cycle\[C\] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during Follow-up which was every month for Months (M) 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD.

The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. A score of 3 or less indicates improvement from Baseline. HCQ was assessed at Screening; Week (W) 12 (W4 of Cycle\[C\] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during follow-up which was every month for Months 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD..

Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.

Any Ofatumumab

Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.

Ofatumumab Extended

Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.

Ofatumumab Observation

Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization. Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.

Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive s(ingleagent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU

Physicians Choice

Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anticancer therapy information was collected in the SFU.

Ofatumumab Salvage

Any Ofatumumab (OFA)

Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.

Physician's Choice (PC)

Ofatumumab Extended (OFA Ext)

Ofatumumab Observation (OFA Observ.)

Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.

Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.

OFA First Randomization Only (OFA FRO)

Total

The Intent-to-Treat (ITT) population included subjects who were randomized.

Age, Continuous

Sex: Female, Male

Hispanic or Latino

Not Hispanic or Latino

Race/Ethnicity, Customized

The Intent-to-Treat (ITT) population included subjects who were randomized. Note: The Total participants in the Baseline Characteristics Table \& in most of the Efficacy results Tables should be either Any OFA + Physician's Choice or OFA extended + OFA observation + OFA + Physician's Choice instead of the automatic calculated Total number indicated

Clinical Disclosure Office

These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.

Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.

Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)

Progression-free Survival (PFS) as Assessed by Investigator

Stable Disease

Progressive Disease

Not Evaluable

Missing

ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.

Overall Response Rate (ORR) as Assessed by the IRC

Overall Response Rate (ORR) as Assessed by the Investigator

ITT population. Only those participants with data available were analyzed, participants who had not died were censored at the date of last contact.

Overall Survival

ITT population. Only those participants with data available were analyzed.

Time to Progression as Assessed by IRC

Time to Next Anti-cancer Therapy by Investigator

ITT population. Only responders (CR, CRi, PR, nPR) were included in the analysis. Response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.

Time to Response as Assessed by the IRC

ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.

Duration of Response as Assessed by the IRC

Any AE

Any SAE

Any FSAE

Deaths

The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.

OFA Salvage

Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.

Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths

Any AE of decreased neutrophil count

Any AE of decreased hemoglobin

Any AE of decreased platelet count

Any AE of autoimmune haemolytic anaemia

Any AE of haemolytic anaemia

Any infusion related AE

Any AE of Infection

Any AE of mucocutaneous reaction

Any AE of TLS

Any AE of cardiovascular events

Any AE of small bowel obstruction

Number of Participants With Any Adverse Event (AE) of Special Interest

IgA, SCR

IgG, SCR

IgM, SCR

IgA, C3W4

IgG, C3W4

IgM, C3W4

IgA, C7W4

IgG, C7W4

IgM, C7W4

IgA, C9W4

IgG, C9W4

IgM, C9W4

IgA, 6M FU

IgG, 6M FU

IgM, 6M FU

IgA, 9M FU

IgG, 9M FU

IgM, 9M FU

IgA, 12M FU

IgG, 12M FU

IgM, 12M FU

IgA, 18M FU

IgG, 18M FU

IgM, 18M FU

IgA, 24M FU

IgG, 24M FU

IgM, 24M FU

IgA, 30M FU

IgG, 30M FU

IgM, 30M FU

IgA, 36M FU

IgG, 36M FU

IgM, 36M FU

IgA, 42M FU

IgG, 42M FU

IgM, 42M FU

Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time

CNF Pos

Neg and no OFA concentration <200 ug/mL

Neg and at least one OFA concentration <200 ug/mL

Safety Population. Only those participants with post-OFA treatment HAHA results were analyzed.

Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy

DES, C3W4

DES, C6W4

DES, C9W4

DES, C12W4

DES, 3MFU

DES, 5MFU

DES, 6MFU

DES, 7MFU

DES, 9MFU

DES, 11MFU

DES, 12MFU

DES, 15MFU

DES, 18MFU

DES, 21MFU

DES, 24MFU

DES, 27MFU

DES, 30MFU

Fatigue Scale, C3W4

Fatigue Scale, C6W4

Fatigue Scale, C9W4

Fatigue Scale, C12W4

Fatigue Scale, 3MFU

Fatigue Scale, 5MFU

Fatigue Scale, 6MFU

Fatigue Scale, 7MFU

Fatigue Scale, 9MFU

Fatigue Scale, 11MFU

Fatigue Scale,12MFU

Fatigue Scale, 15MFU

Fatigue Scale, 18MFU

Fatigue Scale, 21MFU

Fatigue Scale, 24MFU

Fatigue Scale, 27MFU

Fatigue Scale, 30MFU

Future Health Scale, C3W4

Future Health Scale, C6W4

Future Health Scale, C9W4

Future Health Scale, C12W4

Future Health Scale, 3MFU

Future Health Scale, 5MFU

Future Health Scale, 6MFU

Future Health Scale, 7MFU

Future Health Scale, 9MFU

Future Health Scale, 11MFU

Future Health Scale, 12MFU

Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia	NCT01313689	Leukaemia	Ofatumumab Physicians' Cho...	18 Years -	Novartis
Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia	NCT01313689	Leukaemia	Ofatumumab Physicians' Cho...	18 Years -	Novartis
Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia	NCT01313689	Leukaemia	Ofatumumab Physicians' Cho...	18 Years -	Novartis

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