Trial Outcomes & Findings for Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma (NCT NCT01466881)

Last Updated: 2016-03-10

Results Overview

Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

Up to 1 year after registration

Results posted on

2016-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	MLN8237 Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
Overall Study STARTED	42
Overall Study Eligible and Treated	37
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	MLN8237 Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
Overall Study Ineligible	5
Overall Study Adverse Event	6
Overall Study Progression/relapse	20
Overall Study Death	4
Overall Study Other reason not protocol specified	5

Baseline Characteristics

Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MLN8237 n=37 Participants Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
Age, Continuous	62.0 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year after registration

Population: All eligible patients who started treatment were included in assessing response estimates.

Outcome measures

Outcome measures
Measure	MLN8237 n=37 Participants Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity	Responders Eligible Patients who received protocol treatment and achieved complete or partial response.
Objective Response Rate (Complete Responses (CR) + Partial Responses (PR)) Complete Response	2 participants	—
Objective Response Rate (Complete Responses (CR) + Partial Responses (PR)) Partial Response	7 participants	—
Objective Response Rate (Complete Responses (CR) + Partial Responses (PR)) No response	28 participants	—

SECONDARY outcome

Timeframe: Up to 2 years after registration

Population: Only eligible patients were included in the analysis.

Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Outcome measures
Measure	MLN8237 n=37 Participants Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity	Responders Eligible Patients who received protocol treatment and achieved complete or partial response.
Overall Survival (OS)	8 Months Interval 4.5 to 9.5	—

SECONDARY outcome

Timeframe: Up to 2 years after registration

Population: Only eligible patients were included in the analysis

Measured from date of registration to date of first observation of progressive disease or death due to any cause. Patients last known to be alive and without report of progressive disease are censored at date of last contact. Progressive disease is at least 50% increase in the sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed or ≥ 50% increase in the greatest transverse diameter (GTD) of any node \> 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions over the smallest sum observed. New bone marrow involvement. New lesion \> 1.5 cm in longest axis, or ≥ 50% increase in GTD of any previously involved node with a diameter ≤ 1.0 cm in the short axis such that its longest axis is now \> 1.5 cm. Lymph nodes with long axis is \> 1.5 cm, or if the both the long and short axes are \> 1 cm. PET should be positive if positive PET at baseline.

Outcome measures

Outcome measures
Measure	MLN8237 n=37 Participants Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity	Responders Eligible Patients who received protocol treatment and achieved complete or partial response.
Progression Free Survival (PFS)	3 Months Interval 2.2 to 4.3	—

SECONDARY outcome

Timeframe: Up to 1 year after registration

Population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.

Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Outcome measures

Outcome measures
Measure	MLN8237 n=37 Participants Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity	Responders Eligible Patients who received protocol treatment and achieved complete or partial response.
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Abdominal pain	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Alkaline phosphatase increased	2 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Anemia	12 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Anorexia	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Back pain	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Blood bilirubin increased	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) CD4 lymphocytes decreased	2 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Diarrhea	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Fatigue	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Febrile neutropenia	5 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Fever	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Gastrointestinal disorders - Other, specify	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Hypercalcemia	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Hyperglycemia	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Hypotension	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Infections and infestations - Other, specify	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Leukocytosis	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Lung infection	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Lymph gland infection	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Lymphocyte count decreased	8 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Mucositis oral	4 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Neutrophil count decreased	12 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Pain	2 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Platelet count decreased	9 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Rash maculo-papular	2 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Sepsis	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Skin and subcutaneous tissue disorders - Other	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Skin infection	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Toxic epidermal necrolysis	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) Treatment related secondary malignancy	1 Participants	—
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237) White blood cell decreased	7 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Eligible patients who consented for correlative studies and had Aurora kinase A expression measured.

To explore the association between pre-treatment aurora kinase A expression in tumor biopsies as measured by fluorescence in situ hybridization (FISH) and objective response rate in patients with PTCL treated with MLN8237

Outcome measures

Outcome measures
Measure	MLN8237 n=19 Participants Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity	Responders n=3 Participants Eligible Patients who received protocol treatment and achieved complete or partial response.
Aurora Kinase A Expression	0.121 proportion of positivity Standard Deviation 0.096	0.063 proportion of positivity Standard Deviation 0.060

Adverse Events

MLN8237

Serious events: 19 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MLN8237 n=37 participants at risk Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
Blood and lymphatic system disorders Anemia	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Blood and lymphatic system disorders Febrile neutropenia	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Cardiac disorders Cardiac disorders-Other	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Cardiac disorders Heart failure	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Cardiac disorders Supraventricular tachycardia	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Diarrhea	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Gastrointestinal disorders-Other	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Mucositis oral	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Multi-organ failure	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Lung infection	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Lymph gland infection	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Sepsis	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Skin infection	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Alanine aminotransferase increased	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Blood bilirubin increased	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Neutrophil count decreased	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Platelet count decreased	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypercalcemia	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Flank pain	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Encephalopathy	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Facial nerve disorder	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Seizure	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Acute kidney injury	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Renal and urinary disorders Renal and urinary disorders-Other	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Hypotension	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Thromboembolic event	2.7% 1/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.

Other adverse events

Other adverse events
Measure	MLN8237 n=37 participants at risk Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
Blood and lymphatic system disorders Anemia	62.2% 23/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Blood and lymphatic system disorders Febrile neutropenia	10.8% 4/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Cardiac disorders Sinus tachycardia	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Abdominal pain	10.8% 4/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Constipation	21.6% 8/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Diarrhea	32.4% 12/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Dysphagia	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Mucositis oral	18.9% 7/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Nausea	18.9% 7/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Oral pain	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Rectal hemorrhage	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Gastrointestinal disorders Vomiting	16.2% 6/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Chills	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Edema limbs	21.6% 8/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Fatigue	62.2% 23/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Fever	29.7% 11/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
General disorders Pain	24.3% 9/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Infections and infestations-Other	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Sinusitis	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Skin infection	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Upper respiratory infection	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Infections and infestations Urinary tract infection	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Injury, poisoning and procedural complications Fall	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Alanine aminotransferase increased	13.5% 5/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Alkaline phosphatase increased	21.6% 8/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Aspartate aminotransferase increased	18.9% 7/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Blood bilirubin increased	10.8% 4/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations CD4 lymphocytes decreased	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Creatinine increased	18.9% 7/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Lymphocyte count decreased	37.8% 14/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Neutrophil count decreased	40.5% 15/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Platelet count decreased	51.4% 19/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations Weight loss	10.8% 4/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Investigations White blood cell decreased	40.5% 15/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Anorexia	21.6% 8/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Dehydration	10.8% 4/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypercalcemia	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hyperglycemia	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypernatremia	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hyperuricemia	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypoalbuminemia	24.3% 9/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypocalcemia	18.9% 7/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypoglycemia	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hypokalemia	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Metabolism and nutrition disorders Hyponatremia	24.3% 9/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Back pain	13.5% 5/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Musculoskeletal and connective tissue disorders Pain in extremity	8.1% 3/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Headache	10.8% 4/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Memory impairment	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Peripheral sensory neuropathy	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Nervous system disorders Somnolence	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Psychiatric disorders Anxiety	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Psychiatric disorders Insomnia	8.1% 3/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	13.5% 5/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.1% 3/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Respiratory, thoracic and mediastinal disorders Productive cough	8.1% 3/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Alopecia	24.3% 9/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Pruritus	10.8% 4/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	13.5% 5/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	10.8% 4/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Skin and subcutaneous tissue disorders Skin ulceration	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Hypertension	5.4% 2/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.
Vascular disorders Hypotension	8.1% 3/37 • Up to 1 year after registration Eligible patients who had received any treatment were included. Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0.

Additional Information

Lymphoma Committee Statistician

SWOG Statistical Center

Phone: 206-667-4623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60