Phase 2 N=25 Treatment

Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00392990 ↗

Enrolled (actual)

Serious AEs

88.0%

Results posted

Oct 2019

Primary outcome: Primary: Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen — 100; 100; 100; 100 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Regimen A (Drug); Regimen B (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen	100; 100; 100; 100	—
SECONDARY Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen	81; 100	—
SECONDARY Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate)	13; 3; 1; 0; 5; 2	—
SECONDARY Progression Free Survival (PFS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen	76; 100	—

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome and rituximab together with combination chemotherapy works in treating patients with newly diagnosed Burkitt's lymphoma or Burkitt-like lymphoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed Burkitt's or Burkitt-like non-Hodgkin's lymphoma meeting 1 of the following risk criteria:
Low-risk disease meeting all of the following criteria:
Normal lactate dehydrogenase level
ECOG performance status 0-1
Ann Arbor stage I or II
No tumor mass over 10 cm in greatest diameter
High-risk disease, defined as disease not meeting low-risk criteria
Newly diagnosed disease

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Hemoglobin ≥ 8.0 g/dL
Absolute neutrophil count ≥ 500/mm³
Platelet count ≥ 100, 000/mm³ (50,000/mm³ if bone marrow involvement is documented)
AST and ALT ≤ 3 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 3 times ULN
Bilirubin ≤ 1.5 times ULN (3 times ULN if liver metastases are present)
Creatinine clearance > 50 mL/min
Creatinine ≤ 2.0 mg/dL
LVEF ≥ 45% by MUGA scan or echocardiogram
No New York Heart Association class II-IV heart failure
No clinically significant pericardial disease
No myocardial infarction within the past 6 months
No uncontrolled angina
No severe uncontrolled ventricular arrhythmias
No ECG evidence of acute ischemia or active conduction system abnormalities
Investigator must document any baseline ECG abnormality as not medically relevant
No other malignancy within the past year except for basal cell carcinoma of the skin or in situ carcinoma of the cervix
No other serious medical or psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Prior treatment with 1 course of any combination of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and/or prednisone* (CHOP)-like therapy allowed, provided the following doses are not exceeded:
Rituximab 750 mg/m²
Cyclophosphamide 1,000 mg/m²
Doxorubicin hydrochloride 50 mg/m²
Vincristine 2 mg/m²
No other investigational drugs within the past 14 days
No other concurrent systemic, cytotoxic, investigational, or chemotherapy agents NOTE: *No maximum dose restriction on steroids

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00392990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.