NCT00039130|CompletedPhase 2Results

Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia

Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

CALGB-10002U10CA031946CDR0000069354

Study Type

interventional

Target

105

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedMay 2002

CompletionOct 2014

Brief Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

105

participants targeted

Target at P75+ for phase_2 leukemia

Timeline

Completed

Started May 2002

Longer than P75 for phase_2 leukemia

Geographic Reach

1 country

31 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.4 years study duration

Study Start

First participant enrolled

May 1, 2002

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2002

Completed

8 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed

4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed

21 days until next milestone

Results Posted

Study results publicly available

October 22, 2014

Completed

Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

8.3 years

First QC Date

June 6, 2002

Results QC Date

October 16, 2014

Last Update Submit

August 16, 2023

Conditions

Leukemia Lymphoma

Keywords

untreated adult acute lymphoblastic leukemiaL3 adult acute lymphoblastic leukemiastage I adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomacontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult Burkitt lymphoma

Outcome Measures

Primary Outcomes (1)

Complete Response Rate
Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.
6 months

Secondary Outcomes (2)

2 Year Event Free Survival
2 years
2 Year Overall Survival
2 years

Study Arms (1)

Rituximab with High Intensity Chemotherapy

EXPERIMENTAL

Cycle1: Cyclophosphamide 100 mg/m\^2/day (d) IV (d 1-5), Prednisone 60 mg/m\^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14) Cycle 2, 4 \& 6 (21 day): Ifosfamide 800 mg/m\^2/d (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 25 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m\^2/d over 2 h (d 4-5), Etoposide 80 mg/m\^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m\^2 d 8 cycle 2 only, 375 mg/m\^2/d (d 10, 12 cycle 2, d 8 cycle 4 \& 6) Cycle 3, 5 \& 7 (21 day): Cyclophosphamide 200 mg/m\^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m\^2/d (d1-5), Methotrexate 150 mg/m\^2 load, then 1.35 g/m\^2 over 23.5 h (d 1), Leucovorin 50 mg/m\^2 36 h after methotrexate (d 2) then 10 mg/m\^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m\^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m\^2/d (d 8)

Biological: filgrastimBiological: rituximabDrug: cyclophosphamideDrug: cytarabineDrug: dexamethasoneDrug: doxorubicin hydrochlorideDrug: etoposideDrug: ifosfamideDrug: leucovorin calciumDrug: methotrexateDrug: prednisoneDrug: vincristine sulfateDrug: Allopurinol