Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia

NCT00133991 | Completed Phase 2 Results

• 4 other identifiers: J0409P50CA096888P30CA006973NA_00035765
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. 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 combination chemotherapy together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or leukemia.

Conditions

Leukemia; Lymphoma

Keywords

untreated adult acute lymphoblastic leukemia; L3 adult acute lymphoblastic leukemia; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma; stage I adult Burkitt lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma

Outcome Measures

Primary Outcomes (4)

• Overall Response Rate

  Number of participants who have a complete or partial remission (2007 International Working Group criteria).

  Up to 3 months

• Overall Survival

  Percentage of participants alive at 1 year and at 3 years.

  1 year and 3 years

• Event-free Survival

  Percentage of participants alive without relapse at 1 year and 3 years.

  1 year and 3 years

• Percentage of Participants Experiencing Grade 3-5 Toxicity

  Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria).

  Up to 2 years

Secondary Outcomes (1)

• Relapse Pattern

  Up to 6 months

Study Arms (1)

R-CVP + HiCy

EXPERIMENTAL

Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.

Biological: Filgrastim; Biological: Rituximab; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Methotrexate; Drug: Prednisone; Drug: Hydrocortisone; Drug: Vincristine; Drug: Leucovorin

Interventions

Filgrastim BIOLOGICAL

5 mcg/kg/day starting on Day 3 after each R-CVP cycle and on Day 6 after HiCy.

Also known as: Neupogen, G-CSF

R-CVP + HiCy

Rituximab BIOLOGICAL

375 mg/m\^2 on Day 1 and Day 8 of each R-CVP cycle. 375 mg/m\^2 on Day -4 of HiCy and weekly for four weeks after HiCy.

Also known as: Rituxan

R-CVP + HiCy

Cyclophosphamide DRUG

1500 mg/m\^2 on Day 1 of each R-CVP cycle. 50 mg/kg/day on Days -3, -2, -1, and 0 of HiCy.

Also known as: Cytoxan, Cy, CTX, HiCy

R-CVP + HiCy

Cytarabine DRUG

100 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.

Also known as: Ara-C

R-CVP + HiCy

Methotrexate DRUG

3 g/m\^2 on Day 8 of each cycle of R-CVP.

Also known as: MTX

R-CVP + HiCy

Prednisone DRUG

100 mg on Days 1-5 of each cycle of R-CVP.

Also known as: Deltasone

R-CVP + HiCy

Hydrocortisone DRUG

50 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.

R-CVP + HiCy

Vincristine DRUG

1.4 mg/m\^2 on Day 1 of each cycle of R-CVP.

Also known as: Oncovin

R-CVP + HiCy

Leucovorin DRUG

25 mg four times daily after methotrexate administration. Dosing continues until adequate methotrexate levels are reached.

Also known as: Folinic acid

R-CVP + HiCy

Eligibility Criteria

• Age: 30 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Classic, sporadic Burkitt's lymphoma * Burkitt's leukemia (FAB L3 acute lymphoblastic leukemia) * Atypical Burkitt/Burkitt's-like lymphoma or leukemia, defined by the following criteria: * Characteristic morphologic features * High proliferative index AND Ki-67 ≥ 85% * Any stage allowed * Newly diagnosed or untreated disease * Steroids allowed PATIENT CHARACTERISTICS: Age * 30 and over Performance status * Not specified Life expectancy * Not specified Renal * No known irreversible renal dysfunction that would preclude treatment with high-dose cyclophosphamide Cardiovascular * No known significant cardiac dysfunction that would preclude treatment with high-dose cyclophosphamide Other * Not pregnant or nursing * No known HIV positivity * No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for lymphoma * A maximum of 2 prior doses of intrathecal chemotherapy are allowed Endocrine therapy * Not specified Radiotherapy * No prior radiation therapy for lymphoma Surgery * Prior complete or incomplete surgical resection of lymphoma allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Drexel University College of Medicine - Center City Hahnemann Campus

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (1)

• Kasamon YL, Brodsky RA, Borowitz MJ, Ambinder RF, Crilley PA, Cho SY, Tsai HL, Smith BD, Gladstone DE, Carraway HE, Huff CA, Matsui WH, Bolanos-Meade J, Jones RJ, Swinnen LJ. Brief intensive therapy for older adults with newly diagnosed Burkitt or atypical Burkitt lymphoma/leukemia. Leuk Lymphoma. 2013 Mar;54(3):483-90. doi: 10.3109/10428194.2012.715346. Epub 2012 Aug 17.

  PMID: 22835045 RESULT

MeSH Terms

Conditions

Leukemia; Lymphoma; Burkitt Lymphoma

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Rituximab; Cyclophosphamide; Cytarabine; Methotrexate; Prednisone; Hydrocortisone; Vincristine; Leucovorin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Yvette Kasamon, MD
• Organization: Johns Hopkins University

ykasamon@jhmi.edu

Study Officials

• Yvette L. Kasamon, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 24, 2005
• Study Start: July 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2013
• Last Updated: September 17, 2018
• Results First Posted: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)