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LeukemiaPhase 2NCT00133991

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

A Phase 2 study testing Filgrastim, Rituximab and Cyclophosphamide in people with Leukemia and Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 120 years
Conditions the study is for
Leukemia, Lymphoma
What is being tested?
Filgrastim, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
2 sitesUnited States
Study dates
Jul 2005to Aug 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Drexel University College of Medicine - Center City Hahnemann Campus

    Philadelphia, Pennsylvania, 19102

Other trials in United States

About this study

Official title: Phase II Study of Intensified CVP, Rituximab, and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like Lymphoma

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the overall response rate, 1-year event-free survival, and overall survival of adult patients with newly diagnosed Burkitt or atypical Burkitt lymphoma or leukemia treated with dose-intensified induction therapy comprising cyclophosphamide, vincristine, prednisone, and rituximab followed by consolidation therapy comprising rituximab and high-dose cyclophosphamide.
  • Determine the grade 3 or higher non-hematologic toxic effects and overall tolerability of this regimen in these patients.

Secondary

  • Determine the 3-year event-free survival and overall survival of patients treated with this regimen.
  • Determine the general patterns of CNS and systemic relapse in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Dose-intensified CVP induction therapy: Patients receive cyclophosphamide IV and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5 and rituximab IV on days 1 and 8, and high-dose methotrexate IV with leucovorin calcium IV rescue on day 8. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 3 and continuing until blood counts recover. Treatment repeats approximately every 14 days for 2 courses.
  • CNS therapy: Patients receive cytarabine intrathecally (IT) with or without hydrocortisone IT on days 1, 4, and 11 of each induction therapy course. Patients with evidence of CNS involvement by lymphoma continue to receive cytarabine IT twice weekly during any induction therapy treatment delay. Patients who demonstrate CSF clearance receive cytarabine IT once weekly for 4 doses and then once every other week for 4 doses during consolidation therapy. Patients with disease progression during induction therapy or persistent CNS involvement by lymphoma are removed from the study. All other patients proceed to consolidation therapy.
  • Consolidation therapy: Patients receive rituximab IV on day -4 and high-dose cyclophosphamide IV on days -3, -2, -1, and 0. Patients receive G-CSF SC once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6. Patients then receive rituximab IV once weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

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
Medical subject headings
Leukemia, Lymphoma, Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FilgrastimBiological

    Also called Neupogen, G-CSF

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

  • RituximabBiological

    Also called Rituxan

    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.

  • CyclophosphamideDrug

    Also called Cytoxan, Cy, CTX, HiCy

    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.

  • CytarabineDrug

    Also called Ara-C

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

  • MethotrexateDrug

    Also called MTX

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

  • PrednisoneDrug

    Also called Deltasone

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

  • HydrocortisoneDrug

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

  • VincristineDrug

    Also called Oncovin

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

  • LeucovorinDrug

    Also called Folinic acid

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

Study groups in NCT00133991
Study groupRoleWhat they receive
R-CVP + HiCyExperimentalProtocol 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.
Receives: Biological: Filgrastim; Biological: Rituximab; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Methotrexate; Drug: Prednisone; Drug: Hydrocortisone; Drug: Vincristine; Drug: Leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

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

    Measured: Up to 3 months

  2. Overall Survival

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

    Measured: 1 year and 3 years

  3. Event-free Survival

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

    Measured: 1 year and 3 years

  4. 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).

    Measured: Up to 2 years

Secondary outcomes (1)

  1. Relapse Pattern

    Percentage of participants experiencing central nervous system (CNS) and systemic relapse.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionAug 2011
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00133991
Sponsor's protocol ID
J0409
Other IDs
P50CA096888, P30CA006973, NA_00035765
Status last verified
Sep 2018
First submitted
22 Aug 2005
Last updated
17 Sep 2018
Individual data sharing
No

Publications

  • 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.

    PubMed 22835045

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Filgrastim, Rituximab and Cyclophosphamide in people with Leukemia and Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Up to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00133991, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.

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