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LymphomaPhase 2NCT00559104

Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

A Phase 2 study testing carmustine, cyclophosphamide and etoposide in people with Lymphoma, run by City of Hope Medical Center 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: Giving chemotherapy and radiation therapy to the entire body before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Read more about this study

Who is it for?
Ages 16 to 59 years
Conditions the study is for
Lymphoma
What is being tested?
carmustine, cyclophosphamide and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
Oct 1998to Jul 2011
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 16 to 59 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • DISEASE CHARACTERISTICS:
  • Biopsy-proven diagnosis of high-grade (small noncleaved cell lymphoma [SNCCL] or immunoblastic lymphoma) or intermediate-grade non-Hodgkin lymphoma (NHL) including mantle cell lymphoma (MCL)
  • SNCCL patients with all of the following factors at presentation of disease:
  • Lactate dehydrogenase (LDH) > 500 IU/L
  • Unresectable bulky mass > 10 cm
  • Stage IV disease with bone marrow involvement
Show all 17Show fewer
  • MCL Patients with stage IV disease or in International Prognostic Index (IPI) high- or high-intermediate-risk group at the time of diagnosis
  • Considered at diagnosis to be high- (3 risk factors) or high-intermediate-risk (2 risk factors) based on an age-adjusted IPI
  • Poor prognostic factors at diagnosis include stage III or IV disease, lactate dehydrogenase (LDH) level above normal, or ECOG performance status (PS) 2-4
  • Patients with primary mediastinal large cell lymphoma with or without sclerosis who at diagnosis had elevated LDH level with bulky mediastinal mass > 10 cm associated with a pleural effusion on chest radiography or computer tomography, or who have persistent mediastinal mass with positive disease by post-treatment gallium GA 67 scan
  • Must have attained a complete response or partial response to first-line standard conventional chemotherapy
  • ECOG PS 0-1 OR Karnofsky PS 80-100%
  • Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min
  • FEV_1 > 65% of predicted measurement or DLCO ≥ 45% of predicted measurement
  • Cardiac ejection fraction > 50% by echocardiogram
  • Bilirubin ≤ 1.5 x normal
  • SGOT or SGPT ≤ 2 x normal

Who cannot join

  • Evidence of lymphoma or < 10% lymphomatous involvement of bone by bilateral bone marrow aspiration and biopsy
  • Abnormal cytogenetic study of bone marrow aspirate sample NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
  • Positive HIV antibody
  • Prior malignancies except for adequately treated basal cell or squamous cell carcinoma of the skin
  • Hepatitis B surface antigen positivity
  • Prior bone marrow transplantation
Show all 9Show fewer
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior bone marrow transplantation

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • City of Hope National Medical Center--Main Campus

    Duarte, California, 91010-3000

  • Good Samaritan Regional Medical Center

    Phoenix, Arizona, 85006

Other trials in United States

About this study

Official title: High-Dose Therapy and Autologous Stem Cell Transplantation During Remission in Poor-Risk Age-Adjusted International Prognostic Index High and High-Intermediate Risk Group Patients With Intermediate Grade and High-Grade Non-Hodgkin's Lymphoma Including Mantle Cell Lymphoma

RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The patient's stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.

PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with or without total-body irradiation followed by a stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma.

Read the detailed description

OBJECTIVES:

  • To evaluate the outcome of patients with poor-risk, age-adjusted International Prognostic Index high- and high-intermediate-risk, intermediate- and high-grade non-Hodgkin lymphoma undergoing high-dose therapy comprising etoposide and cyclophosphamide, either carmustine or total-body irradiation, and autologous stem cell transplantation (ASCT) given as a consolidation therapy.
  • To evaluate the role of high-dose therapy and ASCT during first partial or complete remission (1PR/CR) in patients with poor-risk primary mediastinal large cell lymphoma.
  • To evaluate the role of high-dose therapy and ASCT during first 1PR/CR in patients with advanced-stage mantle cell lymphoma.
  • To evaluate the short-term and long-term toxicities of high-dose therapy and ASCT when performed during 1PR/CR in patients with poor-risk aggressive lymphomas.

OUTLINE: Patients are stratified according to disease (diffuse mixed, diffuse large cell, and immunoblastic lymphoma vs primary mediastinal large cell lymphoma vs small noncleaved cell lymphoma vs stage IV mantle cell lymphoma).

Patients' peripheral blood stem cells (PBSC) are collected after mobilization. A minimum of 2.0 x 10^6 CD34+ cells/kg must be collected. Patients experiencing disease progression during stem cell collection will be removed from study. Patients are assigned to undergo 1 of 2 therapeutic regimens.

  • Regimen 1: Patients undergo total-body irradiation (TBI) on days -8 to -5 and receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo autologous PBSC transplantation on day 0.
  • Regimen 2 (for patients who have received any prior thoracic irradiation or patients who underwent previous irradiation that precludes the use of TBI): Patients receive carmustine IV over 2 hours on days -7 to -5. Patients then receive etoposide and cyclophosphamide and undergo autologous PBSC transplantation as in regimen 1.

Patients with residual bulky disease greater than 5 cm may undergo involved-field radiotherapy before or after transplantation.

Patients are followed at days 7, 14, 21, 100 and 180 after PBSC transplantation, every 6 months for 3 years, and then annually thereafter.

Conditions
Lymphoma
Being tested
carmustine, cyclophosphamide, etoposide, autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation
Keywords
stage III adult diffuse mixed cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV mantle cell lymphoma, stage III mantle cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma
Medical subject headings
Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma

What participants receive

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

  • carmustineDrug

    Also called BCNU

    Unique to the Carmustine in Conditioning arm

  • cyclophosphamideDrug

    Also called Cytoxan, CTX

    Used in Both Arms

  • etoposideDrug

    Also called VP-16

    Used in Both Arms

  • autologous hematopoietic stem cell transplantationProcedure or surgery

    Both arms are given autologous stem cell transplantation

  • peripheral blood stem cell transplantationProcedure or surgery

    Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).

  • total-body irradiationRadiation

    Unique to the Radiation in Conditioning Arm

  • G-CSFDrug

    Also called Granulocyte-colony stimulating factor

    G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.

Study groups in NCT00559104
Study groupRoleWhat they receive
Irradiation in conditioningActive comparatortotal-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematologic stem cell transplantation, peripheral blood stem cell transplantation
Receives: Drug: cyclophosphamide; Drug: etoposide; Procedure: autologous hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: total-body irradiation; Drug: G-CSF
Carmustine in conditioningActive comparatorCarmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor (G-CSF), autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation
Receives: Drug: carmustine; Drug: cyclophosphamide; Drug: etoposide; Procedure: autologous hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Drug: G-CSF

What is being measured

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

  1. Progression

    Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first.

    Below is reported Progression-free Survival: event is relapse or progression, or death.

    Measured: Assessed at date of progression post-transplant

  2. Mortality

    Event will be recorded if it occurs any time from the date of transplant until the end-of-study date, or the date of last contact, whichever comes first.

    Measured: Assessed at date of death post-transplant

Secondary outcomes (1)

  1. Short-term and Long-term Treatment-related Toxicities

    Patient may be assessed for toxicities any time after transplant, up to death, last contact date, or end-of-study date.

    Measured: Any time after transplant

Timeline

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

  1. First posted16 Nov 2007 (estimated)
  2. Study startOct 1998
  3. Primary completionJul 2011
  4. Study completionJul 2011

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00559104
Sponsor's protocol ID
97133
Other IDs
P30CA033572, CHNMC-97133, CDR0000573523
Status last verified
Jul 2015
First submitted
15 Nov 2007
Last updated
11 Aug 2015
Data monitoring committee
Yes

Publications

  • Nademanee A, Molina A, Dagis A, Snyder DS, O'Donnell MR, Parker P, Stein A, Smith E, Planas I, Kashyap A, Spielberger R, Fung H, Krishnan A, Bhatia R, Wong KK, Somlo G, Margolin K, Chow W, Sniecinski I, Vora N, Slovak M, Niland JC, Forman SJ. Autologous stem-cell transplantation for poor-risk and relapsed intermediate- and high-grade non-Hodgkin's lymphoma. Clin Lymphoma. 2000 Jun;1(1):46-54. doi: 10.3816/clm.2000.n.004.

    PubMed 11707813

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carmustine, cyclophosphamide and etoposide in people with Lymphoma, run by City of Hope Medical Center 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?

The sponsor lists 17 inclusion and 9 exclusion criteria. 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 11 Aug 2015. 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 11 Aug 2015). 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?

Progression (time frame: Assessed at date of progression post-transplant). The study lists 2 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 NCT00559104, 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 11 Aug 2015.

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