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AzTrials

LeukemiaPhase 1NCT00012207

Biological Therapy After Chemotherapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase 1 study testing aldesleukin, therapeutic autologous lymphocytes and cyclophosphamide in people with Leukemia and Lymphoma, run by Fred Hutchinson Cancer Center at 3 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: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more cancer cells. Read more about this study

Who is it for?
Any age
Conditions the study is for
Leukemia, Lymphoma
What is being tested?
aldesleukin, therapeutic autologous lymphocytes and cyclophosphamide
Type of treatment
Surgery or procedure
How many people
12 participants
Where
3 sitesUnited States
Study dates
Sep 2000to Jul 2010
Phase
Phase 1
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Immunohistopathologically documented relapsed or refractory CD20+ indolent lymphomas or mantle cell lymphoma
  • Indolent B-cell lymphomas including any of the following subtypes:
  • Follicular lymphoma (grade I, II, or III)
  • Small lymphocytic lymphoma or chronic lymphocytic leukemia
  • Marginal zone lymphoma (splenic, nodal, and extra-nodal)
  • Lymphoplasmacytoid lymphoma
  • Ineligible for or unwilling to participate in other FHCRC/UWMC protocols
  • Serological evidence of prior exposure to Epstein-Barr virus
  • Must agree to undergo peripheral blood drawing, bone marrow biopsy, lymph node biopsy, and nuclear medicine imaging
  • Must agree to cytoreductive chemotherapy if necessary to reduce lymph nodes to < 5 cm in diameter or circulating B lymphocyte counts to < 5,000/mm^3
  • No pulmonary involvement
  • No CNS involvement

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Not specified

Life expectancy:

  • At least 90 days

Hematopoietic:

  • Not specified

Hepatic:

  • No active hepatitis B infection

Renal:

  • Not specified

Other:

  • No HIV positivity
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No history of hypersensitivity reactions to murine proteins

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 months since prior rituximab, tositumomab, or ibritumomab
  • No prior allogeneic stem cell transplantation
  • No other concurrent immunotherapy (e.g., interferons, vaccines, or other cellular products)

Chemotherapy:

  • At least 2 years since prior fludarabine or cladribine
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • No concurrent systemic corticosteroids except to treat toxicity from chemotherapy or cellular immunotherapy

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • At least 4 weeks since prior immunosuppressive therapy and recovered
  • No concurrent pentoxifylline
  • No other concurrent investigational agents

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • University of Washington School of Medicine

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A Phase I Study To Evaluate The Safety Of Cellular Immunotherapy Using Genetically Modified Autologous Cd20-Specific Cd8+ T Cell Clones For Patients With Relapsed Cd20+ Indolent Lymphomas

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of biological therapy after chemotherapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety and toxicity of cellular immunotherapy with autologous CD8+ cytotoxic T-lymphocyte clones after chemotherapy comprising cyclophosphamide, vincristine, and prednisone in patients with relapsed or refractory CD20+ indolent lymphomas or mantle cell lymphoma.

Secondary

  • Determine the duration of in vivo persistence of adoptively transferred CD20-specific CD8+ cytotoxic T-lymphocyte clones in the absence and presence of subcutaneous interleukin-2 in these patients.
  • Assess the trafficking of CD8+ cytotoxic T-lymphocyte clones to lymph nodes in these patients treated with this regimen.
  • Determine immune response and tumor response in patients treated with this regimen.

OUTLINE: This is an open-label, pilot study.

  • Leukapheresis: Patients undergo leukapheresis. Selected CD20-specific CD8+ cells are cultured to expand the cytotoxic T lymphocytes (CTL), which are then cloned.
  • Chemotherapy:

Patients receive oral cyclophosphamide and oral prednisone on days 1-5 and vincristine IV on day 1. Courses repeat every 3-4 weeks for a total of 6 courses.

  • Immune cell infusion:

Beginning 4 weeks after the last course of chemotherapy (and lymph nodes ≤ 5 cm diameter or ≤ 5,000 circulating CD20+ lymphocytes/mm^3), patients receive autologous CD8+ CTL clones IV over 30 minutes. Courses repeat every 2-5 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. The last 6 patients receive interleukin-2 subcutaneously every 12 hours for 14 days, beginning 2 hours after the last infusion of CD8+ CTL clones.

After course 2 or 3 of immune cells, all patients undergo surgical lymph node biopsy to determine if immune cells are moving to the lymph nodes.

Patients are followed monthly for 1 year and then annually for 2 years.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 4 years.

Conditions
Leukemia, Lymphoma
Being tested
aldesleukin, therapeutic autologous lymphocytes, cyclophosphamide, prednisone, vincristine sulfate
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, refractory chronic lymphocytic leukemia
Medical subject headings
Leukemia, Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

What is being measured

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

  1. Safety and toxicity by NCI CTC toxicity scale in patients w/ recurr. or refract. CD20+ follicular lymphoma who are not candidates for high dose chemoradiotx and stem cell transplant during each infusion, weekly for 4 wks and then monthly for a yr

Secondary outcomes (4)

  1. Duration of in vivo persistence of adoptively transferred CD20-specific CD8+ T cell clones by flow cytometry and quantitative polymerase chain reaction (qPCR) during each infusion, weekly for 4 weeks, and then monthly for a year

  2. Trafficking of CD8+ CD20-specific T cell clones to lymph nodes by Gamma camera imaging during each infusion, weekly for 4 weeks, and then monthly for a year

  3. Development of host anti-scFvFc:zeta (and anti-NeoR) immune responses by ELISA and chromium release assays during each infusion, weekly for 4 weeks, and then monthly for a year

  4. Tumor responses to cyclophosphamide, vincristine, and prednisone (CVP) and to cytotoxic T-lymphocyte (CTL) infusions by Cheson criteria during each infusion, weekly for 4 weeks, and then monthly for a year

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2000
  3. Study completionJul 2010

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 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00012207
Sponsor's protocol ID
1503.00
Other IDs
FHCRC-1503.00, NCI-G01-1921, CDR0000068494
Status last verified
Aug 2010
First submitted
3 Mar 2001
Last updated
24 Aug 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Till BG, Jensen MC, Wang J, Chen EY, Wood BL, Greisman HA, Qian X, James SE, Raubitschek A, Forman SJ, Gopal AK, Pagel JM, Lindgren CG, Greenberg PD, Riddell SR, Press OW. Adoptive immunotherapy for indolent non-Hodgkin lymphoma and mantle cell lymphoma using genetically modified autologous CD20-specific T cells. Blood. 2008 Sep 15;112(6):2261-71. doi: 10.1182/blood-2007-12-128843. Epub 2008 May 28.

    PubMed 18509084

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing aldesleukin, therapeutic autologous lymphocytes and cyclophosphamide in people with Leukemia and Lymphoma, run by Fred Hutchinson Cancer Center at 3 sites in United States.

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and toxicity by NCI CTC toxicity scale in patients w/ recurr. or refract. CD20+ follicular lymphoma who are not candidates for high dose chemoradiotx and stem cell transplant during each infusion, weekly for 4 wks and then monthly for a yr. 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 NCT00012207, 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 24 Aug 2010.

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