AzTrials
AzTrials

LeukemiaPhase 1NCT00176475

Irradiated Donor Lymphocytes and Rituximab in Treating Patients With Relapsed or Refractory Lymphoproliferative Disease

A Phase 1 study testing rituximab and therapeutic allogeneic lymphocytes in people with Leukemia and Lymphoma, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may help the patient's immune system kill 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
rituximab and therapeutic allogeneic lymphocytes
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Jan 2005to Feb 2008
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed lymphoproliferative disease
  • CD20-positive disease
  • Bidimensionally measurable disease OR abnormal cells detected in blood
  • Resistant or refractory to standard therapies and/or unlikely to benefit from additional standard therapies* AND meets 1 of the following criteria:
  • Disease with anticipated response rate < 20% after treatment with rituximab alone, including any of the following:
  • Diffuse large cell lymphoma
  • B-cell lymphoblastic lymphoma
  • Burkitt's lymphoma
  • Acute lymphocytic leukemia
  • Relapsed or progressive disease after prior treatment with rituximab, including any of the following:
  • Hodgkin's lymphoma
  • Hairy cell leukemia
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma meeting any of the following criteria:
  • Received prior fludarabine phosphate-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
  • Received prior anti-CD52 monoclonal antibody therapy and relapsed within 1 year of treatment OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy)
  • Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
  • B-cell prolymphocytic leukemia meeting any of the following criteria:
  • Received prior fludarabine phosphate- or alkylating agent-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
  • Received prior anti-CD52 monoclonal antibody therapy OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy)
  • Lymphoplasmacytic lymphoma, marginal zone lymphoma, mucosa-associated lymphoid tissue lymphoma, or follicular lymphoma meeting any of the following criteria:
  • Received prior fludarabine phosphate- and/or alkylating agent-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
  • Received prior anti-CD20 monoclonal antibody therapy and relapsed within 1 year of treatment OR ineligible to receive such therapy
  • Received prior radioconjugated anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy
  • Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
  • Multiple myeloma meeting any of the following criteria:
  • Received prior alkylating agent-, thalidomide-, corticosteroid-, or bortezomib-containing regimens and relapsed after 1 year of treatment OR ineligible to receive such therapies due to comorbidities or allergies
  • Received prior high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR ineligible to receive such therapy
  • Mantle cell lymphoma meeting the following criteria:
  • Received prior combination chemotherapy and anti-CD20 monoclonal antibody therapy and relapsed after treatment OR ineligible to receive such therapy
  • Diffuse large B-cell lymphoma meeting any of the following criteria:
  • Received prior combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
  • Received prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR not a candidate to receive such therapy
  • Received prior radiolabeled anti-CD20 monoclonal antibody therapy for transformed large cell lymphoma OR ineligible to receive such therapy
  • Burkitt's lymphoma meeting any of the following criteria:
  • Received prior combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
  • Received prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR ineligible to receive such therapy
  • Lymphomatoid granulomatosis meeting any of the following criteria:
  • Received prior single-agent or combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
  • Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
  • Acute lymphocytic leukemia meeting any of the following criteria:
  • Received prior multi-agent combination chemotherapy administered in sequential induction, consolidation, and maintenance courses and relapsed during or after treatment OR ineligible to receive such therapy
  • Received prior chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplantation (HSCT) and relapsed after treatment OR not a candidate for such therapy
  • Received prior treatment with chemotherapy with or without radiotherapy followed by allogeneic HSCT and relapsed after treatment (or not a candidate for such therapy) AND demonstrates persistent cytogenetic, fluorescent in situ hybridization, or molecular (reverse transcriptase-polymerase chain reaction) evidence of the bcr-abl fusion gene despite 6 weeks of treatment with imatinib mesylate NOTE: *Not eligible to receive standard available salvage regimens anticipated to result in durable remission
  • No active CNS malignancy
  • Not considered a candidate for allogeneic HSCT
  • HLA-partially matched (≥ 2/6) related donor available

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy > 3 months
  • Not pregnant
  • Negative pregnancy test
  • Fertile women must use effective contraception
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST < 3.0 times ULN
  • Cardiac ejection fraction > 35%
  • Absolute neutrophil count > 1,000/mm³ (without cytokines)
  • Platelet count > 50,000/mm³ (untransfused)
  • No significant organ dysfunction
  • No active uncontrolled infections
  • No hypersensitivity reaction to rituximab that has precluded completion of a 4-week course of rituximab therapy
  • No uncontrolled psychiatric illness or medical condition that would preclude tolerance of study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy for at least 7 days
  • More than 30 days since prior cytotoxic chemotherapy
  • At least 14 days since prior steroids
  • At least 14 days since prior radiotherapy to non-target lesions

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes in Conjunction With Rituximab for Selected Patients With CD20 + Malignancies

RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may help the patient's immune system kill 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 irradiated donor lymphocytes together with rituximab may kill more cancer cells.

PURPOSE: This clinical trial is studying the side effects and how well giving irradiated donor lymphocytes together with rituximab works in treating patients with relapsed or refractory lymphoproliferative disease.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the toxicity of irradiated HLA-partially matched related donor lymphocytes when administered with rituximab in patients with relapsed or refractory CD20-positive lymphoproliferative disease.
  • Determine the efficacy of this regimen in these patients.

Secondary

  • Correlate response with Fc receptor FcγIIIA polymorphisms or predicted HLA-directed natural killer cell reactivity.

OUTLINE: This is a pilot study.

  • Rituximab therapy: Patients receive rituximab IV on days -1, 6, 13, and 20. Treatment repeats approximately every 4 months in the absence of disease progression or unacceptable toxicity.
  • Donor lymphocyte infusion: Patients receive irradiated donor lymphocytes IV over 1 hour on day 0. Treatment repeats every 8-16 weeks (alternating with courses of rituximab therapy) for up to 6 donor lymphocyte infusions in the absence of disease progression or unacceptable toxicity.

Peripheral blood is collected periodically during study for correlative laboratory studies. Blood samples are analyzed for FcγIIIA polymorphism by fluorescent in situ hybridization or by reverse transcriptase-polymerase chain reaction. Survival of donor lymphocytes is assessed by chimerism studies.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Being tested
rituximab, therapeutic allogeneic lymphocytes
Keywords
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult acute lymphoblastic leukemia, refractory chronic lymphocytic leukemia, recurrent small lymphocytic lymphoma, refractory hairy cell leukemia, prolymphocytic leukemia, recurrent marginal zone lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, refractory multiple myeloma, recurrent mantle cell lymphoma, recurrent adult grade III lymphomatoid granulomatosis, Waldenstrom macroglobulinemia, splenic marginal zone lymphoma
Medical subject headings
Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Lymphoma, B-Cell, Marginal Zone, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Hodgkin Disease

What participants receive

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

  • rituximabBiological

    Patients will receive a single day infusion of standard dose rituximab (375 mg/m2) on days -1, 6, 13, 20 approximately every 4 months (in conjunction with alternating doses of the lymphocyte infusion).

  • therapeutic allogeneic lymphocytesBiological

    The product will then be assigned to the specific patient and the released product will be transported to and administered to the patient at CINJ, after premedication of the patient with acetaminophen 650 mg PO and diphenhydramine- HCl 25 mg PO. Blood product administration will be every 8 weeks and undertaken according to CINJ standard procedures

Study groups in NCT00176475
Study groupRoleWhat they receive
Therapeutic allogeneic lymphocytes with rituximabExperimentalNot described
Receives: Biological: rituximab; Biological: therapeutic allogeneic lymphocytes

What is being measured

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

  1. Toxicity as assessed by NCI CTCAE v3.0

    Measured: 4 years

Secondary outcomes (1)
  1. Efficacy

    Measured: 4 years

Timeline

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

  1. First posted15 Sep 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Why it stopped: slow accrual

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00176475
Sponsor's protocol ID
CDR0000540171
Other IDs
P30CA072720, CINJ-010406
Status last verified
Sep 2013
First submitted
12 Sep 2005
Last updated
17 Sep 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rituximab and therapeutic allogeneic lymphocytes in people with Leukemia and Lymphoma, run by University of Medicine and Dentistry of New Jersey at 1 site 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: stopped early, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: slow accrual). Results are not available in the source record.

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?

Toxicity as assessed by NCI CTCAE v3.0 (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2013.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in