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AzTrials

LeukemiaPhase 2NCT00387959

Chemotherapy, Radiation Therapy, Rituximab, and Umbilical Cord Blood Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

A Phase 2 study testing filgrastim, rituximab and cyclophosphamide in people with Leukemia and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site 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 low doses of chemotherapy, such as cyclophosphamide and fludarabine, total-body irradiation, and rituximab before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Leukemia, Lymphoma
What is being tested?
filgrastim, rituximab and cyclophosphamide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
Jul 2006to Apr 2014
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:
  • CD20+* aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following:
  • Diffuse large cell (DLC) NHL meeting 1 of the following criteria:
  • Relapsed disease after initial therapy but failed to mobilize or had bone marrow involvement and therefore is not suitable for an autologous stem cell transplantation
  • High-intermediate or high-risk, second-line, age-adjusted International Prognostic Index (IPI) score and in second complete remission (CR) or partial remission (PR) after prior autologous stem cell transplantation
  • Failed prior autologous stem cell transplantation and in at least PR after salvage chemotherapy
  • Large cell transformation of indolent NHL/chronic lymphocytic leukemia (CLL) meeting the following criteria:
  • CR/PR of the large cell component of disease after salvage chemotherapy or autologous stem cell transplantation
  • Mantle cell lymphoma meeting 1 of the following criteria:
  • High-risk, as defined by p53 positivity and in first CR/PR after initial therapy
  • Relapsed disease after initial therapy and in second or third CR/PR after salvage chemotherapy
  • CD20+* indolent NHL or CLL meeting the following criteria:
  • Must be in second or subsequent progression (pre-allograft cytoreduction necessary but CR/PR not required)
  • Indolent NHL includes, but is not limited to, any of the following:
  • Follicular NHL
  • Small cell NHL
  • Marginal zone NHL NOTE: *CD20 positivity must be demonstrated within the past 12 months
  • Relapsed disease must be biopsy proven
  • Prior pre-allograft cytoreduction may have included 1 of the following:
  • Single autologous stem cell transplantation with high-dose chemotherapy conditioning, if appropriate, and no conditioning prior to transplantation
  • Two or more courses of intensive combination chemotherapy (e.g., rituximab, irinotecan hydrochloride, cetuximab, epirubicin hydrochloride [RICE]) as appropriate according to diagnosis and prior therapy
  • Heavily pre-treated CLL patients in whom further combination chemotherapy is not appropriate may receive single-agent intermediate-dose cyclophosphamide for 2-3 courses
  • No mantle cell or DLC NHL with progressive disease at allograft work-up
  • No suitable matched related or unrelated donor available
  • Two umbilical cord blood (UCB) units available meeting the following criteria:
  • Units and recipient must be ≥ 4/6 HLA-A and -B antigen and DRB1 allele matched
  • Each unit must have ≥ 1.5 x 10^7 total nucleated cells/recipient body weight

PATIENT CHARACTERISTICS:

  • Karnofsky performance score 70-100%
  • Creatinine clearance ≥ 50 mL/min
  • Bilirubin < 2.5 mg/dL
  • AST and ALT ≤ 3 times upper limit of normal (unless due to benign congenital hyperbilirubinemia)
  • Spirometry and corrected DLCO ≥ 50% normal
  • LVEF ≥ 40%
  • Albumin ≥ 2.5 g/dL
  • No active and uncontrolled infection at time of transplantation, including active infection with Aspergillus or other mold
  • No HIV positivity
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 120 days since prior autologous stem cell transplantation
  • No more than 60 days since prior chemotherapy
  • No prior allogeneic transplantation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With B Cell Lymphoid Malignancies

RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, total-body irradiation, and rituximab before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with rituximab and an umbilical cord blood transplant works in treating patients with B-cell non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the overall and event-free survival at 1 year in patients with B-cell lymphoid malignancies treated with a nonmyeloablative conditioning regimen, rituximab, and umbilical cord blood (UCB) transplantation (UCBT).

Secondary

  • Determine the speed of neutrophil and platelet recovery post allograft in these patients.
  • Determine the incidence and speed of donor-derived engraftment and contribution of each UCB unit to engraftment in these patients.
  • Determine the incidence and severity of acute graft-vs-host disease (GVHD) at 100 days in these patients.
  • Determine the incidence and severity of chronic GVHD at 1 year in these patients.
  • Determine the incidence of serious infectious complications and correlate with laboratory measurements of immune recovery in these patients.
  • Determine the response to vaccination after UCBT in these patients.
  • Determine the incidence of treatment-related mortality at 100 days and 180 days in these patients.
  • Determine the incidence of malignant relapse or disease progression at 1 and 2 years in these patients.
  • Determine the probabilities of overall and event-free survival at 2 years after UCBT in these patients.
  • Determine the performance of laboratory studies investigating double-unit biology and correlate with unit engraftment in these patients.

OUTLINE:

  • Pre-transplant rituximab therapy: Patients receive rituximab IV on days -8 or -7 and on day -4.
  • Nonmyeloablative conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV on day -6. Patients also undergo total-body irradiation on day -1.
  • Umbilical cord blood transplantation: Patients undergo umbilical cord blood transplantation on day 0. Patients receive filgrastim (G-CSF) IV or subcutaneously beginning on day 7 and continuing until blood counts recover.
  • Post-transplant rituximab therapy: Patients receive rituximab IV on days 7, 14, 21, and 28.
  • Graft-vs-host disease prophylaxis: Patients receive cyclosporine IV over 2-4 hours or orally twice daily on days -3 to 100, followed by a taper. Patients also receive mycophenolate mofetil IV or orally three times daily on days -3 to 45, followed by a taper.

Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

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

Conditions
Leukemia, Lymphoma
Keywords
recurrent mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent marginal zone lymphoma, recurrent adult diffuse small cleaved cell lymphoma, splenic marginal zone lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma
Medical subject headings
Leukemia, Lymphoma, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Non-Hodgkin, Lymphoma, Follicular

What participants receive

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

Study groups in NCT00387959
Study groupRoleWhat they receive
Unrelated Donor Umbilical Cord TransplantExperimentalNon-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
Receives: Biological: filgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: cyclosporine; Drug: fludarabine phosphate; Drug: mycophenolate mofetil; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: umbilical cord blood transplantation; Radiation: total-body irradiation

What is being measured

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

  1. Survival at 1 Year After Transplantation

    The number of patients survival status 1 year after transplantation

    Measured: 1 Year 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 posted13 Oct 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionApr 2014
  4. Study completionApr 2014

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00387959
Sponsor's protocol ID
06-066
Other IDs
MSKCC-06066
Status last verified
Dec 2015
First submitted
12 Oct 2006
Last updated
1 Feb 2016
Data monitoring committee
Yes

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 Memorial Sloan Kettering Cancer Center 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: finished, as of the sponsor's last update on 1 Feb 2016. 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 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 1 Feb 2016). 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?

Survival at 1 Year After Transplantation (time frame: 1 Year after transplant). 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 1 Feb 2016.

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