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Acute Myelogenous LeukemiaPhase 2NCT00975975

Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

A Phase 2 study testing Basiliximab in people with Acute Myelogenous Leukemia and Acute Lymphocytic Leukemia, run by Indiana University 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

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Basiliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
Sep 2009to Nov 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute myelogenous leukemia:
  • Second or subsequent remission; patient over 18 yrs of age.
  • Relapsed after autologous HC transplant, over 18 years of age.
  • First remission, Philadelphia chromosome + over age 18.
  • Secondary AML, in first or subsequent remissions.
  • Acute lymphocytic leukemia:
Show all 49Show fewer
  • Philadelphia chromosome + over the age of 50, first or subsequent remission.
  • Relapse following Autologous HC transplantation, ages over 50.
  • Second or subsequent remission over the age of 50
  • Chronic myelogenous leukemia:
  • First or second chronic phase over the age of 18.
  • Accelerated phase over the age of 18.
  • Must have failed or been intolerant to a standard tyrosine kinase inhibitor.
  • Chronic lymphocytic leukemia:
  • Failed nucleoside-based therapy, ages >18.
  • Myelodysplasia:
  • All-risk categories, age greater than 18.
  • Non-Hodgkin's Lymphoma, less than 76 years of age
  • Relapsed diffuse aggressive NHL (intermediate and high grade) that fails to achieve CR or PR to conventional salvage chemotherapy.
  • Aggressive NHL includes diffuse large B cell lymphoma, diffuse mixed small and large cell lymphoma, follicular lymphoma for grade 3 (follicular large cell lymphoma), T or B cell lymphoblastic lymphoma, diffuse small noncleaved (Burkett's or Burkett-like ) lymphoma, mantle cell lymphoma, peripheral T cell lymphoma, anaplastic large cell lymphoma, and other diffuse aggressive lymphomas that are not otherwise classifiable
  • Aggressive NHL that has relapsed following autologous HCT. Patients that respond to additional treatment for post-transplant relapse are eligible.
  • Aggressive NHL that does not achieve CR or PR with primary chemotherapy (i.e., primary induction failure).
  • Low-grade lymphoma refractory to standard therapy, including the following:
  • small cell lymphocytic lymphoma,
  • follicular lymphoma of grades 1 and 2 (follicular small cleaved and follicular mixed small and large cell lymphoma)
  • marginal cell lymphoma, splenic lymphoma),
  • lymphoplasmacytic lymphoma and
  • other lymphomas not otherwise classifiable.
  • Patients with low-grade lymphoma must have experienced progressive disease after receiving three or more of the following regimens:
  • alkylator-based therapy (cyclophosphamide/ vincristine/ prednisone) chlorambucil, monoclonal antibody based therapy (e.g., rituximab, Campath-1H, radiolabelled CD20+ antibodies);
  • nucleoside analog-based therapy (e.g., fludarabine, cladribine).)
  • Patients with marginal zone lymphoma or gastric MALT type associated with Helicobacter pylori infection must have progressed after receiving appropriate antibiotic therapy as well as three or more regimens as described above
  • Mantle cell, ages 18-75.
  • Hodgkin's Disease, ages 18-75.
  • Relapsed or refractory disease after autologous transplant.
  • Multiple Myeloma, ages 18-75
  • Recurrent disease after two medical therapies
  • Relapse following autologous transplant
  • Myelofibrosis, age greater than 18 years
  • Severe aplastic anemia (refractory to immunosuppressive therapy); age greater than 18 years
  • Patients with aplastic anemia must have marrow cellularity ≤ 10% plus 2 of the following:
  • Absolute granulocyte count <500/mm3
  • Corrected reticulocyte count <1%
  • Untransfused platelet count <20,000/mm3 on at least 2 occasions
  • Hemoglobin <9 g/dL (adults) or < 8 g/dL (children) on at least 2 occasions
  • Paroxysmal nocturnal hemoglobinuria; age greater than 18 years.
  • Renal function: creatinine greater than 2.5
  • Donor Requirement:
  • Must have a fully HLA-matched (10 of 10 Antigen matched) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis

Who cannot join

  • Active CNS disease (the presence of leukemic blasts in the CSF)
  • Pregnancy or breast-feeding.
  • Inability to give informed consent.
  • AST, ALT, total bilirubin >3x upper limit of normal.
  • Creatinine > 2 or creatinine clearance < 50mL/hr. If patient has a creatinine of > 2 or creatinine clearance < 50mL/hr and it is due to the disease process then the patient will not be excluded based on this.
  • Fractional shortening by echocardiogram not within normal limits per institution or LVEF of < 40 %.
  • Pulmonary function: DLCO not within institutional normal limits or DLCO less than 45% of normal predicted, corrected for anemia
  • Prior allogeneic transplant.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent GVHD After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues.

Read the detailed description

This study is for patients with a blood condition or myelodysplasia (bone marrow disease) which has either not responded to treatment or is not treatable by conventional/routine medical treatments. Bone marrow transplantation is a medical treatment that involves giving high doses of chemotherapy followed by the transplantation of the blood-forming and immune cells from a relative or from a "matched" unrelated person through the National Marrow Donor Program, in an attempt to cure disease in the recipient (the person receiving the donated cells). Nonmyeloablative (bone-marrow preservation) bone marrow transplantation is a relatively new technique in which lower than usual doses of chemotherapy are given before transplantation, in hopes of reducing adverse side effects of the chemotherapy in transplant patients. Nonmyeloablative bone marrow transplantation has several advantages which doctors have determined are beneficial for this condition.

This research is being done because the complication of graft-versus-host disease can be bad for a person and there is no completely safe and effective way to prevent this complication. We know that cyclosporine helps but would like to know if the addition of basiliximab, given with cyclosporine, will decrease the incidence and/or severity of graft-versus-host disease after a transplant known as nonmyeloablative or "mini" transplant.

Being tested
Basiliximab
Keywords
Paroxysmal nocturnal hemoglobinuria, severe aplastic anemia, Mantle cell
Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell, Anemia, Refractory, with Excess of Blasts, Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma

What participants receive

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

  • BasiliximabDrug

    Also called Simulect

    Basiliximab given 1 time on Day +7 or Day +9.

Study groups in NCT00975975
Study groupRoleWhat they receive
BasiliximabExperimentalBasiliximab will be given by IV on Day +7 post transplant for recipients of matched unrelated cells. Basiliximab will be given by IV on Day +9 post transplant for recipients of matched related cells.
Receives: Drug: Basiliximab

What is being measured

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

  1. Grade 3-4 Acute GVHD Rate

    The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD

    Measured: Transplant (Day 0) up to 1 year

Secondary outcomes (2)

  1. Time to Neutrophil Engraftment

    Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.

    Measured: Transplant (Day 0) up to 1 year

  2. Time to Platelet Engraftment

    Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.

    Measured: Transplant (Day 0) up to 1 year

Timeline

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

  1. First posted14 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionOct 2012
  4. Study completionNov 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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00975975
Sponsor's protocol ID
0908-04; IUCRO-0256
Status last verified
Jan 2016
First submitted
11 Sep 2009
Last updated
26 Feb 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Basiliximab in people with Acute Myelogenous Leukemia and Acute Lymphocytic Leukemia, run by Indiana University 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?

The sponsor lists 49 inclusion and 8 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 26 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 26 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?

Grade 3-4 Acute GVHD Rate (time frame: Transplant (Day 0) up to 1 year). 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 NCT00975975.

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 26 Feb 2016.

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