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LeukemiaPhase 3NCT00003056

Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation

A Phase 3 study testing cyclosporine and cyclosporine and methotrexate in people with Leukemia and Lymphoma, run by Baxalta now part of Shire at 13 sites in 2 countries.

Terminated

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

Official record
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Trial summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Leukemia, Lymphoma, Graft Versus Host Disease
What is being tested?
cyclosporine and cyclosporine and methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
13 sitesin 2 countries
Study dates
1 Apr 1997to 1 Jun 2003
Phase
Phase 3
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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

DISEASE CHARACTERISTICS: - Acute lymphocytic leukemia (ALL) with documented chemosensitivity (complete response [CR], partial response [PR], or minor response [MR]) in first or second remission, first or second relapse, or high risk ALL with Ph positive 9/22 translocation; OR - Acute myelogenous leukemia (AML) with documented chemosensitivity (CR, PR, or MR) in first or second remission, or first or second relapse; OR - Chronic myelogenous leukemia (CML), chronic or accelerated, that is not in blast crisis; OR - Hodgkin's disease or non-Hodgkin's lymphoma with documented chemosensitivity in first or second relapse Consenting human lymphocyte antigen (HLA)-identical related donor required No active central nervous system (CNS) or skin leukemia involvement No disease that requires additional mediastinal radiation

PATIENT CHARACTERISTICS: Age: 18-55 Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 times normal serum glutamate oxalo-acetate transaminase (SGOT) less than 2 times normal Renal: Creatinine less than 1.5 times normal Cardiovascular: Left ventricular ejection fraction at rest at least 40% or within normal range Pulmonary: diffusing capacity of the lung for carbon monoxide (DLCO) greater than 45% of predicted or within normal range Other: HIV negative At least 2 weeks since any active infection requiring intravenous treatment with antifungal, antibacterial or antiviral agents with the exception of coagulase negative staphylococcal line infection No coexisting medical problems that would significantly increase the risk of the transplant procedure Not pregnant or nursing

PRIOR CONCURRENT THERAPY: No more that 2 prior therapy regimens Biologic therapy: No prior autologous or allogeneic bone marrow or peripheral blood stem cell transplant Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy subject to dose requirements Surgery: Not specified Other: At least 2 weeks since intravenous treatment with antifungal, antibacterial or antiviral agents, except for treatment of coagulase negative staphylococcal infection of an IV or central line

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States12 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Hackensack, New Jersey

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    Lawrence, Kansas

  • Study site

    Los Angeles, California

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Richmond, Virginia

  • Study site

    Saint Paul, Minnesota

  • Study site

    San Antonio, Texas

  • Study site

    St Louis, Missouri

Other trials in United States

Australia1 site

  • Study site

    Adelaide, South Australia

Other trials in Australia

About this study

Official title: Peripheral Blood Stem Cell Transplantation in Patients With Advanced Malignancies Eligible for Allogeneic Transplantation From Matched Related Donors: A Randomized Study of Cyclosporine/Methotrexate or Cyclosporine/T-Cell Depletion (CD34 Cell Selection) for GVHD Prophylaxis

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues.

PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine plus methotrexate with cyclosporine plus T cell depletion for prevention of graft-versus-host disease during peripheral stem cell transplantation in patients who have advanced leukemia or lymphoma who are eligible for transplanted peripheral stem cells from a donor.

Read the detailed description

OBJECTIVES: I. Demonstrate that the graft versus host disease (GVHD) prophylactic regimen consisting of T-cell depletion and cyclosporine results in less toxicity than the control regimen of methotrexate and cyclosporine in recipients of peripheral blood stem cell transplants. II. Monitor safety of the two regimens in order to assure that the treatment regimen dose not result in any increase in serious or unexpected toxicities, does not compromise the efficacy of GVHD prophylaxis, and does not compromise the efficacy of the disease therapy.

OUTLINE: This is a multicenter, controlled, randomized trial. Patients are assigned to high or low risk groups and randomized to the control or treatment arms. Patients are stratified by risk group and by site. Mobilization, apheresis, and successful cryopreservation of the minimum number of CD34 cells for transplant has to be achieved prior to initiating cytoreductive therapy. Following intensive cytoreductive therapy, patients receive either unselected peripheral blood stem cells (PBSC) together with the control graft versus host disease (GVHD) prophylaxis regimen or CD34+ cells isolated from PBSC with cyclosporine. In the control group, GVHD prophylaxis consists of two drug therapies, cyclosporine and methotrexate. The cyclosporine is administered first by IV continuous infusion and then later orally, twice a day, in decreasing increments for 180 days. Methotrexate is administered by IV on days 1, 3, 6, and 11. Cyclosporine is discontinued after day +180 if there is no evidence of GVHD. In the treatment group, GVHD prophylaxis consists of T cell depletion of the transplant product using the Isolex positive selection procedure (Isolex selected CD34+ cells) and cyclosporine. The cyclosporine is administered at the same doses and increments as in the control group. In cases where there still is acute or chronic GVHD, the patient is given the appropriate salvage regimens. Patients are followed monthly for 6 months after transplant, and then for 2 years to monitor relapses.

PROJECTED ACCRUAL: There will be 200 patients accrued (100 in each arm) in this study.

Being tested
cyclosporine, cyclosporine and methotrexate
Keywords
recurrent adult diffuse small cleaved cell lymphoma, adult acute myeloid leukemia in remission, recurrent grade 2 follicular lymphoma, accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, recurrent grade 1 follicular lymphoma, recurrent adult lymphoblastic lymphoma, recurrent marginal zone lymphoma, chronic phase chronic myelogenous leukemia, recurrent small lymphocytic lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult acute lymphoblastic leukemia, recurrent adult immunoblastic large cell lymphoma, graft versus host disease, recurrent adult diffuse mixed cell lymphoma, recurrent mantle cell lymphoma, splenic marginal zone lymphoma, recurrent adult acute myeloid leukemia, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
Medical subject headings
Leukemia, Lymphoma, Graft vs Host Disease, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Leukemia, Myeloid, Accelerated Phase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, B-Cell, Marginal Zone

What participants receive

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

Study groups in NCT00003056
Study groupRoleWhat they receive
Unselected peripheral blood haemopoietic stem cells (PBSC)Active comparatorUnselected PBSC together with control graft versus host disease (GVHD) prophylaxis - Control
Receives: Drug: cyclosporine and methotrexate
CD34+ cells isolated from PBSCExperimentalCD34+ cells isolated from PBSC using the Isolex 300i system together with cyclosporine
Receives: Drug: cyclosporine

What is being measured

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

  1. Time to neutrophil engraftment

    Measured: Month 1, post-transplant

  2. Time to neutrophil engraftment

    Measured: Month 2, post-transplant

  3. Time to neutrophil engraftment

    Measured: Month 3, post-transplant

  4. Time to neutrophil engraftment

    Measured: Month 4, post-transplant

  5. Time to neutrophil engraftment

    Measured: Month 5, post-transplant

  6. Time to neutrophil engraftment

    Measured: Month 6, post-transplant

Timeline

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

  1. First posted24 May 2004 (estimated)
  2. Study start1 Apr 1997
  3. Primary completion1 Jun 2003
  4. Study completion1 Jun 2003

Why it stopped: Interim analysis indicated study should be terminated

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003056
Sponsor's protocol ID
BAXTER-302302
Other IDs
MCV-CCHR-9703-2A, CDR0000065709, NCI-G97-1311
Status last verified
May 2021
First submitted
1 Nov 1999
Last updated
6 May 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cyclosporine and cyclosporine and methotrexate in people with Leukemia and Lymphoma, run by Baxalta now part of Shire at 13 sites in 2 countries.

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 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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: Interim analysis indicated study should be terminated). 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?

Time to neutrophil engraftment (time frame: Month 1, post-transplant). The study lists 6 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 NCT00003056.

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 6 May 2021.

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