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Chronic Myeloproliferative DisordersPhase 2NCT00346359

Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer

A Phase 2 study testing anti-thymocyte globulin, busulfan and fludarabine phosphate in people with Chronic Myeloproliferative Disorders and Graft Versus Host Disease, run by Fred Hutchinson 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 fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and 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 Up to 65 years
What is being tested?
anti-thymocyte globulin, busulfan and fludarabine phosphate
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteUnited States
Study dates
Mar 2006to Nov 2007
Phase
Phase 2
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 Up to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following myeloid malignancies:
  • Chronic myelogenous leukemia meeting 1 of the following criteria:
  • Chronic phase
  • Accelerated phase
  • Treated blast phase
  • Acute myeloid leukemia meeting 1 of the following criteria:
  • In remission
  • In early relapse, defined as < 10% marrow blasts
  • Myelodysplastic syndromes, including all risk groups
  • Other myeloproliferative disorders
  • HLA-A, -B, -C, -DRB1, and -DQB1 matched related or unrelated donor available

PATIENT CHARACTERISTICS:

  • No other disease that would severely limit life expectancy
  • AST ≤ 2 times normal
  • Creatinine ≤ 2 times normal OR creatinine clearance ≥ 60 mL/min
  • No cardiac insufficiency requiring treatment
  • No symptomatic coronary artery disease
  • PO_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR PO _2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted
  • HIV negative
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No post-transplantation growth factor during methotrexate administration

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: Conditioning For Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and 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 system and help destroy any remaining abnormal or 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 antithymocyte globulin, tacrolimus, and methotrexate before or after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan followed by donor peripheral stem cell transplant and antithymocyte globulin, tacrolimus, and methotrexate works in treating patients with myeloid cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the incidence and severity of acute graft-versus-host disease (GVHD) in patients with myeloid malignancies treated with conditioning regimen comprising fludarabine phosphate and busulfan followed by allogeneic peripheral blood stem cell transplantation and GVHD prophylaxis comprising antithymocyte globulin, tacrolimus, and methotrexate.
  • Determine the incidence of donor engraftment in patients treated with this regimen.

Secondary

  • Determine the pharmacokinetics of IV busulfan, including interdose variability and evaluation of a limited sampling strategy, in these patients.
  • Determine the pharmacokinetics of antithymocyte globulin in these patients.
  • Determine the pharmacokinetics of fludarabine phosphate and its effect on lymphocytes in these patients.
  • Determine the incidence of specific toxic effects ≥ grade 3 in patients treated with this regimen.
  • Determine the incidence and severity of chronic GVHD in these patients.
  • Determine the incidence of nonrelapsing mortality at 100 days and at 1 year after transplantation in these patients.
  • Determine the incidence of relapse in these patients.
  • Determine relapse-free survival of these patients.
  • Determine the incidence of Epstein-Barr virus activation in these patients.

OUTLINE:

  • Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and busulfan IV over 3 hours on days -5 to -2. Prior to the conditioning regimen, patients whose cerebrospinal fluid is positive for malignant cells receive intrathecal methotrexate or cranial irradiation for CNS prophylaxis.
  • Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients receive filgrastim (G-CSF)-mobilized allogeneic PBSCs IV on day 0.
  • Graft-versus-host disease prophylaxis: Patients receive antithymocyte globulin IV over at least 10 hours on days -3 to -1. They also receive tacrolimus orally twice daily or IV continuously beginning on day -1 and continuing until up to day 55, followed by a taper until day 180 in the absence of graft-versus-host disease. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

After completion of study treatment, patients are followed annually.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Being tested
anti-thymocyte globulin, busulfan, fludarabine phosphate, methotrexate, tacrolimus
Keywords
graft versus host disease, chronic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, atypical chronic myeloid leukemia, chronic myelomonocytic leukemia, juvenile myelomonocytic leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, secondary acute myeloid leukemia, chronic eosinophilic leukemia, chronic idiopathic myelofibrosis
Medical subject headings
Myeloproliferative Disorders, Graft vs Host Disease, Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myeloid, Chronic-Phase, Blast Crisis, Leukemia, Myeloid, Accelerated Phase

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. Incidence and severity of acute graft-versus-host disease (GVHD)

  2. Incidence of donor engraftment

Secondary outcomes (9)

  1. Pharmacokinetics of IV busulfan including interdose variability and evaluation of a limited sampling strategy

  2. Pharmacokinetics of antithymocyte globulin

  3. Pharmacokinetics of fludarabine phosphate and its effect on lymphocytes

  4. Incidence of specific toxic effects ≥ grade 3

  5. Incidence and severity of chronic GVHD

  6. Incidence of nonrelapsing mortality at 100 days and at 1 year after transplantation

  7. Incidence of relapse

  8. Relapse-free survival

  9. Incidence of Epstein-Barr virus activation and post-transplantation lymphoproliferative disease

Timeline

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

  1. First posted29 Jun 2006 (estimated)
  2. Study startMar 2006
  3. Study completionNov 2007

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
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00346359
Sponsor's protocol ID
2041.00
Other IDs
FHCRC-2041.00, GEMZYME-FHCRC-2041.00, CDR0000488969
Status last verified
May 2010
First submitted
28 Jun 2006
Last updated
14 May 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-thymocyte globulin, busulfan and fludarabine phosphate in people with Chronic Myeloproliferative Disorders and Graft Versus Host Disease, run by Fred Hutchinson 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 14 May 2010. 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?

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?

Incidence and severity of acute graft-versus-host disease (GVHD). The study lists 2 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 NCT00346359.

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 14 May 2010.

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