AzTrials
AzTrials

LeukemiaPhase 2NCT00317785

Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases

A Phase 2 study testing cyclophosphamide, cyclosporine and methotrexate in people with Leukemia and Lymphoma, run by Fred Hutchinson Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal cells. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Leukemia, Lymphoma, Myelodysplastic Syndromes
What is being tested?
cyclophosphamide, cyclosporine and methotrexate
Type of treatment
Surgery or procedure
How many people
50 participants
Where
2 sitesUnited States
Study dates
May 2005to 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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of a hematologic cancer or other disease that is unlikely to respond to conventional treatment, including any of the following:
  • Chronic myelogenous leukemia
  • Acute myeloid leukemia
  • Acute lymphocytic leukemia
  • Myelodysplastic syndromes
  • Lymphoma
  • Patients who have bulky tumor mass must not require additional involved-field irradiation
  • Planning to undergo conditioning for transplantation at the Seattle Cancer Care Alliance and University of Washington Medical Center
  • Must have an HLA-matched donor available
  • No donors who are mismatched for > 1 HLA class I antigen or allele
  • Negative anti-donor lymphocytotoxic crossmatch

PATIENT CHARACTERISTICS:

  • Life expectancy must not be severely limited by diseases other than malignancy
  • No moribund patients
  • Creatinine ≤ 1.2 mg/dL
  • Oxygen saturation on room air ≥ 93%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HIV positivity
  • No cirrhosis
  • No hepatic fibrosis with bridging
  • No fulminant hepatic failure
  • No acute liver injury
  • No persistent cholestasis
  • No infection requiring systemic antibiotic or antifungal therapy
  • No coronary artery disease
  • No congestive heart failure requiring therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior hematopoietic stem cell transplantation
  • No prior radiation therapy to the liver or adjacent organs
  • More than 30 days since prior cytoreductive chemotherapy for patients with a large body burden of tumor cells
  • No concurrent enrollment in a phase I study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1023

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: A Phase II Trial of Total Body Irradiation Plus Metabolism-Based Cyclophosphamide Dosing as Preparative Therapy for Allogeneic Hematopoietic Cell Transplant for Patients With Hematological Malignancy

RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving total-body irradiation together with cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for hematologic cancer and other diseases.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the potential efficacy of targeting cyclophosphamide to a metabolic endpoint when given together with total-body irradiation, in terms of day 200 nonrelapse mortality, in patients with hematologic cancer and other diseases who are undergoing allogeneic hematopoietic stem cell transplantation.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine the rate of relapse in patients treated with this regimen.
  • Determine the occurrence of sinusoidal obstruction syndrome in patients treated with this regimen.
  • Determine the occurrence of acute renal failure in these patients.
  • Determine the occurrence of respiratory failure in these patients.

OUTLINE:

  • Conditioning regimen: Patients undergo total-body irradiation twice daily on days -6 to -4. Patients also receive cyclophosphamide IV over 1 hour on day -3 and then IV at a metabolism-based dose* on day -2.

NOTE: *Patients undergo frequent blood sampling after completion of the first cyclophosphamide infusion for pharmacokinetic studies in order to determine the dose for the second cyclophosphamide infusion.

  • Allogeneic stem cell transplantation: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
  • Graft-versus-host disease (GVHD) prophylaxis: Patients receive GVHD prophylaxis as per the attending physician, including one of the following regimens: cyclosporine and methotrexate; tacrolimus and methotrexate; tacrolimus and mycophenolate mofetil; or sirolimus, tacrolimus, and methotrexate (as per the GVHD prophylaxis regimen chosen for each patient).

After completion of study treatment, patients are followed periodically for at least 200 days.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Keywords
adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, de novo myelodysplastic syndromes, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 1 follicular lymphoma
Medical subject headings
Leukemia, Lymphoma, Myelodysplastic Syndromes, Congenital Abnormalities, Leukemia, Myeloid, Accelerated Phase, Blast Crisis, Leukemia, Myeloid, Chronic-Phase, Lymphoma, B-Cell, Marginal Zone

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. Non-relapse mortality (NRM) at 200 days

Secondary outcomes (6)

  1. Overall survival

  2. Relapse rate

  3. Sinusoidal obstruction syndrome (SOS)

  4. Acute renal failure

  5. Respiratory failure

  6. Cause of death

Timeline

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

  1. First posted25 Apr 2006 (estimated)
  2. Study startMay 2005
  3. Primary 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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317785
Sponsor's protocol ID
1998.00
Other IDs
FHCRC-1998.00, CDR0000471840
Status last verified
May 2010
First submitted
24 Apr 2006
Last updated
7 May 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cyclophosphamide, cyclosporine and methotrexate in people with Leukemia and Lymphoma, run by Fred Hutchinson Cancer Center at 2 sites 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 7 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 2 sites 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?

Non-relapse mortality (NRM) at 200 days. 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 NCT00317785.

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 7 May 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

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