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Chronic Myeloproliferative DisordersNCT00255684

Fludarabine, Cyclophosphamide, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing a Donor Umbilical Cord Blood Transplant for Hematologic Cancer

A study testing graft-versus-tumor induction therapy, cyclophosphamide and cyclosporine in people with Chronic Myeloproliferative Disorders and Graft Versus Host Disease, run by University of Rochester at 1 site in United States.

Terminated

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

Official record
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Trial summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy 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 Up to 75 years
What is being tested?
graft-versus-tumor induction therapy, cyclophosphamide and cyclosporine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Dec 2003to Jun 2016
Phase
Interventional
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 Up to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following hematologic malignancies:
  • Acute myeloid leukemia (AML) with or without history of myelodysplastic syndromes, meeting 1 of the following criteria:
  • In first complete remission (CR-1) with unfavorable cytogenetics and/or achieved CR-1 after ≥ 1 course of induction therapy
  • Secondary or treatment-related AML
  • In second or further complete remission
  • Relapsed with ≤ 20% blasts in the bone marrow AND no circulating blasts
  • Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
  • In CR-1 with unfavorable cytogenetics or elevated WBC at presentation OR failed to achieve CR-1 after ≥ 4 weeks of induction therapy
  • In second or further complete remission
  • Relapsed with ≤ 20% blasts in the bone marrow AND no circulating blasts
  • Other acute leukemic variants allowed at the discretion of the principal investigator
  • Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:
  • In first chronic phase AND refractory to or unable to tolerate imatinib mesylate
  • In second or further chronic phase
  • In first or second accelerated phase
  • Myelodysplastic syndromes with intermediate 2- or high-risk International Prognosis Scoring System (IPSS) score, including any of the following:
  • Refractory anemia
  • Refractory anemia with excess blasts
  • Chronic myelomonocytic leukemia
  • Myeloproliferative disorders with poor prognosis, including any of the following:
  • Myelofibrosis with myeloid metaplasia
  • No ≥ grade 3 myelofibrosis
  • Atypical CML
  • Juvenile myelomonocytic leukemia
  • Other clonal hemopathies with an accepted poor prognosis
  • Multiple myeloma with chromosome 13 abnormalities and/or progression after prior autologous bone marrow transplantation (BMT)
  • Chronic lymphocytic leukemia, meeting 1 of the following criteria:
  • Primary refractory OR relapsed and refractory disease (less than partial remission)
  • Relapsed twice on or after prior chemotherapy
  • Lymphoma, meeting both of the following criteria:
  • Hodgkin's or non-Hodgkin's lymphoma in > CR-1 OR failed primary induction
  • Chemosensitive disease, defined as > 50% reduction in mass size after the most recent chemotherapy
  • Must meet ≥ 1 of the following criteria:
  • Over 45 years of age
  • Has undergone prior autologous or allogeneic BMT
  • Charlson^ comorbidity score ≥ 2
  • Must have a high degree of tumor control (salvage therapy allowed)
  • At high risk for treatment-related mortality with a myeloablative conditioning regimen
  • No massive splenomegaly
  • Patients may become eligible after splenectomy or radiotherapy to the spleen
  • No 5/6 or 6/6 HLA-matched related donor available
  • No well-matched (i.e., ≥ 9/10 HLA match by high-resolution typing) unrelated donor available

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Transaminases ≤ 4 times ULN (unless due to underlying disease)

Renal

  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • Ejection fraction ≥ 30%

Pulmonary

  • DCLO ≥ 35%

Other

  • Negative pregnancy test
  • No uncontrolled viral, bacterial, or fungal infection
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics

Other

  • At least 3 months since prior immunosuppressive therapy
  • At least 10 days since prior salvage therapy for patients not in at least morphologic or radiologic complete remission

Trial locations and contacts

1 site in 1 country.

United States1 site
  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: Non-Myeloablative Conditioning and Unrelated Umbilical Cord Blood Transplantation for Children and Adults With Serious Oncohematologic Diseases

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy 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 system 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 transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by cyclosporine and mycophenolate mofetil works in treating patients who are undergoing a donor umbilical cord blood transplant for hematologic cancer.

Read the detailed description

OBJECTIVES:

  • Determine the frequency, extent, and rate of donor (myeloid and lymphoid) engraftment in patients with serious hematologic malignancies treated with nonmyeloablative conditioning regimen comprising fludarabine, cyclophosphamide, and low-dose total-body irradiation followed by unrelated allogeneic umbilical cord blood transplantation and post-transplant immunosuppression comprising cyclosporine and mycophenolate mofetil.
  • Correlate clinical and umbilical cord blood-related factors with engraftment in patients treated with this regimen.
  • Determine transplant-related complications, in terms of toxicity, myelosuppression, infections, and acute and chronic graft-versus-host disease, in patients treated with this regimen.
  • Determine disease-free and overall survival of patients treated with this regimen.
  • Determine treatment-related mortality of patients treated with this regimen.

OUTLINE: This is a uncontrolled, pilot study.

  • Nonmyeloablative conditioning regimen: Patients receive fludarabine IV over 30 minutes daily on days -6 to -2 and cyclophosphamide IV over 2 hours on day -6 and undergo low-dose total-body irradiation (TBI) on day 0.
  • Unrelated allogeneic umbilical cord blood transplantation (UCBT): After completion of TBI, patients undergo 1 or 2 unrelated allogeneic UCBTs on day 0.
  • Post-transplant immunosuppression: Patients receive oral or IV cyclosporine daily beginning on day -3 and continuing until day 180 and oral or IV mycophenolate mofetil twice daily on days 0-30.

Patients are followed periodically for 1 year after transplantation.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Being tested
graft-versus-tumor induction therapy, cyclophosphamide, cyclosporine, fludarabine phosphate, mycophenolate mofetil
Keywords
graft versus host disease, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, adult acute lymphoblastic leukemia in remission, recurrent adult acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia in remission, recurrent childhood acute lymphoblastic leukemia, acute undifferentiated leukemia, accelerated phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia, refractory anemia with excess blasts, refractory anemia, chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative
Medical subject headings
Myeloproliferative Disorders, Graft vs Host Disease, Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Congenital Abnormalities

What participants receive

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

Study groups in NCT00255684
Study groupRoleWhat they receive
Conditioning therapy followed by TBIExperimentalFludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
Receives: Biological: graft-versus-tumor induction therapy; Drug: cyclophosphamide; Drug: cyclosporine; Drug: fludarabine phosphate; Drug: mycophenolate mofetil; Procedure: umbilical cord blood transplantation; Radiation: radiation therapy

What is being measured

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

  1. Number of Participants Who Survived 100 Days or Longer

    Measured: 100 days

Secondary outcomes (1)
  1. Number of Participants Who Developed Acute Graft Versus Host Disease

    Measured: 3 months

Timeline

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

  1. First posted21 Nov 2005 (estimated)
  2. Study startDec 2003
  3. Primary completionMar 2013
  4. Study completionJun 2016

Why it stopped: low accrual

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00255684
Sponsor's protocol ID
CDR0000448637
Other IDs
URCC-U19403, URCC-RSRB-10063
Status last verified
Sep 2016
First submitted
18 Nov 2005
Last updated
3 Nov 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing graft-versus-tumor induction therapy, cyclophosphamide and cyclosporine in people with Chronic Myeloproliferative Disorders and Graft Versus Host Disease, run by University of Rochester 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: stopped early, as of the sponsor's last update on 3 Nov 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 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?

Number of Participants Who Survived 100 Days or Longer (time frame: 100 days). 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 3 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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