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LeukemiaPhase 2NCT00619645

Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers

A Phase 2 study testing busulfan, cyclosporine and fludarabine phosphate in people with Leukemia and Lymphoma, run by University of California, Davis 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

Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral 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 18 to 120 years
What is being tested?
busulfan, cyclosporine and fludarabine phosphate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Jun 2007to 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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosed with any of the following:
  • Acute myeloid leukemia (AML), meeting 1 of the following criteria:
  • Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required)
  • In first complete remission (CR1) with poor-risk cytogenetics, antecedent hematological disease (i.e., myelodysplasia), or treatment-related leukemia
  • Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
  • Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required)
  • CR1 with Philadelphia chromosome or poor-risk cytogenetics
  • Chronic myelogenous leukemia (CML), meeting the following criteria:
  • First or second chronic phase
  • Must be documented disease progression after imatinib mesylate therapy OR documented lack of cytogenetic response 6 months post-imatinib mesylate initiation OR imatinib mesylate intolerance
  • Chronic lymphocytic leukemia (CLL), meeting the following criteria:
  • Recurrent disease after fludarabine-based therapy
  • Must have chemosensitive disease at the time of relapse, defined as greater than 50% reduction of WBC and lymphadenopathy
  • Recurrent Hodgkin lymphoma, recurrent non-Hodgkin lymphoma (NHL) (low-, intermediate-, or high-grade disease*), or transformed NHL, meeting 1 of the following criteria:
  • Received prior autologous transplantation and cytoreductive therapy at the time of relapse to achieve complete remission (CR) or CR/unconfirmed (CRu) as defined by the International Workshop
  • Relapsed disease that required more than 2 salvage regimens to achieve CR or CRu
  • Recurrent multiple myeloma, meeting the following criteria:
  • Must have received prior autologous transplantation and demonstrate chemosensitivity at the time of relapse, defined as greater than 50% reduction of M-component or plasma-cell marrow infiltration
  • Myelodysplastic syndrome
  • Refractory anemia (RA)/RA with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD)/refractory cytopenia with multilineage dysplasia with ringed sideroblasts (RCMD-RS), or RA with excess blasts (RAEB) I, meeting the following criteria:
  • Must be transfusion-dependent and have an IPSS score ≥ 1.5, based on WHO criteria
  • No RAEB II or del(5q)
  • No uncontrolled CNS metastases
  • 5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor (both patient and donor) available

PATIENT CHARACTERISTICS:

  • Karnofsky performance status ≥ 50%
  • Serum creatinine ≤ 2 mg/dL
  • Not pregnant
  • Fertile patients must use effective contraception
  • 50 years of age or older
  • Patients 18-50 years of age are eligible if meeting 1 of the following criteria:
  • Have a preexisting medical condition
  • Received prior therapy (i.e., autologous transplantation) and are considered to be too high risk for conventional myeloablative transplantation
  • Must be willing to accept or comprehend irreversible sterility as a side effect of therapy
  • No uncontrolled active infection
  • No psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
  • Cardiac ejection fraction ≥ 30%
  • Corrected pulmonary-diffusing capacity ≥ 35%
  • No serologic evidence of infection with HIV
  • No decompensated liver disease with serum bilirubin > 2.0 mg/dL

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California Davis Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan

Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral 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 cells 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 before and after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem cell transplant together with fludarabine and busulfan and to see how well it works in treating patients with hematologic cancers.

Read the detailed description

OUTLINE:

  • Conditioning regimen: Patients receive busulfan IV over 3 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
  • Allogeneic peripheral blood stem cell transplant (PBSC): Patients undergo allogeneic PBSC on day 0.
  • Immunosuppressive therapy/graft-versus-host disease (GVHD) prophylaxis: Patients achieve100% donor T-cell chimerism on day 30 without disease recurrence, and cyclosporine A (CSA) IV continuously over 24 hours or orally every 12 hours on days -1 to 60 followed by a taper until day 100 and oral mycophenolate mofetil (MMF) once every 12 hours on days 1-40, in the absence of ≥ grade 2 GVHD.

Patients with recurrent disease or < 100% donor T-cell chimerism (on day 30) undergo a 12-day CSA and MMF taper followed by escalating doses of previously collected donor leukocyte infusion every 4 weeks until 100% donor T-cell chimerism or disease regression, in the absence of ≥ grade 2 GVHD.

After completion of study treatment, patients are followed periodically.

Keywords
recurrent adult acute myeloid leukemia, adult acute lymphoblastic leukemia in remission, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, refractory cytopenia with multilineage dysplasia, previously treated myelodysplastic syndromes, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia in remission, 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), chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, recurrent adult Hodgkin lymphoma, refractory multiple myeloma, recurrent adult acute lymphoblastic leukemia, stage III chronic lymphocytic leukemia
Medical subject headings
Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts, Anemia, Refractory

What participants receive

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

Study groups in NCT00619645
Study groupRoleWhat they receive
RIST for Heme malignanciesOtherBusulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
Receives: Drug: busulfan; Drug: cyclosporine; Drug: fludarabine phosphate; Drug: mycophenolate mofetil; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation

What is being measured

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

  1. Number of Patients With Day 100 Transplant-related Mortality

    Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.

    Measured: 24 months after day 100 transplant

Secondary outcomes (2)
  1. Number of Patients Without Progression After Day 100 Transplant

    All patients will be followed for progression for 24 months after their day 100 transplant.

    Measured: 24 months after day 100 transplant

  2. Number of Patients Alive 24 Months Post Day 100 Transplant

    Patients will be followed for survival for 24 months post day 100 transplant.

    Measured: 24 months post day 100 transplant

Timeline

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

  1. First posted21 Feb 2008 (estimated)
  2. Study startJun 2007
  3. Primary completionOct 2013
  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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00619645
Sponsor's protocol ID
UCDCC#196
Other IDs
288263, UCD-196
Status last verified
Jan 2018
First submitted
20 Feb 2008
Last updated
10 Jan 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing busulfan, cyclosporine and fludarabine phosphate in people with Leukemia and Lymphoma, run by University of California, Davis 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 10 Jan 2018. 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 8 May 2017). 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 Patients With Day 100 Transplant-related Mortality (time frame: 24 months after day 100 transplant). 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 10 Jan 2018.

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